DBS Adverse Event Reports


DBS Adverse Event Reports filed with the FDA
DBS Adverse Event Reports Filed to the FDA from July 2011 to January 2013 

Here is a
link to a sortable spreadsheet enabling a 'meta' analysis of all the filed reports.

Keep in mind that every patient in each of these reports thought their DBS implantation would go well.

Here's one as an example: 

Reportable event: the authors report that following surgery, one pt did not have a follow-up assessment because of encephalopathy of unk [unknown] original (presumed to be allergic) following electrode implantation which required removal of all dbs hardware a few days later (within the first 2 weeks). See literature article attached to mfr report # 3007566237201107448. [emphasis added]

Each of these are from the FDA's public record source for adverse events which can be found here: 

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/results.cfm?start_search=1&searchyear=&productcode=&productproblem=&devicename=&knumber=K&pmanumber=P&manufacturer=medtronic&brandname=deep%20brain&eventtype=&reportdatefrom=01%2F01%2F2010&reportdateto=01%2F31%2F2013&pagenum=10&key_count=531

As you can see there are 531 for the time period covering January 2010 to December 2012 (three years).  If you go to the site, click on the link in the column with the heading 'Brand Name' to find the actual report. 

Some are very 'curious' and if you own a hybrid, let me know!


Event: a (b)(6) man with history of tremor-dominant parkinson's disease (pd) underwent bilateral subthalamic nucleus deep brain stimulator (stn dbs) placement. One month later, initial stimulator programming was performed, and he complained of symptoms of severe nausea, dizziness, and palpitations while driving the 4- to 5-hour journey home in a 2008 hybrid toyota prius car. The patient's wife had to stop the car multiple times as he felt so ill. Prior to initial programming, the patient was able to drive and ride in the prius without any problems. After stimulator activation, the patient complained of reproducible symptoms of nausea, dizziness, lightheadedness, and cardiac palpitations when sitting in the front passenger seat. He noticed that the symptoms worsened when both the gasoline engine and electric motor were running or when the car battery was charging. The symptoms spontaneously resolved when he exited the car and never occurred when he was in his truck, which is a non-hybrid vehicle. The symptoms also improved when he manually turned off his stimulator while inside the prius or when he moved to the back seat. These symptoms did not occur at any other time. On interrogation of his stimulator 4 weeks after the initial dbs programming, seven activations were noted with only two that were accounted by the patient turning the pulse generator off and on manually. The internal pulse generators (ipgs), however, had been on 99% of the time. The patient experienced the worst symptoms when sitting in the front seat of the prius and when the car battery was being charged, suggesting that the electromagnetic field emitted might be interfering with his neurostimulator settings. There were multiple unaccounted activations on interrogation of the stimulator, although the ipgs were on 99% of the time. He did not get symptoms in a non-hybrid car or in the prius when his ipg was off. We have observed similar symptoms when the voltage of an stn neurostimulator was increased rapidly. We hypothesize that the device was turning off and on rapidly, with voltage surges, thus causing the patient's symptoms.

For your convenience, I have copied the 'event description' from a sample of them below.

And it appears to be a problem that has been known about for quite a while...





When asked about allergies or swelling resulting from DBS implantation, here's what the MedTronic rep said:

From: Owen, Catie <catherine.d.owen@medtronic.com>
Date: Mon, Aug 1, 2011 at 4:23 PM

Subject: RE: DBS Issue

To: Joe Vincoli joevincoli@gmail.com

Joe,

Here is a quick answer to your concerns:

- In order for you to have a product liability suit there had to have been a defect in the product. A person's allergic reaction to a product manufactured as it was intended is not a defect. Just as you can't sue a penicillin company for an allergy to penicillin, you cannot sue Medtronic for his allergic reaction to the lead. The lead was made with a substance that is known for its biocompatibility with the human body. Millions of people all over the world have Medtronic leads implanted in them without any reaction. Your father-in-law is quite rare and it is his own body that caused his reaction. I am really sorry that this happened to him but it was not caused by any negligence on Medtronic's part. Medtronic is not liable in this matter. If you have any questions regarding Medtronic's position on this matter, please write me back or have your legal counsel contact me.

Catie Owen
Neuromodulation Patient Relations
 

I think Ms. Owen has made an assumption as to the causal agent for the swelling.  

The key issue is edema (swelling) along the path of the leads.  

This is referred to as 'hypodensity' in a CT scan and T2 instability on an MRI. It is noticed 'along the path of the leads'.  

When it happens it is usually treated by a large dose of steroids.   

Ed's physicians thought at first he was having an infection.   At the same time the cultures came back negative for infection they noticed that the swelling was setting up along the path of the second lead.  They immediately shifted from 'infection' to 'allergic reaction'.  

By this time is was too late and the brain's swelling exceeded either the skull's capacity or some other 'tipping point'.  

But was this a unique, allergic reaction? 

Was, as Ms. Owen states, Ed 'quite rare'?      

Or, was it just a common, normal, biological reaction to being 'impaled' or 'lanced' by the lead?  

The Englot study noticed a 10% incidence of swelling after DBS implantation.  

In that study, all the cases with swelling were in patients with bilateral placements.  

If the cause for Ed was 'allergy' then one would think allergic swelling would show up equally in bilateral as well as unilateral implantations.  

I think the study below provides the key.  

Perhaps the swelling is not due to 'allergy' but rather to 'microlesioning'...the physical disruption of the grey matter (neural ganglia) as the lead is passed through.  

I use the analogy of pepper...you can take so much but when it crosses a point you sneeze. Similarly, it appears that the brain can handle one lead but when a second lead is inserted at the same time (meaning not at a later surgical procedure) the brain can't handle the cumulative microlesioning. It either exceeds the brain's tolerance level or perhaps the skull's capacity for expansion.   

The study below was done at Emory was published in 2010 (Ed's surgery was in April 2010).  

First of all, it appears that at Emory they do not do both leads at the same time. It appears (at least at the time this study was done)  that they do one side and then do the other side at a later date.  

In the study they did three MRIs. One after initial placement. The second after 20 months.  The third after implantation of the second lead.  

The first was performed within 24 hrs after the first dbs placement, the second occurred prior to the contralateral second dbs placement which was an average of 19. 4 months later, and the third was within 24 hrs after the second dbs placement.  

Here's what they found. The sample size was 64.  

Seven pts experienced edema. The edema appeared on the mr images taken immediately after lead placement, either on the first set of mr images or the images obtained immediately after the second lead insertion, but never on the second set of images that was performed months after the first insertion. The edema surrounded the acutely implanted lead and never was seen surrounding the chronically implanted lead. It was concluded that the edema resulted solely from micro-electrode and/or dbs-induced injury. Six pts experienced focal intraparenchymal hemorrhage. This was seen either on the first or third mr imaging sessions, but never on the second. Four pts experienced intra-ventricular hemorrhage. This was seen either on the first or third mr imaging sessions, but never on the second. One pt experienced infarct that was noted 2 days after the second dbs placement and confirmed on the repeated mr imaging studies obtained 2 weeks thereafter. One pt experienced sulcal subarachnoid blood. Seven pts experienced encephalomalacia surrounding the first dbs lead secondary to gliosis that was noted on long-term mr imaging sequences. This pattern was consistent with insertional injury. Most of these cases of encephalomalacia occurred after documented traparenchymal hemorrhage or edema on immediate mr imaging following the first or second lead placement. No events were attributed to effects of mr imaging.  

Literature: chhabra v, sung e, mewes k, bakay ra, abosch a, gross re. Safety of magnetic resonance imaging of deep brain stimulator systems: a serial imaging and clinical retrospective study. J neurosurg. 2010;112(3):497-502.

The
Englot study found a swelling incidence rate (T2 instability) of 10 to 11%. Here it is 10% as well.  

I think bilateral, simultaneous implantation creates more injury and concomittant swelling than the brain or the skull's volume can handle.   

As such, I do not believe Ed's case is a 'unique', one in a one hundred thousand allergic reaction.

Here is another case recently published through the NIH:

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3236534/

 

Dementia after DBS Surgery: A Case Report and Literature Review

 

Parkinsons Dis. 2011; 2011: 679283.

Published online 2011 November 29.  doi:  10.4061/2011/679283

PMCID: PMC3236534

 

I. Rektorova, 1, 2  * Z. Hummelova, 1  and M. Balaz 1, 2 

 

Abstract.

 

We report the case history of a 75-year-old woman with Parkinson's disease who developed severe cognitive problems after deep brain stimulation (DBS) of the bilateral subthalamic nuclei (STN). After a brief cognitive improvement, the patient gradually deteriorated until she developed full-blown dementia. We discuss the case with respect to the cognitive effects of STN DBS and the possible risk factors of dementia after STN DBS surgery.

 

2. Case History

 

 A 61-year-old woman was diagnosed with PD in 1991. She had no family  history of PD and she had not been chronically treated for any other  medical condition. She worked as a high school teacher until the age of 65.

….

No complications were observed at the time of surgery; the patient  remained conscious, alert, and cooperative during all stages of the  procedure. Nevertheless, on the day after the electrode implantation,  a transient somnolence, disorientation in time and space, and retrograde amnesia occurred. This acute confusion regressed within 4  days. The electrode cables were internalized, and a neurostimulation  device (Kinetra, Medtronic Inc., Minneapolis, USA) was implanted. The  patient was released from the hospital. She was rehospitalized one month later in order to start the stimulation.

 

 In January 2006, a neuropsychological examination was performed with  the stimulation off while the patient was on stable dopaminergic  medication. It revealed a moderately intense organic psychosyndrome  and a marked dysexecutive syndrome with a major impact on other cognitive functions and instrumental activities of daily living. It manifested symptomatically by decreased psychomotor speed,  flexibility, spontaneity, and concentration, as well as attention deficits and disinhibition (see Figure 1 for the intersecting pentagons drawing from the Mini-Mental State Examination (MMSE,  [13])). Mild memory impairment was also identified, affecting primarily recent episodic and semantic memory. Visuospatial deficits, dyscalculia, and deficits in time orientation were also reported, and the patient became negativistic and dysphoric. Her MMSE score was 14  points and the Montgomery-Asberg Depression Rating Scale (MADRS) score was 24 [13]. We performed brain MRI and FLAIR sequences to verify the electrode location and to rule out possible adverse effects of  implantation. The electrode location was correct; however, mild oedema and bleeding were found in the anterior limb of the left internal  capsule, spreading to the putamen and caudate head (see Figure 2(a)).

….

During the summer of 2006, the patient's medical condition again started to gradually deteriorate, with episodes of freezing of gait and postural instability, visual hallucinations, and delusions. The behavioural disturbances were worse in the morning. The patient experienced no tremor. Sometimes she had very mild dyskinesias on the left side, but no motor fluctuations were present. She left the house and got lost repeatedly, and she became partially dependent on the caregiver (her husband). Quetiapine was started at that time with a dose titration up to 75mg per day; this was later exchanged for clozapine in low doses (50mg per day). All other medications except L-dopa (550mg/day) and citalopram (20mg/day) were withdrawn. Cognitive testing in March 2007 confirmed the cognitive decline, with a Mattis Dementia Rating Scale score of 116 points and an IQ score measured at 90. In addition to dysexecutive syndrome, memory functions, and praxis, visuoconstructive, visuospatial, and other cognitive functions were impaired, including writing and picture drawing.

 

In 2008, full-blown dementia was reported, which progressed over time. Memantin (20mg per day) was introduced, but no visible effect on slowing the dementia course was detected. In December 2008, a marked overall brain atrophy was depicted in brain MRI, including both hippocampi. White matter hyperintensities along the electrode trajectories (possible gliosis) were also visible (see Figure 2(c)). In 2009, the MMSE score was 19, and according to the 7-min subtests [13], orientation in time score was 74, enhanced cued memory score was 8, the clock test score was 1, and semantic verbal fluency was 5. In February 2010, the stimulation battery was changed, with the last stimulation parameters being as follows: amplitude 3.6V and 3.8V for the left and right sides, respectively, stimulation frequency 130Hz, pulse width 90μsec. The MMSE was 14. The patient suffered from hallucinations, delusions, and postural instability with occasional falls. She had severe aphasia and dysarthria with telegraphic slurred speech and moderately severe motor and ideomotor apraxia. She became incontinent, and fully dependent on her husband. She died in April 2010. The probable cause of death was pneumonia. No brain biopsy was performed.

….

 Another interesting issue that has to be taken into consideration relates to possible gliosis along the electrode trajectories. It has been shown by others [39] that DBS electrodes may cause a giant cell reaction or gliosis around them when implanted in the brains of patients with PD. This reaction is present from 3 months to at least 31 months onwards after implantation, and may possibly represent a response to the polyurethane component of the electrodes' surface coat. The accumulation of inflammatory tissue occurs predominantly around the electrode sheath rather than tip, and it is conceivable that on the whole it plays only a small role in maintaining benefit or causing side effects of DBS [39].

 

 Finally, we indeed cannot exclude a possibility that the ICH as an adverse event of the STN implantation might not only have caused an acute cognitive and behavioural impairment after the procedure but might also have accelerated the development of dementia in our patient, probably as a result of collapsed brain reserve and disturbed compensatory mechanisms caused by the electrode implantation and IHC.  Age was probably the major contributor and risk factor for the intracranial bleeding, postoperative confusion, and later dementia development [26, 40, 41].

 

 Despite many unresolved questions, this has taught us not to include PD patients above 70 years of age for the DBS surgery. In addition, the length of PD duration should also be taken into consideration, and the question remains as to what the best time for considering DBS in PD would be. Further research should focus on potential biological markers such as specific brain imaging techniques and cerebrospinal fluid examination that would better predict the disease prognosis and that might help to better select good candidates for DBS surgery in PD patients.



I think these cases are the result of a simple failure to understand that when you impale or lance something with a lead it tends to swell as a result (granted the skin's mechanisms and the brain's are different) and that when something swells if it is in a constricted space (skull) then pressure builds which causes brain damage.   

I believe this is a clear and present danger brought on by bilateral, simultaneous implantation.  

Here are the adverse events reported to the FDA from 2010 to 2013 that cite edema.

Specific Edema Citings in DBS Adverse Event Reports filed to the FDA between 2010 and 2013

 8/10/2011          3007566237-2011-07765
Reportable event: one (b)(6) male presented to the emergency room complaining of a headache (b)(6) following gpi dbs implantation. Edema was found at the tip of the lead. The pt was given steroids for (b)(6) for this to resolve.

 

8/10/2011          3007566237-2011-07706
Reportable event: one (b)(6) left-handed male with a history of idiopathic parkinson's disease (pd) was admitted for placement of a right-sided stn electrode. Immediate post-operative ct head scans revealed minimal pneumocephalus with no parenchymal hemorrhage. The pt was discharged on postoperative day 2 with a normal exam. His second stage of surgery for implantation of the ipg was scheduled for a later date. Two weeks after discharge, the pt presented to the emergency room with a history of a single generalized convulsion followed by a brief loss of consciousness. On exam he was orientated and had no focal deficits. A ct brain scan revealed a large hypodense area (3cmx4cmx3cm) centered around the left dbs electrode primarily in the subcortical region and centrum semiovale that did not enhance on contrast administration. No local or systemic signs or symptoms of infection were present. He did not have any further episodes of seizure and was discharged home on anti-convulsant medication and a short course of oral steroids. A f/u ct scan after 1 week showed resolution of the edema. The pt was not given antibiotics.

 

8/3/2011            3007566237-2011-06834
It was reported that the patient was implanted with an activa rc on (b)(6) 2011 and everything was ok. The patient came to a consultation in (b)(6) 2011 / (b)(6) 2011 because she didn't feel well. The stimulator and impedances were ok, but the doctor saw an edema around the two electrodes and had a suspicion of infection. The doctor stopped stimulation, but could not confirm an infection. The doctor started a treatment with medrol and the patient seemed to improve, but the activa rc was not restarted.

Report number not recorded by accident.
Event: following the second stage of the stn-dbs surgery during which the stimulator was implanted and during which the pt had mechanical ventilation, the pt's trachea was extubated and the pt was moved to the icu. On the fifth post-operative day, 40 mg of enoxaparin was administered to prevent deep vein thrombosis. The pt became unresponsive within a few hours of administration. The pt was reintubated and taken for a ct scan which revealed an intracerebral hematoma in the left basal ganglion and left fronto-parietal region with midline shift and perilesional edema. Prothrombin time and activated partial thromboplastin time were prolonged with a normal platelet count. Enoxaparin was discontinued and six units of fresh frozen plasma were transfused, while mechanical ventilation was continued. The pt's coagulation status returned to normal within the next four days, and there was an improvement in neurological status. The hematoma had resolved and was not expanding so no evacuation was performed. The pt then developed ventilator-associated pneumonia and sepsis due to methicillin-resistant staphylococcus aureus on post-operative day 25.

 6/10/2010          3007566237-2011-03958
Reportable event: Two patients experienced seizures that were considered surgery related, dbs-specific. One pt experienced visual neglect from edema that was considered surgery related, dbs-specific.

 4/16/2010          3007566237-2011-03632
Literature: chhabra v, sung e, mewes k, bakay ra, abosch a, gross re. Safety of magnetic resonance imaging of deep brain stimulator systems: a serial imaging and clinical retrospective study. J neurosurg. 2010;112(3):497-502. Summary: this study aimed to examine the safety of mr imaging in 64 pts who underwent staged bilateral implantations of dbs electrodes at emory university hospital between (b)(6) 1997 and (b)(6) 2006 for parkinson disease, tremor and dystonia. Each pt underwent three separate mr imaging sessions subsequent to dbs placement. The first was performed within 24 hrs after the first dbs placement, the second occurred prior to the contralateral second dbs placement which was an average of 19. 4 months later, and the third was within 24 hrs after the second dbs placement. F/u was conducted to examine adverse events related either to mr imaging or to dbs-induced injury. Reportable events: one pt experienced encephalomalacia surrounding the first dbs lead secondary to gliosis that was noted on long-term mr imaging sequences. This pattern was consistent with insertional injury. The pt had an ablative procedure performed by intentionally subjecting a dbs lead to radiofrequency currents prior to its removal. Seven pts experienced edema. The edema appeared on the mr images taken immediately after lead placement, either on the first set of mr images or the images obtained immediately after the second lead insertion, but never on the second set of images that was performed months after the first insertion. The edema surrounded the acutely implanted lead and never was seen surrounding the chronically implanted lead. It was concluded that the edema resulted solely from micro-electrode and/or dbs-induced injury. Six pts experienced focal intraparenchymal hemorrhage. This was seen either on the first or third mr imaging sessions, but never on the second. Four pts experienced intra-ventricular hemorrhage. This was seen either on the first or third mr imaging sessions, but never on the second. One pt experienced infarct that was noted 2 days after the second dbs placement and confirmed on the repeated mr imaging studies obtained 2 weeks thereafter. One pt experienced sulcal subarachnoid blood. Seven pts experienced encephalomalacia surrounding the first dbs lead secondary to gliosis that was noted on long-term mr imaging sequences. This pattern was consistent with insertional injury. Most of these cases of encephalomalacia occurred after documented intraparenchymal hemorrhage or edema on immediate mr imaging following the first or second lead placement. No events were attributed to effects of mr imaging. 

1/21/2011          3007566237-2011-01175
Reportable event: one pt experienced a small delayed superficial cortical hemorrhage with mild postoperative dysarthria which resolved within 1 month of surgery and was thought to be unrelated to the bleed, and probably related to immediate postoperative edema around the electrode tip, given that this dysarthria could be reproduced by high-voltage stimulation on long-term f/u. There was no other hemorrhagic complication in this series of patients.

 12/5/2010          3007566237-2010-10766
The hcp noted an area of hypodensity in a pt treated with deep brain stimulation. He was in the process of evaluating the event as a possible stroke.

4/18/2010          3007566237-2010-03886
(According to the FDA, this is Ed’s adverse event report as filed by Medtronic.)
One week after implant, the leads were removed due to an allergic reaction. The patient developed an infection and edema from the bur hole down to the brain. As of (b) (6) 2010, the patient was in the intensive care unit. Additional information has been requested, a follow-up report will be sent if additional information becomes available.

 4/8/2010            3007566237-2010-03702
Event: The patient, a (b)(6) male with parkinson's disease (pd), had been operated with left-sided vim dbs 7 years before. Due to suboptimal treatment results and disease progression, it was decided to replace the electrode with bilateral electrodes in the zona incerta. The old electrode, which was found to be broken, was removed 2 days before the procedure to facilitate mri. A ct on postoperative day 5 demonstrated an edema around the right electrode, with progression on the following day and a contrast-enhanced area around the edema. Furthermore, similar changes but to a lesser extent were noted around the left electrode. These changes were interpreted as cerebritis with developing abscess. The patient was initially treated with intravenous (vancocin and meronem) and later with oral antibiotics for 8 weeks. Twenty days after the operation, ct demonstrated apparent amelioration of intracerebral changes and recovery of the patient. An mri did however reveal remaining edema on the right side, especially around the tip of the electrode. For this reason, the right electrode was removed. Bacterial culture from the electrode demonstrated growth of (b)(6). Eleven weeks after the initial operation and 3 weeks after discontinuation of antibiotic treatment, the patient presented with headache, vertigo and later rupture of the cranial incision above the entry of the electrode with pus. The patient recovered without any permanent sequelae.

2/5/2010            3007566237-2010-01754
[IS SHIFTING DUE TO UNDETECTED EDEMA?]
Reportable event: some pts appeared to have a significant shift in the location of the electrodes between the immediate and 6-month post-operative ct. The shift moved in the ventral direction. The shift was felt to be partly due to csf leakage during the operation. No pt treatment or outcome was reported.

Here's the list of adverse events citing 'infection'...some of which could be 'edema' misdiagnosed.

You make the call…Infection or Edema…or both?

10/6/2010          3007566237-2010-09020
Reportable event: one patient experienced an infection of the intracranial lead: the control mri showed a signal change in both t1 and t2 sequences along the lead. Cultures were negative; the patient underwent the removal of the infected electrode and was started on an antibiotic therapy. The pt was successfully reimplanted 6 months later after resolution of the infection. This complication required a longer in-hospital stay for the patient however, the patient did not show significant comorbidity.

1/25/2010          3007566237-2010-01279
It was reported the patient has a dbs system for treatment of dystonia. The device was originally placed in (b) (6), 2007. The patient has had great benefit but has had the right side device removed 4 times due to infection. No other information was provided. This report is submitted for infection event 1 of 4.

3007566237-2011-08432
It was reported the pt presented to the emergency room with severe eye/facial pain and swelling on the left side. There was also redness and swelling a the coronal incision site. A computed tomography (ct) scan of the head and lumbar puncture was performed and the results were "negative. " it was determined the pt had cellulitis and treatment was started with vancomycin. The pt improved with the vancomycin treatment, and the pt was switched to bactrim in preparation for discharge. Later the pt awoke from sleep with swollen eyes and a severe, throbbing headache. The pt also had retro-orbital pressure, which was new. The pt was put on iv vancomycin and ceftazidime. A magnetic resonance imaging (mri) was performed, and the result showed no intracranial abscess or infection. The pt was to be discharged on iv antibiotics.

3007566237-2011-08278
It was reported that the patient developed an infection their right lead, and the lead was removed. There was no outcome reported from the surgery. No further follow up is possible.

3007566237-2011-08167
It was reported that the patient underwent an implant for parkinson's. After he received the surgery he developed an infection and was oozing from his head. It was reported that the patient was still alive, but very ill. Additional information has been requested, but was not available as of the date of this report.

3007566237-2011-07027
Reportable event: the authors reported that one pt had a hardware infection in the first 3 months after surgery. [Vague] This complication was related to technical factors [Vague], including externalization of electrodes. The hardware was replaced without complication and with continuing clinical benefit. The source literature did not specify which device model was used. See literature article with mfr report# 3007566237-2011-07025.  Manufacturer Narrative  (b)(4). It was not possible to ascertain specific device info from the article or to match the events reported with previously reported events. At this time no add'l info was available, add'l info regarding the pt and the device has been requested.

3007566237-2011-05262
Reportable event: during the first 6 months after the operation, two patients had their stimulation electrodes removed due to an infection and one pt committed suicide.

3007566237-2011-04171
Reportable event: a (b)(6) female, pt, with cerebellar tremor, cerebellar degeneration, and peptic ulcer disease experienced a deep infection with purulent drainage in the right frontal burr hole incision 22 days after implant. A culture came back positive for (b)(6) and (b)(6). The pt underwent incision and debridement with right lead removal and was treated with intravenous antibiotics. Antibiotics were continued for at least 6 weeks. A weekly f/u was undertaken with examination of the wound until it was completely healed.

3007566237-2011-03628
Reportable events: One male pt, (b)(6) at the time of initial implantation surgery, developed a 'hardware' infection. One male pt, (b)(6) at the time of initial implantation, developed a 'hardware' infection [Vague].  Manufacturer Narrative (b)(4). It was not possible to ascertain specific device info from the article or to match the events reported with previously reported events. At this time no add'l info was available, add'l info regarding the pt, event, interventions and outcome has been requested.

7/14/2010          3007566237-2011-03630
Reportable events: one pt experienced wound infection [Vauge]. One pt experienced a stimulation induced hemiballism. One pt experienced an asymptomatic intracerebral hemorrhage.  Manufacturer Narrative  (b)(4). It was not possible to ascertain specific device info from the article or to match the events reported with previously reported events. At this time no add'l info was available, add'l info regarding the pt, event, interventions and outcome has been requested.

4/14/2011          3007566237-2011-03552
Reportable event: one patient experienced a (b)(6) adverse event, their leads became infected. The infected device components were removed and re-implanted following an appropriate course of intravenous antibiotics.  Manufacturer Narrative  (b)(4). It was not possible to ascertain specific device information from the article or to match the events reported with previously reported events.

4/14/2011          3007566237-2011-03540
[Note how the fact that the one patient being on immunosuppressants causes us to discount the other patient’s status].
Reportable event: the authors report two infections of the implanted devices; one patient was under immunosuppressant therapy following a renal transplant.  Manufacturer Narrative  (b)(4). It was not possible to ascertain specific device information from the article or to match the events reported with previously reported events.

8/26/2009          3007566237-2011-03451
[Ridiculous…I believe this was filed by MedTronic staff.]
Rec'd info, the physician had a pt with an infection at one time. He now uses vancomycin for protection. No further info provided.

3/22/2011          3007566237-2011-03012
Reportable events: the complication rate was low with no mortality or hemorrhages. It was reported that one pt had a minor complication related to surgery; the pt experienced acute chest pain, probably attributed to cardiac ischemia and the dbs procedure was discontinued prior to implanting the electrodes. Two months later, the pt was operated for unilateral vim-dbs. One pt had a minor complication related to surgery; the pt experienced discomfort caused by tight dbs wires in the neck region and was re-operated after 7 months. There were no infections related to lead implantation, but two cases developed a mild local infection following a change of battery 5 years after dbs implantation. There were several transient neurological side effects; apraxia of eyelid opening (n=2), anxiety and depression (n=3) and hypomania (n=3). There were 4 cases of permanent cognitive impairment. Manufacturer Narrative  (b)(4). It was not possible to ascertain specific device information from the article or to match the events reported with previously reported events. It is also possible several events occurred in one pt. At this time, no additional information was available, additional information regarding the pt, event, interventions and outcome has been requested.

3/18/2011          3007566237-2011-02901
Reportable event: fourteen of the 44 pts had a total of 18 revisions. Two pts that had a new lead put in place because of dislocation [EDEMA?], nine pts had a new lead put in place because of lead fracture, with four of these pts undergoing a second revision, again lead replacement. In three cases there was a problem with the connection, with pain due to local current leakage, requiring opening of the connection and cleaning it. There were two instances of infection, one at the level of the lead insert during the trial period, and one later after implantation at the level of the connector due to a small skin defect. Both infections were resolved with short-term antibiotic treatment.   Manufacturer Narrative (b)(4). It was not possible to ascertain specific device information from the article or to match the events reported with previously reported events. At this time no additional information was available, additional information regarding the pt, event, interventions and outcome has been requested.

2/28/2011          3007566237-2011-02269
Reportable event: one yopd patient experienced an infection. See literature article with mfr report# 3007566237-2011-02256. It was not possible to ascertain specific device information from the article or to match the events reported with previously reported events. The patient information provided in section a is the average for all the patients within the yopd group. At this time, no additional information was available, additional information regarding the patient, event and outcome has been requested.

2/7/2011            3007566237-2011-01348
The ins and extension were removed due to infection. Details were not provided. Further information is being requested at this time

1/27/2011          3007566237-2011-01123
The deep brain stimulator system was infected with staphylococcus aureus. The devices were explanted and the patient was treated with antibiotics. The patient was hospitalized associated with the infection. Additional information has been requested. A follow-up report will be submitted if additional information becomes available.

1/12/2011          3007566237-2011-00638
[Props for the Medtronic rep]    
Received information there was an infection at the lead/extension area. Medtronic representative was inquiring about cleaning the area with either betadine or hydrogen peroxide. No other information was provided. Additional information has been requested and if received a follow report will be sent.

11/22/2010        3007566237-2010-10074
Reportable event: this report is for one pt who developed postoperative infection requiring dbs lead removal, intravenous antibiotics, and subsequent reimplantation. The source literature did not specify which device models were used.

10/28/2010        3007566237-2010-09384
It was reported that the pt felt pain in the lead, and the health care professional (hcp) found signs of lead "exposion" and believed there might have been infection. The lead and extension were explanted. It was later reported that the pt subsequently went to the hosp, and the hcp found no swelling, ulceration, or lead "exposion". No infection was found. It was noted that the pt felt pain behind the ear. The hcp was "observing" the pt.  Manufacturer Narrative  (b)(4): the lead and extension have been returned to the mfr for analysis. A f/u report will be sent when the analysis is complete.

10/6/2010          3007566237-2010-09014
Reportable event: one patient experienced an infection of the intracranial lead: the control mri showed a signal change in both t1 and t2 sequences along the lead. Cultures were positive for (b)(6); the patient underwent the removal of the infected electrode and was started on an antibiotic therapy, but refused to undergo a second surgery. This complication required a longer in-hospital stay for the patient however the patient did not show significant comorbidity.

10/6/2010          3007566237-2010-09005
Reportable event: one pt experienced an aspiration pneumonia 1 week after surgery while still in hospital. This resulted in severe lung infection and respiratory failure, requiring admission to the intensive care unit, tracheostomy, and wide-range antibiotic therapy. Despite maximal treatment, the pt eventually died a few weeks later. He was one of the oldest patients in our series (70 years at surgery) and presented with severe pd. Dysphagia was present preoperatively and did not improve after surgery. See literature article with mfr report #3007566237-2010-08991.

9/28/2010          3007566237-2010-08430
It was reported patient had deep brain stimulation (dbs) system in 2004 and changed to implantable pulse generator (ipg) in (b)(6) 2008. According to patient, "the incision on the left side head occurred purulence about a month ago". When he returned to the hospital for programming, physician identified it as infected. After communicating between patient and company, physician decided to remove the infected electrode. The surgery was planned for (b)(6) 2010. The lead was explanted. At the time of this report, no further details were reported. Add'l info was requested and will be provided when it becomes available.

9/22/2010          3007566237-2010-08435
Event: the frequency of the 300 adverse events were as follows: mental status decline 53, other (unspecified) 43, gait problem 21, other motor problem 20, seizure 16, ich (symptomatic) 16, lead misplacement 15, speech-aphasia 13, speech-dysarthria 11, subdural/other bleed 11, mania/hypomania 8, infection, deep (hardware removal) 7, air embolus 6, speech-hypophonia 6, depression 6, infection, deep (revision, iv antibiotics) 5, swallow problem 5, anxiety 5, incontinence 4, visual problem 4, infection, superficial (oral antibiotics) 4, hardware malfunction (other) 4, death 2, hardware malfunction (fracture) 2, hydrocephalus 2, neurological deficit (other) 2, stroke 2, scalp erosion 2, suicidal ideation 2, ipg seroma 1, other sensory problem 1 and psychogenic disorder 1. See attached literature article.

5/13/2010          3007566237-2010-
The only complication with this group presented with an infection of a surgical wound. Both inability and disability improved, and remained stable after two yrs.

4/18/2010          3007566237-2010-03886
[Ed’s case…see how it looks like infection is the causal agent?...even though his doctor’s meticulously put in his record that there was no sign of infection?  Would Medtronic file this way on one of your patients if they filed this way on Ed?...assuming the FDA is correct and this is Ed’s filing].
One week after implant, the leads were removed due to an allergic reaction. The patient developed an infection and edema from the bur hole down to the brain. As of (b) (6) 2010, the patient was in the intensive care unit. Additional information has been requested, a follow-up report will be sent if additional information becomes available. See also manufacturer's report # 3007566237201003885

4/8/2010            3007566237-2010-03702
Event: one pt with pd and bilateral implants suffered a postoperative infection. Three days after surgery he developed fever, elevated c-reactive protein, mild intermittent confusion and a discrete left-sided hemiparesis. Signs of inflammation were seen along the right cerebral electrode. The electrode was removed, and samples for bacteriological culture were collected. The cultures were negative and the pt was treated presumptively with antibiotics, and had recovered fully within 1 month. However, after 3 months, the scar over the left electrode became purulent. The second electrode was removed and cultures demonstrated growth of coagulase-negative staphylococcus aureus, enterobacter aerogenes and alpha-hemolytic streptococcus. This pt did not suffer any permanent sequelae.

3/16/2010          3007566237-2010-03118
Event: two pd pts experienced infection/hardware removal resulting in three er visits. No further info was provided. See literature article with mfr report# 3007566237-2010-03105.

3/16/2010          3007566237-2010-03111
Event: five pd pts experienced infection resulting in seven er visits. No further info was provided. See literature article with mfr report #3007566237201003105.

3/16/2010          3007566237-2010-03048
Event: there were five events of infection (lead/ipg/wound). No further information was provided. See literature article with mfr report #3007566237201003026.

2/5/2010            3007566237-2010-01774
Reportable event: one pt presented with an infection of the scalp. The issue resolved after the system was explanted. The event was noted to occur before the first pre-protocol f/u visit. See literature article attached to mfr report# 3007566237201001765.

2/5/2010            3007566237-2010-01696
Reportable event: one pt had a lead removed due to infection. No pt outcome was reported.

2/5/2010            3007566237-2010-01723
Reported event: one pt experienced a postoperative infection requiring removal of all the hardware. The pt underwent re-insertion on the same side. See literature article mfr report # 3007566237201001699.


 

So, here's a list of 72 adverse events...most of which were filed by MedTronic staff...a number of which cite 'allergy', 'edema' (swelling), and other neural reactions consistent with brain swelling (confusion, gait disruption, death).  These events were reported to the FDA from July of 2011 to January of 2013 (I have not yet gone through the reports from January 2010 to July 2011...so this is about half of the total volume). 

Each account that says 'Literature' should also be read because it includes an adverse event report within the listing.  

If you need to find the FDA report number or filing date 
click here to open an Excel spreadsheet.    

Each report has its own number (you'll see it on the site).  I have numbered them here by sequence in my listing.  If you need to find the FDA report number or filing date click here to open an Excel spreadsheet.            

I did not include reports where leads broke or were bent.


1)  It was reported since internal neurostimulator (ins) replacement surgery in (b)(6), 2011 the patient started having gran-mal seizures with cyanosis at the same time on fridays. The patient was put on anticonvulsants to no avail. Patient outcome is unknown. If additional information is received, a follow up report will be sent.

2)  It was reported that the patient fell and her tremor symptoms returned. Patient outcome was not provided.

3)  It was reported that the patient experienced a loss of therapeutic effect. The patient's symptoms began to worsen over the past 10 months. There was no known accident or incident related to the event. Upon interrogation with the patient programmer it was discovered that the left implantable neurostimulator (ins) was powered off. Patient education regarding use of the patient programmer resolved the issue. The patient had an appointment with her physician scheduled for (b)(6) 2012. Additional information has been requested but was not available as of the date of this report.

4)  It was reported that implantable neurostimulator was explanted due to infection. The patient wanted to be reimplanted. Additional information has been requested but was not available as of the date of this report.  It was further reported that the serial number for this patient was a cardiac rhythm device. The patient had 2 different devices, and it was not known initially which device the infection was linked to. It was noted the patient is now ok.

5)  It was reported that the blue torque wrench clicked too late. The proximal contact of the electrode connection was damaged and unusable. Additional information received reported the event happened at the end of the lead implant procedure. The surgeon noticed the contact damage at the time the implantable neurostimulator (ins) was implanted a few days after the lead implant. The physician left the lead implanted and used the other contacts to achieve satisfying stimulation. There was no patient injury and the patient was fine.

6)  It was reported that the patient experienced a shocking sensation when laying on the side where the implantable neurostimulator was located. The patient was involved in a car accident in (b)(6) 2011 and began experiencing the shocking sensation following the accident. X-rays did not reveal anything remarkable and could not confirm breakage. There was no change in therapy and impedances were within normal limits. The physician offered to perform an investigational revision. The patient outcome was not known.

7)  It was reported that the patient took a large dose of pills in an attempted suicide. The patient was found by his family and taken to the hospital where he was recovering in the intensive care unit. The patient had been implanted for more than 6 months and had no signs of suicidal ideation prior to the event. The patient had been receiving a positive response from therapy in the subthalamic nucleus.  Additional information reported that it was not possible to establish a connection between the event and the therapy. No troubleshooting was performed and no devices were to be explanted. The patient outcome was "ok" with a positive response to the therapy and was to be under close follow-up by the clinic.

8)  It was reported that the neurostimulator was replaced with a prime cell neurostimulator and 2x4 pocket adaptor. During the first post operative investigation, the patient had inflammation of the skin. It was believed that the neurostimulator and adaptor were too large for the small, thin patient, which resulted in inflammation. The neurostimulator and adaptor were explanted and repositioned with new devices. The patient outcome was not known. Additional information has been requested but was unavailable as of the date of this report.  Additional information reported indicated that the device was explanted due to inflammation and that the device could not be used anymore. The reason it could not be used anymore was not provided. The surgeon thought that the inflammation of the skin was not device related. If additional information becomes available, a follow-up report will be sent.   Follow up information from the physician did not report any further problems with the patient.

9)  Lead model 3387 lot# unknown implanted (b)(6) 2012 explanted (b)(6) 2012. Analysis results were not available as of the date of this report. A follow up report will be submitted when analysis is complete. Event Description  It was reported that one contact on the lead did not work. The lead was replaced and there was no patient injury.

10)  Event Description  Additional information received reported that the patient had recovered. No interventions were necessary other than holding pressure during the surgery and observation in the hospital. Event Description  It was reported that during an implant the physician was tunneling in the neck with two extensions, when the tunneler/carrier nicked a jugular vein and caused a jugular bleed. The patient outcome was not reported. Additional information has been requested but was not available as of the date of this report.

11)  Event Description  It was reported that the pt's lead was replaced in 2009 due to a lead break. A second lead was found to be broken in (b)(6) 2011. The lead was replaced. No pt symptoms or outcome were reported. Additional info has been requested but was not available as of the date of this report.  Event Description  Additional information received reported that it was unknown what symptoms the patient experienced as a result of the lead break. The patient outcome was "good".

12)  Event Description  It was reported that during the implant procedure, the physician found the pt had signs of intracranial bleeding. The procedure was then stopped. If additional information is obtained, a follow up report will be sent.   Event Description  Additional information showed the patient recovered without sequela.

13)  It was reported that the lead was slightly curved at the distal end, between contact 0 and contact 1. When the surgeon checked the position of the lead with x-rays, it showed a deviation of approximately 6mm at the distal end of the lead. The surgeon tried to place the lead again, noticed the curve of the tip, and used a new lead. It was reported that there was no pt injury and the pt was fine.

14)  Analysis of the lead model 3587 lot unknown found no significant anomaly. The proximal end of the lead was ok and there were setscrew marks in the correct location. The lead conductors were ok. The outer insulation was cut 3. 1cm from the proximal end in suspected explant damage. There were suspected body fluids observed in the lead. The distal end of the lead was ok. Continuity was acceptable and there were no shorts between circuits.   It was reported that a lead revision took place (b)(6) 2011. Group impedances inter-operatively of the new lead were 198 ohm. The pt had a positive result after the revision.

15)  Analysis of the lead found the proximal end was stretched and insulation was broken underneath the #0 connector sleeve. No setscrew marks were observed. The conductors were stretched and conductor coils were crushed. The #0 and #1 conductors were broken at the #0 and #1 connector weld site from overstress/damage. The outer insulation was intact, and the distal end was ok. There were open circuits.  It was reported that the system had impedances of over 4,000 ohms on the lead, even when measured at 5 volts. Parkinson symptoms worsened over night. Intraoperative measurement of the extension and lead showed impedances over 4,000 ohms. The connection between the extension and the deep brain stimulation lead was opened and it was seen that the lead was damaged at the distal part. The lead was replaced with a lead of the same model, and the patient continued with deep brain stimulation therapy. Additional information was requested, but was not available as of the date of this report.

16)  It was reported the pt presented to the emergency room with severe eye/facial pain and swelling on the left side. There was also redness and swelling a the coronal incision site. A computed tomography (ct) scan of the head and lumbar puncture was performed and the results were "negative. " it was determined the pt had cellulitis and treatment was started with vancomycin. The pt improved with the vancomycin treatment, and the pt was switched to bactrim in preparation for discharge. Later the pt awoke from sleep with swollen eyes and a severe, throbbing headache. The pt also had retro-orbital pressure, which was new. The pt was put on iv vancomycin and ceftazidime. A magnetic resonance imaging (mri) was performed, and the result showed no intracranial abscess or infection. The pt was to be discharged on iv antibiotics.

17)  It was reported that during the implant procedure of four deep brain stimulation leads in a pediatric patient, it was not possible to insert the leads into the connectors of the two bifurcated extensions beyond the second connection in the extension. Forceps were used to hold both the leads and the extensions. It was the second contact on all four extension channels where the lead stopped. A blunt needle was passed through the extension channel to insure that there was no blockage and the needle appeared to pass through fine. The leads then were passed through again. This time the leads went through but still with some resistance. The leads and extensions were implanted. No impedance measurements were taken. At the time of this report, the patients system had not yet been switched on. Additional information has been requested, a follow-up report will be sent if additional information becomes available.   Manufacturer Narrative  Lead model 3389-28 lot# 0205400514 implanted: unknown explanted: unknown, lead model 3389-28 lot# 0205400513 implanted: unknown explanted: unknown, lead model 3389-28 lot# 0205398913 implanted: unknown explanted: unknown, lead model 3389-28 lot# 0205398001 implanted: unknown explanted: unknown.   Additional information received reported that the patient had been switched on with no issues to report. The patient was scheduled to be reviewed after one month.

18)  It was reported a (b)(6) man was with chronic lymphatic leukemia was treated for parkinson's disease with deep brain stimulation (dbs). It was also stated, the pt had undergone a pallidotomy in 1996. On (b)(6) 2004, the pt had dbs electrodes placed. It was stated, the pt became drowsy and uncooperative during surgery, and showed evidence of hemiparesis. This was followed by a decreased level of consciousness. A ct scan showed evidence of intraventricular bleeding. It was stated the pt's post-operative course was complicated by aspiration pneumonia, atrial fibrillation, and tension pneumothorax. The pt subsequently developed sepsis, which was treated with antibiotics. There was worsening of pulmonary function requiring mechanical ventilation. The pt expired. It was not clear from the info provided how long after the attempted implant procedure the pt expired. No further follow up will be attempted.

19)  It was reported the patient was hospitalized three days after implant with "weakness, rigidity, and inability to ambulate. " it was noted the patient still had significant "off-on" symptoms despite the deep brain stimulation system. No other interventions were reported. No further follow up is possible.

20)  It was reported that the patient had a deep brain stimulation system (dbs) implanted in 1995. In 2000, the patient had a second lead implanted. It was stated that the second lead implant procedure was "complicated by hemorrhage. " no other details were provided. No further follow up is possible.

21)  It was reported that the patient initially had "excellent response" to their deep brain stimulator after placement. In (b)(6) 2006, it was stated the patient had problems with "hallucinations and vivid dreams. " in (b)(6) 2007, testing showed a decline in the patient's cognitive function "consistent with mild dementia. " on (b)(6) 2007, the patient had their electrodes replaced as it was felt that their initial placement may have been suboptimal. It was not clear the revised electrode placement had any beneficial effect. No further follow up is possible regarding this patient.

22)  It was reported that the patient developed an infection their right lead, and the lead was removed. There was no outcome reported from the surgery. No further follow up is possible.

23)  It was reported that the surgeon used one of the blue torque wrenches to tighten the protective cap until the click. The tightening force was too much, and the distal contact of the lead was damaged. The lead was already implanted, and as they did not intent to use the damaged contact the lead was left in place. It was reported that there was no pt injury, and no pt outcome was provided. It was unclear which of the two leads were damaged. Refer to mfr report #6000153-2011-08227.  Analysis of wrench accessory serial # unknown determined there was no anomaly found with the wrench accessory.  

24)  It was reported that the patient underwent an implant for parkinson's. After he received the surgery he developed an infection and was oozing from his head. It was reported that the patient was still alive, but very ill. Additional information has been requested, but was not available as of the date of this report.

25)  It was reported that there was difficulty experienced in removing the guide tube. This was blamed on the tilting of the micropositioner as it left the x-y stage post that, thus, applied stress to the proximal end of the lead. The faulty electrode was not retained. A discontinuity was evident at the junction of the suspect contact #2 and the proximal polymer tubing, due to pulling on the lower lead while the contact ring was trapped by the guide tube. The same cause resulted in disordered coils visible inside the polymer, next to the #2 and #3 contact rings. Despite the pulling, the proximal and distal contacts remained in continuity. Additional information was requested but not available as of the date of this report. A follow-up report will be filed if additional information becomes available.

26)  It was reported that, during perioperative tunneling, the obturator that was supposed to hold the lead inside the extension passer, broke. The lead got stuck in the middle of the pt's neck. It was necessary to make an additional small incision in the pt's neck in order to move the lead into the correct location. The pt experienced no further issues, and there was no injury to the pt. The pt was "fine," and received good therapeutic effect from the stimulation.

27)  It was reported that the patient experienced a return of parkinson's symptoms, at a follow-up examination. X-rays confirmed that the leads were broken a few centimeters above the connection. Impedance readings were greater than 4,000 ohms, and also confirmed the break of the leads. It was noted that there was no injury to the patient. As of the date of this report, the patient received therapeutic effect on only one side, and was further treated with an increase in the dosage of medication. There was no device system revision planned. Additional information was requested but not available as of the date of this report. A follow-up report will be filed if additional information becomes available.

28)  Literature: deogaonkar m, nazzaro jules m, machado a, rezai a. Transient symptomatic, post-operative, non-infectious hypodensity around the deep brain stimulation (dbs) electrode. J clin neurosci. 2011:18(7);910-915. Doi: 10. 1016/j. Jocn. 2010. 11. 020. Summary: the authors discuss morphological characteristics of post-operative edema around a dbs lead in pts who presented between 2004 and 2009. Reportable event: one (b)(6) male presented to the emergency room complaining of a headache (b)(6) following gpi dbs implantation. Edema was found at the tip of the lead. The pt was given steroids for (b)(6) for this to resolve. See literature article with mfr report # 3007566237-2011-07706.  Manufacturer Narrative  (b)(4). It was not possible to ascertain specific device info from the article or to match the events reported with previously reported events.

29)  Literature: deogaonkar m, nazzaro jules m, machado a, rezai a. Transient symptomatic, post-operative, non-infectious hypodensity around the deep brain stimulation (dbs) electrode. J clin neurosci. 2011:18(7);910-915. Doi: 10. 1016/j. Jocn. 2010. 11. 020. Summary: the authors discuss morphological characteristics of post-operative edema around a dbs lead in pts who presented between 2004 and 2009. Reportable event: one (b)(6) left-handed male with a history of idiopathic parkinson's disease (pd) was admitted for placement of a right-sided stn electrode. Immediate post-operative ct head scans revealed minimal pneumocephalus with no parenchymal hemorrhage. The pt was discharged on postoperative day 2 with a normal exam. His second stage of surgery for implantation of the ipg was scheduled for a later date. Two weeks after discharge, the pt presented to the emergency room with a history of a single generalized convulsion followed by a brief loss of consciousness. On exam he was orientated and had no focal deficits. A ct brain scan revealed a large hypodense area (3cmx4cmx3cm) centered around the left dbs electrode primarily in the subcortical region and centrum semiovale that did not enhance on contrast administration. No local or systemic signs or symptoms of infection were present. He did not have any further episodes of seizure and was discharged home on anti-convulsant medication and a short course of oral steroids. A f/u ct scan after 1 week showed resolution of the edema. The pt was not given antibiotics. See literature article with mfr report # 3007566237201107706.

30)  Literature: smeding hmm, speelman jd, huizenga hm, schuuman pr, schmand b. Predictors of cognitive and psychosocial outcome after stn dbs in parkinson's disease. J neurol neurosurg psychiatry. 2011;82(7):754-760. Doi 10. 1136/jnnp. 2007. 140012. Summary: the authors examined predictors of cognitive decline and quality of life 1 year after bilateral subthalamic nucleus deep brain stimulation (stn dbs) in parkinson's disease (pd). A total of 105 pts were evaluated with a comprehensive neuropsychological assessment before and 12 months after surgery. A control group of 40 pd pts was included to control for effects of repeated testing and disease progression. Reportable event: the authors reported that normative comparisons method revealed that 38 out of the 105 stn pts showed cognitive decline, which is a pattern of test results that deviated significantly and in a negative direction from the control group. One stn pt had a pallidotomy during the f/u interval, two pts had a dislocated electrode, and two pts suffered a postoperative hemorrhage. After 12 months, six pts from the stn group were lost to f/u; two had an infection of the stimulator.  Manufacturer Narrative  (b)(4). The pt info provided is the average for all the pts. At this time, no add'l info was available, add'l info regarding the pts and devices has been requested. 

31)  Literature: torment mj, tomycz nd, coffman ka, kondziolka d, tyler-kabara ec. Bilateral subthalamic nucleus deep brain stimulation for dopa-responsive dystonia in a (b)(6) child: case report. J. Neusurg. Pediatr. 2011;7(6);650-653. Doi: 10. 3171/2011. 3. Peds10402. Summary: the authors present a case study of a medically intractable dopa-responsive dystonia in a (b)(6) boy whose condition significantly improved with bilateral subthalamic nucleus deep brain stimulation. This is a unique approach to tyrosine hydroxylase deficiency in a young pt. Reportable event: the pt presented at a 2-week f/u appointment post implantation with erythema around the right abdominal incision; this condition was treated with oral antibiotics. Both pulse generators were turned on at this appointment. The pt's dystonia had not significantly changed since the implantation procedure. The infection did not fully resolve, and thus the decision was made to remove the right pulse generator approx 6 weeks after the initial electrode and pulse generator placement. Before removal of the right sided pulse generator, the pt's dystonia had improved bilaterally and symmetrically. The generator was replaced 3 months later. Reinfection of the right-sided pulse generator site led to the generator's removal 2 months after its replacement. The intracranial electrode was left in place as there was no evidence of intracranial infection. Two months after re-removal of the pulse generator, the child presented with a right subgaleal fluid collection, and the right intracranial electrode was removed. Intravenous antibiotics were continued for 4 weeks. At the most recent clinical eval approx 14 months after the initial dbs electrode placement, the child showed marked yet somewhat asymmetrical improvement. On examination his dystonic movements were significantly improved on both the left and right sides, although with less dexterity on the right side. He can feed himself with finger foods. He can pull to stand. He can crawl with ease. His latency of response to questions and commands is markedly reduced. For the first time in his life, he can speak single words that are clear to his family and others. He is doubly continent. He consistently sleeps through the night, for up to 9-10 hours and had gained (b)(6) in 14 months.

32)  Reportable event: the authors report that following surgery, one pt did not have a follow-up assessment because of encephalopathy of unk original (presumed to be allergic) following electrode implantation which required removal of all dbs hardware a few days later (within the first 2 weeks). See literature article attached to mfr report # 3007566237201107448.

33)  Literature: kluger bm, foote kd, jacobson ce, okun ms, lessons learned from a large single center cohort of patients referred for dbs management. Parkinsonism relat disord. 2011;17(4):236-239. Www. Elsevier. Com/locate/parkreldis. Doi:10. 1016/j. Parkreldis. 2010. 05. 003. Summary: the authors prospectively collected data on 108 patients who had received dbs surgery for the treatment of parkinson's disease, essential tremor, dystonia or other, at an outside institution and who were referred for further management in order to uncover potential lessons to optimize dbs. Reportable event: ninety percent of patients reported at least one area of symptomatic dissatisfaction with the results of their dbs. Common issues included pre-operative misdiagnosis ((b)(6)), presence or exacerbation of symptoms not addressable by current dbs technology ((b)(6)), lead misplacement ((b)(6)), and need for medication ((b)(6)) or dbs programming ((b)(6)) optimization. Overall, (b)(6) of subjects had no improvement, (b)(6) slight improvement and (b)(6) large improvement after medical and/or surgical management.

34)  Reportable event: the authors reported that one pt (pt 2) had a family history of psychiatric illness such as major depression in four material relatives (all four completed suicides). Disease onset was at (b)(6) of age and prior to deep brain stimulation (dbs) the pt had three admissions to a psychiatric hosp; one admission lasted 18 months at age 30 following suicide attempt. Deep brain stimulation surgery occurred (b)(6) of age. The pt had one hosp admission, 3 months before death and responded to ect (five treatments). The pt was reported to have aggressive behavior warranting the use of restraints during this extended admission. The pt outcome to have extended periods of response and remission with temporary functional recovery (returned to work, but lost position due to a lack of functional integration into the workforce). The pt died at (b)(6), 35 months after dps implantation, by suicide. There was no evidence that the death was due to dbs device failure or changes in stimulation parameters. The source literature did not specify which device model was used. See literature article with mfr report# 3007566237-2011-07025.  Manufacturer Narrative (b)(4): aggressive behavior (y). (b)(4): it was not possible to ascertain specific device info from the article or to match the events reported with previously reported events. (b)(4). At this time no add'l info was available, add'l info regarding the pt and the device has been requested.

35)  Reportable event: the authors reported on a pt with a family history of psychiatric illness. The mother suffered from schizophrenia and the aunts had major depression but there were no completed suicides. Prior to dbs implantation, this pt was reported to have been admitted three times to the psychiatric hosp. One admission lasting 2 years occurred following a suicide attempt at (b)(6); this was the documented time of disease onset. At (b)(6), the pt received deep brain stimulation. The outcome for the pt was described as intermittent response and remission, but no functional recovery. The pt had three admissions at 3, 4 and 5 years post surgery; the longest admission lasted 2 months. The authors reported that this pt (pt 1) died 75 months after dbs implantation at the age of 55; this was an unconfirmed suicide. The authors indicated that there was no evidence that this was due to dbs device failure or changes in stimulation parameters. The source literature did not specify which device model was used.   Manufacturer Narrative  (b)(4). It was not possible to ascertain specific device info from the article or to match the events reported with previously reported events. At this time no add'l info was available, add'l info regarding the pt and the device has been requested.

36)  Reportable event: the authors reported that one pt had a hardware infection in the first 3 months after surgery. This complication was related to technical factors, including externalization of electrodes. The hardware was replaced without complication and with continuing clinical benefit. The source literature did not specify which device model was used. See literature article with mfr report# 3007566237-2011-07025.  Manufacturer Narrative  (b)(4). It was not possible to ascertain specific device info from the article or to match the events reported with previously reported events. At this time no add'l info was available, add'l info regarding the pt and the device has been requested. 

37)  It was reported that the patient was implanted with an activa rc on (b)(6) 2011 and everything was ok. The patient came to a consultation in (b)(6) 2011 / (b)(6) 2011 because she didn't feel well. The stimulator and impedances were ok, but the doctor saw an edema around the two electrodes and had a suspicion of infection. The doctor stopped stimulation, but could not confirm an infection. The doctor started a treatment with medrol and the patient seemed to improve, but the activa rc was not restarted. Additional information has been requested, but was not available as of the date of this report.

38)  It was reported that the patient was in a car accident and hit their head slightly. Since then their "thighs are constantly knotted into pain and their neck soft tissue was damaged and hurts all the time too. " it was reported that walking causes the patient severe pain. The patient visits their doctor "practically weekly" and she can get them moving, but the effect only lasts for about 4 hours. It was also reported that the patient's speech is slurred.

39)  It was reported that the patient experienced left hand paralysis, increase in blood pressure and drooping of the left eye (b)(6) an implantable neurostimulator replacement. The ins was on when these symptoms occurred. The hcp directed the patient to the emergency room in case the patient had a stroke. After admission to the emergency room, a ct scan had been performed and ruled out subdural hematoma. The patient had taken oral medications and now thought symptoms were more like dyskinesia instead of a stroke. The patient continued to have a slight droop on their left side.

40)  It was reported that the patient felt stimulation in the neck and head beginning about (b)(6) prior to report. It was noted that the lead-extension connection site was along the patient's neck. Therapy impedance measured 491 ohms (46ua). Low impedances (50 ohms) were reported. Specific impedance measurements were as follows: o&c 569 ohms, 1&c 965 ohms, 2&c 950 ohms, 3&c ohms, 0&1 850 ohms, 0&2 817 ohms, 0&3 50 ohms with 234 ua, 1&2 1077 ohms, 1&3 861 ohms, 2&3 828 ohms. The lead was replaced. The patient incurred no injury and was well.

41)  It was reported that at a follow-up appointment the pt reported a return of parkinson's symptoms. X-rays revealed a break in the lead, 2-3 cm from the extension connection site. Impedance >4,000ohm confirmed the break. There was conflicting info as to whether the lead had been replaced; however, evidence more strongly suggested a surgical intervention had not yet taken place. It was noted that no pt injury had occurred.

42)  It was reported that the pt never experienced therapeutic effects on the "second side. " reprogramming had not been successful. The pt acquired a second opinion and was told the lead was "too deep. " three of the 4 electrodes were non-functional. Further info reported that immediately following left side implant, the pt experienced severe pain and headache. The headaches continued in the weeks prior to implantation of the neurostimulator. After the neurostimulator was implanted, three of the 4 terminals or cases did not seem to be operating, and it was thought that the pt's brain may have had some swelling which was expected to recede in a "few weeks. " after a scan, the pt was told the device "placement was perfect. " the pt's speech continued to deteriorate. Multiple reprogramming sessions had resulted in the same symptoms: slurred speech, little to no tremor relief, and occasionally facial pulling. A second physician informed the pt the device was "too deep in his thalamus and that it would never work properly" or that the device may be malfunctioning. The physician informed the pt that the first three cases could not be used because they were "through the area they needed to be in and because of that placement-could only have adverse affects. " the physician recommended a replacement of the neurostimulator. The pt left the appointment with his device turned off. The pt received a letter from his physician on (b)(6) 2011 stating that the lead placement was correct and that the pt was being released from care. Post-operative mris showed lead were directly parallel and 11. 5mm from the mid-line in the std. Impedances were within normal limits. Additional info has been requested but was not available as of the date of this report.

43)  It was reported that the patient's tremor increased and the lead impedance was checked. All electrodes showed over 2000 ohms. No stimulation occurred when the electrode settings were changed. The hcp suspected a fracture and an x-ray was taken. The extension fracture was observed in the x-ray, the hcp decided to replace. The extension was replaced (b)(6) 2011.  Manufacturer Narrative  (b)(4): analysis of extension model 7482 serial number (b)(4) determined the # 0 and 3 conductors were broken at the weld. The conductor was broken at the distal end of the extension up to the transition point.

44)  It was reported that the torque wrench over-tightened screws, which resulted in stripped screws. The wrench had "too much torque/power," and was "too strong for the lead kit. " no further details were provided. The patient recovered without sequela.  Manufacturer Narrative  (b)(4). Results: used to refer to the torque wrench. Analysis of the torque wrench model unknown serial number unknown showed that no anomaly was found. The wrench was tested to 4. 3 ox/in. Torque specification = 4. 0 +/- 0. 5.

45)  It was reported that when the patient went into a (b)(6), he suddenly began to run around the store "banging into people and posts with the cart he was pushing". When his spouse got him outside the store, she turned the neurostimulator back on. At (b)(6) it was noted that he did not know "what a hamburger was or what to do with it". Since this time, the patient had been in and out of rehabilitation and was presently in a geriatric psychiatric unit. It was noted that the physician who implanted the device told the patient's family that the security system probably turned the stimulator on and off over a hundred times while he was in the store. Unable to follow
up with the contact information provided hence no additional information was obtained.

46)  It was reported that two leads were bent at the distal end. One lead was bent more than the other. The less bent lead was implanted

47)  A (b)(6) non-smoker with essential tremor had dbs implants. Twenty four hours post implant pt was comatose. Seven days post implant physicians determine: no stroke, no infection, and swelling in brain along path of leads. Pt (b)(6) was rendered paralyzed on the left side of his body and remains so one year post implant. He was also rendered incontinent and initially could not swallow or eat but after several months has been able to return to eating. Similar case documented in (b)(6) with dr (b)(6) md asst professor, (b)(6). All dates are approximate. Surgery was done last year in (b)(6). Implant was explanted 7 days later. Pt still paralyzed (left side), incontinent, bed ridden, on medicaid, cannot sit up.

48)  It was reported that the pt's physician suspected that the base of the lead underwent a "deflection" due to the shape of the pt's skull. Thus, the base of the lead was bent "a little," and the support clip did not fit the base of the lead. Another lead was used to complete the procedure. There was "no health hazard" to the pt and no further issue was reported.

49)  It was reported that there was a return of symptoms during the last four months. The hcp believed that it was due to the fact that only one lead had been implanted, so they decided to implant a new lead on the other side to obtain bilateral stimulation. At the moment of the procedure it was noticed that the lead already implanted presented an interruption of the conductions (they seemed to be broken) just before the connection with the extension. The impedances reported were>4000. Add'l info has been requested, but was not available as of the date of this report.

50)  Reportable event: the authors report on a (b)(6), right-handed, male (pt (b)(6)). His age of onset of pd was (b)(6). He underwent unilateral left stn-dbs surgery at the age of (b)(6) for motor function control of his right hand. The pt was "slightly dissatisfied" with his bladder condition before surgery and reported occasional urgency to urinate, difficulty with excreting urine, and urine leaking unwittingly while awake and asleep. Post-operatively, the pt was "satisfied" with his bladder condition. He reported having significant, symmetric sweating problems pre-operatively that worsened during the day and was worse when "off" medication. Post-operatively, he did not experience any sweating problems. His bilateral sweating problem resolved completely even with unilateral stn stimulation. The pt required a revision to replace the left stn electrode due to a lead fracture, his sweating problem resumed until the electrode was replaced and the pulse generator was turned back on, at which time the sweating problem again resolved immediately.  Manufacturer Narrative  (b)(4). It was not possible to ascertain specific device info from the article or to match the events reported with previously reported events. At this time, no add'l info was available, add'l info regarding the pt, event, interventions and outcome has been requested.

51)  Reportable event: during the first 6 months after the operation, two patients had their stimulation electrodes removed due to an infection and one pt committed suicide.

52)  It was reported that the pt visited the physician due to the return of symptoms. The pt was reprogrammed and an x-ray was performed. There was "some breakage" found at the proximal end of the lead. An explant and replacement of the lead was performed during the week of (b)(6) 2011. The pt, then, received "proper" therapy. There was no injury to the pt.

53)  It was reported that the physician had "multiple failures" of the lead cap when attaching and/or detaching it from the proximal end of the lead, between the first- and second-stage procedures. The metal housing for the grub screw rotated within the silicon body of the lead cap, and was too small to hold effectively. This resulted in "obvious damage" to the lead on several occasions. The leads were not replaced. There was no injury to the pt. The pt recovered without sequela. A follow-up report will be filed if additional info becomes available.

54)  Summary: the authors report on 13 patients who received deep brain stimulation (dbs) from (b)(6) 2007 to (b)(6) 2009; 12 patients underwent bilateral stimulation of the subthalamic nucleus and 1 pt underwent unilateral stimulation. Mean age was 62 (48-68); there were 9 male patients and 4 female patients. Twelve of the 13 patients presented complications, with a total of 27 complications. A complication was defined as "any new symptom or escalation of a preexisting symptom". Complications were classified as severe if they were disabling, interfered with activities of daily living in a relevant manner, if urgent treatment was needed, if hospitalization or surgery was required,or if it was life threatening or led to death. A complication was classified as moderate if it interfered with activities of daily living or if any treatment was needed. A complication was classified as mild if it was tolerated, did not interfere, or only slightly interfered with activities of daily living or did not require treatment. Reportable event: one pt suffered intraoperative intracerebral hemorrhage, which was severe and symptomatic but evolved without secondary complications. This pt was reduced to unilateral stimulation, on the opposite side of the hematoma. At 6 months, this intracranial hemorrhaging had progressed without secondary motor complications.

55)  Literature: calado a, semedo c, dias m, et al. [subthalamic nucleus deep brain stimulation for parkinson disease: initial experience from centro hospitalar de lisboa central]. Sinapse. 2010;10(2):5-10. Summary: the authors report on 13 patients who received deep brain stimulation (dbs) from (b)(6) 2007 to (b)(6) 2009; 12 patients underwent bilateral stimulation of the subthalamic nucleus and 1 pt underwent unilateral stimulation. Mean age was 62 (48-68); there were 9 male patients and 4 female patients. Twelve of the 13 patients presented complications, with a total of 27 complications. A complication was defined as "any new symptom or escalation of a preexisting symptom". Complications were classified as severe if they were disabling, interfered with activities of daily living in a relevant manner, if urgent treatment was needed, if hospitalization or surgery was required,or if it was life threatening or led to death. A complication was classified as moderate if it interfered with activities of daily living or if any treatment was needed. A complication was classified as mild if it was tolerated, did not interfere, or only slightly interfered with activities of daily living or did not require treatment. Reportable event: one pt suffered intraoperative intracerebral hemorrhage, which was severe and symptomatic but evolved without secondary complications. This pt was reduced to unilateral stimulation, on the opposite side of the hematoma. At 6 months, this intracranial hemorrhaging had progressed without secondary motor complications.   Manufacturer Narrative  (b)(4). It was not possible to ascertain specific device info from the article or to match the events reported with previously reported events. It is also possible several events occurred in one pt. The pt info provided in section a is the average for all the patients. At this time no add'l info was available.

56)  Reportable event: one patient died due to sudden onset of acute mesenteric ischemia (confirmed intraoperatively) on the 18th day after surgery. In this case, the authors report that the cause of death did not seem to be clearly related to the neurosurgery. See literature article with mfr report# 3007566237-2011-05122. It was not possible to ascertain specific device information from the article or to match the events reported with previously reported events. It is also possible several events occurred in one patient. The patient information provided in section a is the average for all the patients. At this time, no additional information was available.

57)  The health care professional complained of multiple instances of the extension locking mechanism not locating positively and springing open. It was not clear if the mechanism had locked or not. The extension was able to be implanted. The patient was not injured and recovered without sequela. A follow-up report will be sent if additional information becomes available.

58)  It was reported the pt's obsessive compulsive disorder symptoms were deteriorating. The pt had anxiety increase, panic attacks, and withdrawal symptoms due to tapering and stopping serotonin-norepinephrine reuptake inhibitor (snri) treatment. The event resulted in in-patient hospitalization. The pt stopped taking venlafaxine and started taking lorazepam. The event was ongoing. About (b)(6) later the pt had obsessions, compulsions, and anxiety due to worsening or exacerbation of the pt's ocd. The event resulted in in-patient hospitalization. The device was reprogrammed, and the pt recovered without sequelae.

59)  Summary: this article discusses a case of a (b)(6) male pt with an 8-year history of obsessive-compulsive disorder (ocd) who experienced hypomania and hypersexuality during bilateral deep brain stimulation (dbs). One-sided stimulation did not induce this effect. Event: the pt experienced mild euphoria and decreased obsessive thoughts while bilateral dbs was turned on at 8v, which dissipated when stimulation was turned off. Two weeks after this test, stimulation was set to 3v. After three weeks of stimulation, the pt had energy improvement, a decreased need for sleep, increased sexual desire and frequent sexual thoughts, although the ocd symptoms persisted. The pt was a christian and was uncomfortable with the increased sexual drive. Because of the persistent symptoms, stimulation was turned up to 4v and at a two week f/u, the pt had quick mood changes, an unstoppable sexual desire and was quicker to anger, but the ocd symptoms still persisted. Stimulation was increased to 4. 5v. A few days later, the pt experienced severe suicidal ideation due to the persistent symptoms and hypersexuality. The stimulation was decreased to 1v, and the hypersexuality had subsided by the time of the next two week f/u. The pt was depressed, however, because the ocd condition remained the same as before surgery.

60)  Literature: lai sc, jung sm, grattan-smith p, et al. Neuronal intranuclear inclusion disease: two cases of dopa-responsive juvenile parkinsonism with drug-induced dyskinesia. Mov disord. Jul 15 2010;25(9):1274-1279. Summary: this article described two children with neuronal intranuclear inclusion disease (niid) who presented with dopa-responsive juvenile parkinsonism, and who had initial good levodopa response that was complicated by disabling dopa-induced dyskinesia. Both patients died within 10 years of symptom onset. The article discussed differential diagnosis of clinical symptoms and neuropathological finds. Event: one female who underwent subthalamic nucleus deep brain stimulation (dbs) experienced a return of symptoms 6 months post surgery after initial improvement of tremor and bradykinesia, and depression and labile emotion one year after surgery. Subsequently, the patient experienced recurrent infections and died due to aspiration pneumonia approximately two years after surgery. The authors indicate that the patient's widespread pathology probably accounted for the lack of sustained response to dbs. The patient's motor symptoms prior to surgery had progressed rapidly and her cognitive function had declined. The patient had demonstrated severe gait ataxia, dysarthria, dysphagia, saccadic pursuit and nystagmus, blepharospasm and focal dystonia in distal limbs.  Manufacturer Narrative  (b)(4). It was not possible to ascertain specific device information from the article or to match the events reported with previously reported events. At this time no additional information was available, additional information has been requested. A copy of this article can be accessed at www. Interscience. Wiley. Com.

61)  Literature: dam-hieu p, magro e, seizeur r, simon a, quinio b. Cervical cord compression due to delayed scarring around epidural electrodes used in spinal cord stimulation. J neurosurg spine. Apr 2010;12(4):409-412. Summary: this article discusses two cases of cervical spinal cord compression due to dense scar tissue formation around epidural electrodes implanted for spinal cord stimulation (scs) several years after implantation. Prior to the myelopathy, the pt experienced a tolerance phenomenon. Reportable event: a (b)(6) male pt who was implanted in 2001 at the c4-5 level with scs for severe type 1 complex regional pain syndrome (crps) of the right forearm and hand experienced motor deficit in the left interior limb and dysthesias and hypethesia of the left hemibody at the end of 2006. Examination of the cerebrospinal fluid revealed an elevated protein level and normal cytology. After implant, the pt had had a significant decrease in pain levels and trophic disorders but required progressive increase in the intensity of stimulation levels 6 months after surgery due to the tolerance effect. Mri imaging revealed compression of the cervical spinal cord by the epidural electrode. The neurological disorders continued to progress, and the electrode and stimulator subsequently were removed. During surgery, a 9mm thick back of scar tissue between the electrode surface and the posterior aspect of the dura meter was found. The scar tissue was pulled easily off the dura mater. Immediately following surgery, the neurological disorders started to regress and completely disappeared within 3 months. However, the crps symptoms returned. See mfr report #3007566237201104742 for a copy of the literature article.  Manufacturer Narrative  (b)(4). It was not possible to ascertain specific device info from the article or to match the events reported with previously reported events. Additional info has been requested. A copy of the literature article is accessible at: (b)(4).

62)  The pt visited her health care professional (hcp) because she was not feeling well and sensed her implantable neurostimulator (ins) was turned off. The pt was admitted to the emergency room and was diagnosed with a heart attack. The pt subsequently died in the hospital. The hcp was concerned about the timing of the ins issues and the heart attack. Additional info has been requested, a follow-up report will be sent if add'l info becomes available.

63)  Literature: tsai hc, chen sy, tsai st, hung hy, chang ch. Hypomania following bilateral ventral capsule stimulation in a pt with refractory obsessive-compulsive disorder. Biol psychiatry. Jul 15 2010;68(2):e7-8. Summary: this article describes a case of hypomania following deep brain stimulation of the bilateral ventral capsule near the nucleus accumbens (nac) in a (b)(6) male pt with refractory obsessive-compulsive disorder (ocd). Prior to surgery, the pt's score on the yale-brown obsessive-compulsive disorder scale was 39 and the pt was taking sodium valproate, sertraline, clozapine, and lorazepine. The medications remained constant after surgery. Compulsive behavior included hand washing and spitting. Event: the pt became euphoric when stimulation was increased to 4 v to relieve the ocd symptoms which still persisted one month stimulation was started. The pt did not sleep the whole night and was hyperactive and restless. For two weeks these symptoms improved, but the pt became irritable. When told to stop hand washing, the pt became furious and broke a mirror with the right hand necessitating a trip to the er for a fractured wrist. Due to the rapid deterioration of mood and the aggressive behavior, the pt was admitted to the hospital for a suspected hypomaniac episode. The pt's medication was increased and stimulation was turned off. The hypomaniac symptoms decreased gradually within one week. Brief stimulation induced mild euphoria and decreased obsessive thoughts. A positron emission tomography showed significant activation of the nac ventral striatum during stimulation. The original stimulation settings were then maintained following the wishes of the pt's family. Two months later, symptoms still persisted. The pt then underwent revision surgery in which the stimulation sites were moved to more distal placements. The ocd symptoms persisted, but hypomaniac symptoms did not recur.  Manufacturer Narrative  (b)(4). It was not possible to ascertain specific device info from the article or to match the events reported with previously reported events. At this time no additional info was available, additional info has been requested. A copy of this article can be obtained at www. Sobp. Org/journal.

64)  The patient was not receiving effective therapy. High impedances were measured. Radiographs indicated that the lead had fractured. The lead was explanted and replaced. The patient regained therapy after the lead was replaced. A follow-up report will be sent if additional information becomes available.  Manufacturer Narrative  (b)(4). The lead has been returned to the manufacturer for analysis. A follow-up report will be sent when the analysis is complete.

65)  Literature: bhatia s, zhang k, oh m, angie c, whiting d. Infections and hardware salvage after deep brain stimulation surgery: a single-catheter study and review of the literature. Stereotact funct neurosurg. 2010;88(3):147-155. Summary: this article described the incidence and management of infections in pts who rec'd deep brain stimulation (dbs) between (b)(6) 1997 and (b)(6) 2008 in a single institution over the past 11 yrs. A database of 270 pts with 484 implants was used, with 56 unilateral and 214 bilateral implants. All pts were followed-up for at least 6 months. Infection was diagnosed by either adequate clinical or positive microbiological evidence. Incidence, clinical characteristics and management of infections were analyzed. The overall infection rate was found to be 9. 3% by pts (n=25) and 6. 8% by episode/implants (n=33). The median time of infection after implant was 64 days. Comorbidities were more frequent in infected pts. Infection rates decreased from 14. 3% to 4. 9% after (b)(6) 2003 when the surgeons began a low profile burr hole cap and extension and in the second stage of the surgery started tunneling in a manner that allowed connection of the extension wire with the electrode w/o reopening the previous frontal incision. Overall there were 19 frontal burr hole, 11 connector site and 14 internal pulse generator (ipg) site infections. Chronic skin erosion was the chief cause of hardware-related infection. Reportable event: a (b)(6) male pt with parkinson's disease and hypertension experienced a deep infection with purulent drainage in both frontal burr hole incisions and the right chest ipg site region 43 days after implant. A culture came back positive for staphylococcus aureus. The pt underwent incision and debridement with removal of both systems and was treated with intravenous antibiotics. Antibiotic treatment continued for at least 6 weeks. A weekly f/u was undertaken with examination of the wound until it was completely healed. See mfr report #3007566237-2011-04171 for a copy of the literature article. See mfr report #3007566237-2011-04391 regarding the pt's other dbs system. Manufacturer Narrative  (b)(4). It was not possible to ascertain specific device info from the article or to match the events reported with previously reported events. At this time no add'l info was available, add'l info has been requested. A copy of this article can be obtained at www. Karger. Com/sfn. Doi: 10. 1159/000303528.

66)  Literature: coffey mj, chou kl, patil pg, catatonia during deep brain stimulator implantation complicated by intracranial hemorrhage. Mov disord. Jun 15 2010; 25(8): 1097-1098. Summary: this article describes a parkinson's disease (pd) patient who developed catatonia during deep brain stimulation (dbs) surgery complicated by intracranial hemorrhage. Event: a (b)(6) female patient with levodopa-responsive pd for (b)(6) and a history of nonmelancholic depression underwent surgical placement of dbs electrodes into each subthalamic nucleus. During the procedure, the patient experienced mild hypertension which was controlled with low doses of metoprolol. Prior to electrode placement, the patient spoke when asked questions and complained about intermittent left arm pain. During electrode placement, the patient gradually developed dystonic flexion posturing of the left arm and intermittent flexion of the right arm and left leg, and was mute when asked questions. The patient had gegenhalten in both arms and eyelids upon passive manipulation. There was no motor weakness. The patient also displayed a protruding grimace (schnauzkrampf), bilateral grasp reflexes and mitgehen in the right arm. Lorazepam 2 mg was given intravenously and the patient's bush-francis catatonia rating scale score decreased from 24 to 10 after four minutes. The patient had decreased rigidity and the grimace and mitgehen disappeared. A ct scan revealed an acute intraparenchymal hematoma in the right frontal lobe with a small amount of associated extra-axial blood. There was mild adjacent mass effect with effacement of the cerebral sulci and frontal horn of the right lateral ventricle with subfalcine herniation and associated mild midline shift to the left. The patient was transferred to neurosurgical intensive care where her bush-francis score was 28 four hours after surgery. The stupor, rigidity, negativism, grimacing, and mitgehen had returned. The patient was managed for 10 days without change and thereafter transferred to a subacute care facility closer to home. The patient's subsequent course was unknown by the authors.  Manufacturer Narrative (b)(4). It was not possible to ascertain specific device information from the article or to match the events reported with previously reported events. At this time, no additional information was available, additional information has been requested. (b)(4). 

67)  Reportable event: a (b)(6) male, pt, with parkinson's disease and coronary artery disease experienced a deep intracranial infection (meningitis) 1 day after implant. A culture came back negative. The pt received intravenous antibiotics. See mmfr report #3007566237201104171 for a copy of the literature article. See mfr report #3007566237201104257 regarding the pt's other dbs system.

68)  Reportable event: a (b)(6) female, pt, with cerebellar tremor, cerebellar degeneration, and peptic ulcer disease experienced a deep infection with purulent drainage in the right frontal burr hole incision 22 days after implant. A culture came back positive for (b)(6) and (b)(6). The pt underwent incision and debridement with right lead removal and was treated with intravenous antibiotics. Antibiotics were continued for at least 6 weeks. A weekly f/u was undertaken with examination of the wound until it was completely healed.

69)  Event: one pt experienced erosion of the incision that was treated with incision and debridement. The pt also experienced overt infection and the system was removed prior to the 2006 follow-up. The timing of these events was unclear. One pt experienced erosion of the incision that was treated with incision and debridement. The pt also experienced overt infection and the system was removed between the 2006 and 2008 follow-ups. The timing of these events was unclear. One pt had the system removed due to infection. The system was explanted and reimplanted several months later. Four pts underwent replacement of the leads due to lead fracture. One pt underwent replacement of the extension due to "malfunction. " it was not possible to ascertain specific device info from the article or to match the events reported with previously reported events. The pt info provided in section a is the average for all the pts. At this time no additional info was available, additional info regarding the pt, event, interventions and outcome has been requested.

70)  Event: following the second stage of the stn-dbs surgery during which the stimulator was implanted and during which the pt had mechanical ventilation, the pt's trachea was extubated and the pt was moved to the icu. On the fifth post-operative day, 40 mg of enoxaparin was administered to prevent deep vein thrombosis. The pt became unresponsive within a few hours of administration. The pt was reintubated and taken for a ct scan which revealed an intracerebral hematoma in the left basal ganglion and left fronto-parietal region with midline shift and perilesional edema. Prothrombin time and activated partial thromboplastin time were prolonged with a normal platelet count. Enoxaparin was discontinued and six units of fresh frozen plasma were transfused, while mechanical ventilation was continued. The pt's coagulation status returned to normal within the next four days, and there was an improvement in neurological status. The hematoma had resolved and was not expanding so no evacuation was performed. The pt then developed ventilator-associated pneumonia and sepsis due to methicillin-resistant staphylococcus aureus on post-operative day 25. It was not possible to ascertain specific device info from the article or to match the events reported with previously reported events. At this time, no additional info was available. Additional info has been requested.

71)  Literature: johnson rd, qadri sr, joint c, moir l, green al, aziz tz. Perioperative seizures following deep brain stimulation in patients with multiple sclerosis. Br j neurosurg. Jun 2010;24(3):289-290. Summary: this article discussed the occurrence of seizures during the peri-operative period in two thalamic deep brain stimulation (dbs) patients with histories of tremor and multiple sclerosis (ms). Event: a (b)(6) female with a history of postural and intention tremor predominately in the right arm and a 16 year history of ms, experienced a ten minute prolonged complex-partial seizure with jerking of the right side of the face as well as clonic movements of the right arm and leg five days after the implantation of left thalamic leads that were initially left externalized. The seizure was stopped by 4 mg of lorazepam, after which the patient had markedly reduced consciousness and required intubation and ventilation. An emergency ct head scan ruled out any hematomas. An electroencephalogram (eeg) showed evidence of post-ictal slowing, most pronounced over the left hemisphere. The patient was given phenytoin and was extubated within 24 hours. A right-sided todd's paresis resolved over the next three days and the dbs wires were internalized two weeks following the initial surgery without further complications. Phenytoin was changed to sodium valproate, which was discontinued three months post-operatively. The patient had no more seizure episodes. See mfr. Report #3007566237-2011-03977 regarding other patient mentioned in the article and for a copy of the article.  Manufacturer Narrative  (b)(4). It was not possible to ascertain specific device information from the article or to match the events reported with previously reported events. At this time no additional information was available, additional information has been requested.

72)  Event: a (b)(6) female patient with a history of intention tremor of the hands, ms and a right thalamotomy, experienced erosion of the lead through the skin four years after left thalamic dbs implantation that provided relief of the right sided tremor. The lead was removed. A repeat left thalamic dbs was inserted five years after the first implant, after which the patient experienced a one-minute grand mal seizure 24 hours post-operatively. The patient was post-ictal for several minutes, was given phenytoin, and recovered well within 20 minutes with no further neurological deficits. A ct head scan ruled out hematomas. Phenytoin was discontinued and the patient did not suffer any more seizures. See mfr. Report #3007566237-2011-03976 regarding the other patient mentioned in the article.

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