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VNS Horror Story
Tue, 01/08/2008 - 16:44I was diagnosed with epilepsy 16 years ago at the age of 34. My seizures have never been controlled with medications. Due to multiple focal points I didn't qualify for brain surgery. My neurologist suggested the VNS and I decided to give it a shot. I had the surgery on 7/21/00. The device never helped my condition but I didn't regret my decision to try it, that is until 7/02/06 when the device nearly killed me. On that date I started having what I thought were atonic seizures (I know better now). The episodes began with a sudden sharp pain to the throat followed by a split second of choking and then 30 seconds of unconsciousness. I never had atonics before and thought the throat pain/choking were just a strange kind of aura. My parents happened to stop by that sunday morning for a visit. They realized something was terribly wrong and called my neuro and EMS. My last memory of that morning was being inside of an ambulance. The next thing I remember was waking up in the ICU. What was actually happening is the device was stopping my heart (asystole) during the 30 second on cycles. Once my neuro realized that the problem was cardiac and not seizure activity he had to rush to his office to retrieve the equipment to deactivate the VNS. Once the device was turned off I regained a normal heart beat and have never had another "atonic" since. My VNS was programmed at 30 sec/3 min and I experienced approx 40 episodes of asystole. It's a miracle that I survived that ordeal.
Comments
Re: Wht happened then where they
Submitted by laracroftisme on Wed, 2009-05-06 - 21:52
Re: Wht happened then where they
Submitted by tcameron on Sun, 2010-10-03 - 23:01
Thank you for this information. My neurologist keeps asking me to consider this surgery. He's never told me anything like this. I just saw him 3 days ago, and he told me that "the VNS surgery is safe. If it prevents one seizure injury, it's worth it."
I'm not surprised that Cyberonics lied. I'll do more research on this topic. I'm sorry you had to go through such horrible cardiac side effects.
- tlc
Thank you for this information. My neurologist keeps asking me to consider this surgery. He's never told me anything like this. I just saw him 3 days ago, and he told me that "the VNS surgery is safe. If it prevents one seizure injury, it's worth it."
I'm not surprised that Cyberonics lied. I'll do more research on this topic. I'm sorry you had to go through such horrible cardiac side effects.
- tlc
Re: Wht happened then where they
Submitted by dennis100 on Fri, 2009-04-24 - 09:40
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=758211
Cyberonics has a history of failing to report adverse events to the FDA. Below is one of the two warning letters they received from the FDA.
http://www.fda.gov/foi/warning_letters/archive/g1054d.pdf
I contacted the FDA to find out if Cyberonics ever reported the incident. This is a quote from the email i received.
" I did not find any information among the events reported by the firm that I would link to your event. "
I have a suggestion for anyone considering the VNS. Look through the FDA MAUDE reports before you decide on surgery. The sheer number of reports will amaze you. Keep in mind that those are only the ones that were REPORTED. Also check out the REPORTED deaths. A large number of those list the cause as either "Unknown" or "SUDEP." If my parents hadn't shown up that morning i'm sure that my death would have fallen into one of those two categories.
One month after the incident i had a meeting with my Neurologist and a Cyberonics rep. After the rep reviewed the hospital reports, EKG strips, x-rays, etc. he asked my doctor to perform a lead test (turn on device). My doctor got angry with that fool and told him that he would never think of doing such a thing. I guess that the rep just wanted to see if my heart actually does stop beating during the stimulation cycles. WHAT AN IDIOT !!!!!!!. After things calmed down a bit the rep told me that out of all the VNSs worldwide an incident like mine had only occurred one time before. Well all it took was a little searching of the FDA MAUDE reports to realize that the rep was lying to me. My doctor asked the rep if his company planned on reporting the event to the FDA. The rep danced all around the question and never gave an answer. I filed a report after I realized that Cyberonics had no intention on doing so.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=758211
Cyberonics has a history of failing to report adverse events to the FDA. Below is one of the two warning letters they received from the FDA.
http://www.fda.gov/foi/warning_letters/archive/g1054d.pdf
I contacted the FDA to find out if Cyberonics ever reported the incident. This is a quote from the email i received.
" I did not find any information among the events reported by the firm that I would link to your event. "
I have a suggestion for anyone considering the VNS. Look through the FDA MAUDE reports before you decide on surgery. The sheer number of reports will amaze you. Keep in mind that those are only the ones that were REPORTED. Also check out the REPORTED deaths. A large number of those list the cause as either "Unknown" or "SUDEP." If my parents hadn't shown up that morning i'm sure that my death would have fallen into one of those two categories.