I acknowledge your recent communications with the Food and Drug Administration.
Please be advised that the response you received to your request under the Freedom of Information Act (FOIA) does not mean that there are no documents in existence regarding this matter, it means only that there are no documents that can be disclosed to you under the provisions of FOIA. As I previously explained in my March 23, 2012 email, there are substantial constraints around information that can and cannot be disclosed by the agency.
The letter you received provided information about how to appeal the determination you received in response to your request.
David S. Buckles, PhD, FACC
"About how long will I have to wait before I can go in to see the major?"
"Just until he goes out to lunch," Sergeant Towser replied. "Then you can go right in."
"But he won't be in there then. Will he?"
"No, sir. Major Major won't be back in his office until after lunch."
"I see," Appleby decided uncertainly.
This page is about my father-in-law, Ed, who had DBS surgery for essential tremor on April 9, 2010. Unfortunately, he had an allergic reaction in his brain to the leads which left him paralyzed and bed-ridden to this day.
Ed asked me to try to raise the awareness to the risks of allergic reactions within the brain to the Medtronic Activa Neurostimulator leads (a reaction that has been documented in this study to occur in about 11% of cases).
If you are a loved one are considering having this surgery (which can have wonderful outcomes) please read this page and ask your doctors to read it.
So far, over 39,000 people have visited this site.
WARNING: If you, or a loved one, is considering having DBS surgery (implantation of neurostimulator leads into the brain) for essential tremor, Parkinson's disease, depression, or dystonia please read about my father-in-law's case and the side effects he experienced before deciding to have this 'elective' surgery....and, if you do decide to have it, make CERTAIN that you:
1) have a skin test prior to surgery to test for allergies,
2) if you are over 70 years of age that you only allow them to insert the lead into only one side of your brain upon initial surgery, and
3) that you are kept in the hospital for at least two to three days (or longer) after implantation so that you can be monitored for potential swelling in the brain (brain edema).
If you let your doctors send you home the day of, or the day after, implantation(which is the current practice standard in the US) and if your brain reacts to the leads you will most likely not have time to get back to the hospital and have the leads removed before significant brain damage has occurred.
Tell your doctor that your brain is worth the extra couple of days for monitoring.
Your doctor may reply that such precautions are 'extreme'. In my view, allergy tests are like smoke detectors....they are not expensive, sometimes they go off when they shouldn't (in medicine what is called a 'false positive'), and based on the number of house fires (in this case 'allergic reactions'), they are the most 'expensive' safety device to society because they are in so many homes that never catch fire. Still, they are required because when they do go off and there is smoke or a fire, they are the best means for saving your life and the lives of your loved ones. Is having a smoke detector 'extreme'? I don't think so.
The other two precautions come from the responses I have received from neurosurgeons in other countries (England and Norway). One would hope that the safety precautions of US medicine are not 'less than' those in other developed countries.
Ed's surgery was on April 9, 2010. A full two years after his 'adverse event' his case has neither been published in the medical literature nor, does it appear that it has been reported correctly to the FDA.
In this age of 'instant this' and 'global that' ... neurosurgeons throughout the United States tell me that they 'have never heard of' an allergic reaction to the Medtronic Activa Neurostimulator leads (even though such reactions have been documented in the medical literature to occur at a rate of over 10%).
Is Medtronic telling doctors about this? It does not appear to be so. (ASK YOUR DOCTOR!) In fact, it appears that Medtronic either did not report Ed's case to the FDA or they intentionally 'falsified' it so that it made it look like his 'allergic reaction' was due to an 'infection'. Put simply...if there was 'infection' it was the surgeon's fault. If there was not infection, then there might be a problem with the device. So, if the report that the FDA has from Medtronic is indeed 'Ed's'...it appears at this point that Medtronic reported that Ed had an 'infection' when, in fact, the medical record clearly states there was no sign of infection.
The FDA is investigating the matter as we speak.
April 18, 2012 April 30, 2012 we know this:
First: The FDA is investigating whether or not Ed's case was correctly reported as an adverse event. At present, it appears, per the FDA that Ed's case was either not reported to the FDA or was reported with 'accomodating' errors which ascribe the problem to 'infection at the burr hole' when Ed's medical record clearly states that there was no sign of infection.
Second: Ed's case HAS NOT TO DATE BEEN PUBLISHED IN ANY MEDICAL JOURNAL and the medical provider who performed the surgery informed us over two months ago that we (Ed's family) would have to pay for any and all associated medical tests (eg, MRIs) or they would not publish the study.
Third: Medicare has opened a 'quality of care' investigation into Ed's case.
As you read this page you'll come to see how easy it is for 'inconvenient truths' to not see the light of day.
So here I am with a GoDaddy website trying to address a public health issue.
Dateline April 8, 2012
Today I received this letter which indicates that the NC DHHS (in response to the US DHHS) is opening an investigation (which will be completed in 45 days) as to whether or not NC Baptist Hospital violated any 'Medicare Conditions of Participation' related to quality of care.
To be clear, I did not contact the US DHHS concerning quality of care issues. The investigation underway by the NC DHHS is a result of the decision made by the US DHHS, not me. (Click here to see US DHHS letter authorizing investigation.)
All this leads me to a seven simple questions: 1) Does the system of expecting medical professionals and medical device companies to 'self report' to the FDA actually work? 2) Do any medical professionals read FDA adverse event reports? 3) Why did the NIH take so long to respond to my initial inquiry? 4) Why has Ed's case not been published in the medical literature? 5) Was his case correctly reported? 6) Will the FDA enforce the law? and finally, 7) How is it that a citizen must resort to using a 'GoDaddy' web site to 'smoke out' the players holding the cards? When I first raised this issue to the FDA and the NIH I thought that was all it would take. Ha. Some people say that 'they are all in it together'. I hold on to the hope that that is not true.
And finally, should it really take TWO YEARS?
In a recent visit with Ed he asked me to find a song for him called 'Slow Poke'. I trust the irony is not lost.
Dateline: March 23, 2012
The FDA informed me today that it is opening up an investigation as to whether or not Ed's adverse event was reported and reported correctly.
The FDA has been very responsive and professional in their replies to me and I commend them for that.
Dateline: March 22, 2012
In response to my inquiries to the FDA as to whether or not Ed's 'adverse event' was reported, the FDA provided two 'adverse event' reports filed by Medtronic. The date of surgery on the report is not the date of Ed's surgery. The report cites 'infection from burr hole into brain'...yet Ed did not have any infection. The first report states that additional information will be provided. The second report is an identical copy of the first report. All this means that either Ed's case was not reported or it was reported with inaccuracies. Either way, it's a problem. See 'Was the FDA Notified?' page for more details.
In addition the US Department of Health and Human Services sent this letter indicating that they have opened up a 'quality of care' Medicare Condition of Participation investigation.
Dateline: March 19, 2012
In case you are new to this site, this is a brief summary of where things stand at this point. In April of 2010 my father-in-law, Ed, had DBS surgery for essential tremor.
He never made it home due to an allergic reaction in his brain to the DBS leads.
He now is paralyzed and is cared for in a SNF. We were told this was 'unheard of' and that it was a 'one in a hundred thousand' case.
Medtronic was informed of the event and at least one of the leads was sent to them for analysis. That analysis showed no 'abnormalities'.
In July of 2011 I reported the adverse event to the FDA through MAUDE.
I also contacted the NIH and directly emailed clinical trial directors doing DBS research to alert them to this risk. Some of those clinical trial directors replied (to their great credit) stating that they had never heard of such an outcome. During this time I also became aware of Dr. Kraakevik's report concerning a documented case of allergic reaction to the leads.
In response to my inquiry, the NIH informed me in August of 2011 that a letter would be 'forthcoming' addressing the allergic reaction risk issue.
In December 2011 I ask Senator Richard Burr for assistance and his office intervenes.
In February of 2012 I receive this letter NIH Response which states that the medical literature has little documentation of allergic reactions and that further research is planned.
Shortly thereafter, a renowned physician with interest in this matter finds this study from August 2011 which documents allergic reactions in the brain in response to the DBS leads.
The study (detailed below) documents a 10 to 11 percent incidence allergic swelling in the brain in response to the DBS leads.
Interestingly, this study was not included in the NIH review nor has my father-in-law's case been published in the medical literature.
I asked the FDA if either Wake Forest Baptist Medical or Medtronic had reported 'Ed's' adverse event to the FDA. On March, 6 2012 the FDA provided me this information. They could not say if it was Ed's: FDA Report
Via this website I asked Medtronic to publicly reply (to firstname.lastname@example.org) as to whether or not this was their filing on Ed's case. No response has been received to this date. In addition, I emailed "Catie Owen" at Medtronic to ask the same. Again, no response.
On March 4, 2012 I mailed a letter to the US Department of Health and Human Services to ask if the 'adverse event' had been reported. Their response arrived on March 19, 2012 (who says that the Government is not efficient!) and a copy of it can be found here.
As of this date (3.19.12) it is my hope and understanding that this issue is being discussed by the medical community.
In the meantime, we are hoping to get my father-in-law's case published in the medical literature but Wake Forest Baptist Medical is telling us that we will have to pay for all the tests and expenses.
I emailed Medtronic to ask if they will pay for the tests but they declined.
When asked about who should bear the financial liability for the tests necessary for publication, the NIH responded, 'No comment'.
Dateline: February 22, 2012
A recent study by Englot, Glastonbury, and Larson at UCSF looked at the incidence of 'inflammatory response' in the brain along the path of the DBS leads. Interest in this issue stemmed from the clinicians having noted '... several instances of abnormal T2-weighted signal hyperintensity surrounding DBS leads on postoperative MRI that are not associated with hemorrhage or infection'. In other words...a potential allergic reaction.
To investigate, they pulled charts on 133 patients who had undergone DBS surgery over a nine year period and looked at their MRIs for this marker of 'inflammatory response." (T2-weighted signal hyperintensity characteristics are, according to the authors, '...most consistent with vasogenic edema, possibly representing an inflammatory response').
They found that when there was a T2 signal abnormality it was typically 'unilateral' (meaning only one lead in the brain showed evidence of inflammatory response). Of the 133 patients they found 15 instances of T2 signal hyperintensity surrounding the DBS leads. If, as stated, this finding was 'typically unilateral' that means that of the 133 patients, 15 or so had T2 signal hyperintensity since only one lead 'typically' showed reaction. So, of the 133, 15 people or so had T2 markers for 'inflammatory response'. This is an 11.3% incidence of 'inflammatory response'.
The study concludes: 'Further research will be needed to explain this curious neuroimaging finding, and to rule out cause for clinical concern.'
It further adds:
Hardware-related neurotoxicity is another possibility warranting exploration. A Medtronic product manual warns that polyurethane lead components may possess neurotoxic properties  , although a recent study by St.Jude/ANS manufacturers did not reveal adverse effects in either an animal model or in vitro neuronal preparation exposed to these components  . Further study of potential neurotoxic effects of DBS hardware and of the clinical correlates related to abnormal MRI signals in postoperative DBS patients is warranted.When I informed Medtronic of my father-in-law's allergic reaction to the DBS leads here is the response I received:
This site is sponsored by the son-in-law of a man who 'strapped himself in' and had DBS surgery for essential tremor. He had an allergic reaction in his brain to the leads which left him paralyzed and bed ridden. Since August of 2011 I have been waiting to hear from the NIH how it would protect future patients from this risk. Although they said a 'response was being prepared'...to date no response has been received.
(This next paragraph is written in order to have this page listed on the first couple of pages on a Google search...hence the 'odd writing'.)
DBS surgery has many risks and complications. Deep Brain Stimulation surgery using Medtronic Activa Neurostimulators can result in serious DBS surgery side effects. If you are considering DBS surgery for Parkinson's disease, DBS surgery for essential tremor, DBS surgery for depression, DBS surgery for movement disorders or are thinking about participating in a DBS clinical trial through the NIH...please make sure you ask for an allergy test, allow them to only insert the non-dominant side of your brain at first, and have them keep you in the hospital for a minimum of 72 hours.
This is a not-for-profit website funded and written by the son-in-law of a patient who is now paralyzed and bed-ridden after having elective DBS Surgery for essential tremor.
The purpose of the web-site is to raise awareness within the community of patients considering DBS Surgery and within the community of physicians and clinical researchers who perform the surgery of the potential risks of brain damage related to allergic reactions in the brain to DBS Medtronic Activa Neurostimulator Leads. This is what appears to have happened to my father-in-law. He wants you to know about his story. (To be clear there was no evidence of stroke as the cause of his paralysis. There was, however, medical evidence of brain edema (swelling).)
His case is presented below in the hopes of prompting the NIH and US neurosurgeons into upgrading current DBS surgical protocol so that the current protocol is updated to include: 1) testing for allergies before inserting the leads into the brain, 2) keeping patients in the hospital for 72 hours or longer after insertion to monitor for patient tolerance of the leads, and 3) limiting the insertion of the leads into the brain at the time of the initial surgical procedure to only one side (the non-dominant side) of the brain.
I believe my father-in-law's situation would not be what it is today had any of those steps been taken. If you are considering this surgery, we encourage you to discuss these issues with your doctor and others outside of the medical-industrial system.
Click here to access Clarimed's data on reported adverse events resulting from Deep Brain Stimulators:
My father-in-law, Ed, was, at the time, a 77 year old otherwise healthy male with essential tremor. Due to the ongoing problems created by his tremor his doctors recommended and Ed decided to have the DBS Medtronic Activa Neurostimulator leads inserted into his brain to control the tremor.
While the surgery went as planned...and the implants appeared to be controlling the tremor...an undetected 'cloud' was apparently gathering in his brain. Oblivious to those gathering clouds, Ed was discharged to home the day after his implantation.
He never made it back home, ever.
As it turns out, he should have had a weather radio. We wish we had bought one for him. We also wished we had insisted that he not be discharged.
Sadly, those 'clouds' came in and have now left him paralyzed and bed-ridden.
We now know that, unfortunately, his brain had an 'allergic' reaction (brain edema) to the leads.
The resultant swelling caused significant brain damage.
Seven days after insertion the leads were removed...but not before the permanent brain damage had been done.
He is now in a Skilled Nursing Facility and on Medicaid...paid for by your tax dollars and mine.
Surprisingly, this is not the first time such a reaction has occurred. Even more surprisingly, current US medical 'protocol' ('the best in the world?') and current 'accepted medical practice' in the US is to 'insert the leads into the brain on an outpatient basis' and, once the patient is 'stabilized', to 'send them home'.
This is what was done to my father-in-law. He only made it about 5 miles from the hospital before the symptoms of the swelling started to show.
....by the time they figured out what had happened...the long term damage had already been done.
Quite amazingly, in other 'developed' countries it is apparently not the 'protocol' or 'accepted medical practice' to send patients home after implantation.
In other countries (such as Denmark) patients are hospitalized for up to two weeks post-implant so that their 'tolerance' (or 'intolerance') of the leads is able to be monitored.
If a reaction (or any other problem) begins to 'set up', the leads are promptly removed.
In addition, other physicians state that for patients over 70 years of age they do not place leads in 'both' sides of the brain (left and right) at the same time. Instead, they only do one side at a time...waiting (judiciously) to see how the patient tolerates the 'non dominant' side...before implanting on the 'dominant' side.
How do I know all this? I contacted 15 clinical trial directors for all the DBS implant studies being funded by NIH around the world...and a few of them told me.
I have asked the NIH (which is currently funding a dozen or so 'clinical trials' testing DBS applications for everything from MS to depression) a simple question:
Given the documented cases of allergic reaction to these leads, what is the NIH doing to protect participants in clinical trials?
In August of 2011 I was informed by the NIH that a 'letter was being prepared' to address my concerns. As of January 23, 2012 I have yet to receive that letter.
When I contacted Medtronic about the matter back in August 2011, they informed me that there was no product liability and that it was Ed's 'own body that caused his reaction'.
While this is essentially true (it was his own body that reacted)....it was certainly not the response I had been hoping for.
The response I had hoped for was something like: 'we are discussing this issue with the leading experts in the physician community and asking that they assess the our current protocol in light of your father-in-law's (and other's) cases to see how we can better protect patients from these rare 'adverse reactions'.' But, alas, I was naive.
Socrates once said that the key to wisdom is recognizing what you don't know.
In my father-in-law's case 'what we don't know' is why his brain reacted.
Yes, 'his own body...caused his reaction'....but that doesn't make it his fault.
Nor does it answer the real question...what was it between his biochemistry and the composition of the leads that caused the reaction?
Apparently, Medtronic is not interested in finding the answer to this question as they have not (as of January 23, 2012) contacted us for any information (biochemical, allergic, etc.) about my father-in-law. For Medtronic it is apparently sufficient to say, 'it was his own body that caused his reaction'. Let's move on.
Getting back to Socrates...
what we do know is that, for some unknown reason (the thing we 'don't know') my father-in-law's brain reacted to these leads. That reaction ruined his life. Since it did (and we don't know why) my concern (and Ed's) is, 'how do we protect your mother or your father...or you!..the next 'DBS implant candidate' from the same outcome?'
Keep the patient and monitor them? Do allergy tests? According to the Medtronic response the solution appears to be to 'affix the blame' to the patient ('it was his own body that caused his reaction')...and to not address the clinical protocol to protect future patients...instead, just send patients home after impantation on an 'outpatient basis' because 'outpatient surgery is safer, and more appealing, than inpatient surgery'. I underscore appears because it could well be that Medtronics is vigorously studying the issue and revising protocol. However, from where Ed sits that does not appear to be the case.
And the NIH has not (as of 1/23/12) apparently responded to my 'alert' about this issue. An alert that was raised in August, 2011? And how many patients have had leads implanted since August, 2011?
My guess is that if you have found this page you are either a family member, patient, doctor, or lawyer interested in Medtronic Deep Brain Stimulation (DBS) Activa Neurostimulators.
(Or, you could well be a Medtronic employee or investor who has set up 'Google Alerts' on this subject.)
Whoever you are, Ed and I hope to hear from you.
As Dr. Fred Alford states in 'Whistleblowers: Broken Lives and Organizational Power http://www.amazon.com/Whistleblowers-Broken-Lives-Organizational-Power/dp/0801487803/ref=sr_1_sc_2?ie=UTF8&qid=1323215314&sr=8-2-spell
"Anonymous whistleblowing happens when ethical discourse become impossible, when acting ethically is tantamount to becoming a scapegoat. It is an instrumental solution to a discursive problem, the problem of not being able to talk about what we are doing. (emphasis added) Whistleblowing without whistleblowers is not a future we should aspire to, any more than individuality without individuals or citizenship without citizens. If everyone has to hide in order to say anything of ethical consequence (as opposed to 'mere' political opinion), then we will all end our days as drivers on a vast freeway: darkened windshields, darkened license plate holders, dark glasses, speeding aggressively to God knows where. (p. 36)
1) If you are a prospective patient or family member who has had or is considering DBS surgery, please contact me at email@example.com. I would be glad to discuss my father-in-law's situation.
2) If you are a doctor interested in allergic reactions to DBS leads, please contact me at firstname.lastname@example.org. I have a Masters Degree in Public Health and, while not a clinician, I have worked at in hospitals for many years. I can put you in touch with other clinicians who are interested in this issue.
3) If you are a lawyer...my father-in-law still needs counsel. To date the lawyers whom I have approached about the case have declined due, in part, to the 'not current protocol' issue. Sad. If your firm might have an interest in his case, please contact me at email@example.com.
by Adrian Belew and The Bears
This world hangs by a slender thread,
Wrapped up in a treacherous web,
And one man pulls the string.
Bring down the whole damn thing.
Don't betray my trust.
With surgeons drawing lines on skin,
You board the plane and strap yourself in,
Its easy to understand
we hold each others lives in our hands.
Don't betray my trust.
For additional information please contact us at firstname.lastname@example.org.