Title: Adverse Events
dennis100 - October 22, 2008 07:25 PM (GMT)
As of 9/30/08 there has been a total of 8442 adverse events reported to the FDA dealing with the VNS. That sure seems like an awful lot of reports when you consider that there are approx 40,000 implants worldwide. Keep in mind that a large number of events go unreported.
I found some interesting information while searching the MAUDE reports. What stands out most is the number of unexplained deaths. Out of the 763 reported deaths 254 list the cause as "Unknown" and there are 73 listed as "SUDEP". Thats 327 deaths without a decent explanation. It doesn't take an Einstein to realize that something ain't right with that picture. How can the FDA be letting this go on ? I was nearly killed by the damn thing. I wonder if my death would have been listed as "Unknown" or "SUDEP"
Petunia - October 22, 2008 10:08 PM (GMT)
If I were to guess I would say ... it would be listed as " unknown/sudep"
Were ANY of them listed as the VNS the cause of death?
I'm sure there are a lot more then the 8442 adverse affects! I know I had some that I never reported. I'm sure their are lots of people like me!
dennis100 - October 22, 2008 10:22 PM (GMT)
The VNS was not listed as the cause of death in any of the reports.
dennis100 - October 23, 2008 01:20 PM (GMT)
Cyberonics claims that the ncp system labeling lists heart rate/rhythm changes as a potential adverse event. What they fail to mention is that the device can completely stop your heart (asystole) and possibly kill you. I should know because it happened to me. Below are 5 examples.
| QUOTE |
Model Number 101
Event Date 01/10/2006
Event Type Injury Patient Outcome Hospitalization; Life Threatening Required Intervention
Event Description
Reporter indicated that pt suddenly began to experience serious drop attacks unrelated to his epilepsy. The pt had been implanted for approx 29 months when the drop attacks began and had experienced good efficacy with the vns therapy regarding his seizure control. There had been no changes to either programmed parameters or medication regimen for approx one year. The pt was hospitalized, during which time it was discovered that he was experiencing episodes of bradycardia leading to asystole during device stimulation cycles. The pt also experienced several episodes of syncope during this time. No heart condition has been reported that the pt's device was functioning normally, although specific device diagnostic test results were not provided by physician. Stimulation has been discontinued and explant of the ncp system is planned. The episodes of syncope have reportedly resolved since the device was programmed to off; however the pt's seizures have somewhat worsened in the absence of the vns therapy (to approx 1 seizure per wk). Treating physician indicates that the reported events appear to be related to device stimulation ("vagally-induced heart block and sinus bradycardia") but does not know why the pt began to experience these events after more than two yrs of successful vns therapy.
Manufacturer Narrative
Ncp system labeling lists heart rate/rhythm changes as a potential adverse event possibly associated with surgery or stimulation. Treating physician indicates that the reported events appear to be related to device stimulation ("vagally-induced heart block and sinus bradycardia") but does not know why the pt began to experience these events after more than two years of successful vns therapy.
Manufacturer Narrative
Ncp system labeling lists heart rate/rhythm changes as a potential adverse event possibly associated with surgery or stimulation. Treating physician indicates that the reported events appear to be related to device stimulation ("vagally-induced heart block and sinus bradycardia") but does not know why the pt began to experience these events after more than two years of successful vns therapy. |
| QUOTE |
Model Number 102
Event Date 01/01/2006
Event Type Injury Patient Outcome Hospitalization; Life Threatening Required Intervention
Event Description
Vns pt was hospitalized with asystole. While hospitalized, the pt's device was programmed to off, after which his condition stabilized. While attempting to reinitiate device stimulation, the pt exhibited asystole again. Treating physician programmed the device back to off and does not plan to reinitiate stimulation. The pt had reportedly been experiencing good seizure control with the vns therapy and his device had been programmed to 3. 0ma normal mode output current "for quite a while". It was reported that since the incident, the pt is unable to tolerate even lower levels of stimulation, due to the cardiac condition. The pt is non-verbal and cannot communicate whether device stimulation feels abnormal. The pt does not have any pre-existing conditions that may have precipitated the reported event and there had been no recent changes to the pt's medication regimen. |
| QUOTE |
Model Number 101
Event Date 03/03/2008
Event Type Injury Patient Outcome Hospitalization; Required Intervention
Event Description
Initial reporter called to ask if manufacturer had any info on vns pt's experiencing asystole caused by swiping their magnet or stimulation. It was additionally reported "a pt had a seizure and the nurse swiped with a magnet. Afterwards the pt went into asystole, which lasted several seconds. The pt was in the hospital due to seizures and connected to a monitor so they were able to see it. " the pt's seizure rate was above their pre vns seizure rate and was a change for the pt. No further info has been attained from the site after good faith attempts have been made. |
| QUOTE |
Model Number 102
Event Date 09/07/2007
Event Type Malfunction Patient Outcome Hospitalization; Life Threatening Other Required Intervention
Event Description
The reporter indicated the pt was admitted to cardiac care unit for monitoring. The pt experienced an asystole and bradycardia, approx five or six mos ago. The pt was seen for video monitoring for his seizures. During the monitoring, the reporter noted that "the pt would go into "true persistent asystole with no pulse. " in addition, the pt had an asystole only during a magnet swipe which was set for 60 seconds on. The reporter stated the pt's magnet output current was set to 3. 5 ma. The reporter indicated the normal stimulation was set to 1. 5 ma. The reporter stated "the pt was having a seizure and they swiped the device initiating a magnet mode stimulation. " the reporter noted the asystole was longer, than when they swiped the pt without a seizure. The reporter stated "the asystole and bradycardia are directly related to vns stimulation. " during the pt's admission in the ccu, the reporter lowered the magnet output current to see how the pt would respond to the new settings. The reporter stated the pt was set to 2. 25ma. Thus, the pt no longer had asystole, but bradycardia. The reporter states "this setting does not help the pt's seizures to abort, but the cardiologist was fine with the bradycardia. " the reporter stated "the pt is fine now, just not getting as good of seizure control with the new setting. " good faith attempts to obtain additional info are in progress and awaiting results. |
| QUOTE |
Model Number 101
Patient Outcome Hospitalization; Life Threatening Disability
Event Description
My device was programmed to stimulate the nerve for 30 seconds every 3 minutes, when it malfunctioned it was putting me into asytole during the on cycles. My neurologist turned off the device in the er and i regained a normal heart beat. I was kept in the hospital an additional 3 days for observation. |
dennis100 - October 23, 2008 03:37 PM (GMT)
Another side effect that Cyberonics fails to mention is increased seizure activity. I guess they had their reasons for omitting that one from their literature. Who would want to buy their product if they knew it might just make matters worse. Below are some examples.
| QUOTE |
Model Number 102
Event Date 05/01/2007
Event Type Injury Patient Outcome Required Intervention;
Event Description
Reporter indicated that a vns pt experienced an increase in seizures above previous baseline. The physician also indicated the seizures were more severe. The pt's vns device was programmed off, and the seizures decreased and were less severe. Device diagnostics showed vns to be functioning properly. |
| QUOTE |
Event Type Injury Patient Outcome Life Threatening;
Event Description
Reporter indicated that patient's seizures worsened following vns implant. It was reported that the patient had daily complex partial seizures pre-vns and that after the vns implant, the patient began convulsing much worse than before. Attempts to obtain additional information has been unsuccessful to date. |
| QUOTE |
Model Number 102
Event Date 12/11/2002
Event Type Injury Patient Outcome Hospitalization; Life Threatening Required Intervention
Event Description
Vns patient's seizures are worse following vns implant. It was reported that the patient has experienced an increase in the number of seizures. The patient reportedly had a recent seizure during which they blacked-out and fell. The patient subsequently underwent ear surgery because they damaged their ear during the fall. The patient reported that they did have black-outs prior to vns implant.
Manufacturer Narrative
Report is incomplete because no response has been received to manufacturer's request for additional information from treating neurologist. |
| QUOTE |
Event Date 12/01/2001
Event Type Injury Patient Outcome Life Threatening; Required Intervention
Event Description
Reporter indicated that pt experienced an increase in seizure activity with the vns. It was reported that the pt's usual pattern was a cluster lasting 1 1/2 days every 3 weeks. Following the vns implant, the pt's clusters occurred every 8 days. When the vns was programmed to off, the pt's seizure frequency returned to every 3 weeks. When the vns was programmed back on, the pt's seizure frequency again increased to every 8 days. Attempts to obtain additional info have been unsuccessful to date.
Manufacturer Narrative
The following dates are estimated. Only the month/year is known: b. 3, date of event. D. 7, implant date. |
| QUOTE |
Model Number 102
Event Date 07/02/2003
Event Type Injury Patient Outcome Life Threatening; Required Intervention
Event Description
Reporter indicated that vns patient has experienced an increase in seizures since stimulation was initiated. It was reported that before vns therapy, the patient had 7 - 8 petit mal seizures per month and that post therapy, patient has 3 - 4 petit mal seizures per day. Treating neurologist indicated that the patient had requested a reduction in programmed parameters due to the increase in seizures. Neurologist indicated that the increase was possibly related to the vns therapy. |
Birdbomb - October 23, 2008 04:24 PM (GMT)
The ratio of reduced seizure activity to increased activity from, my understanding, is about equal. The 1/3 ratio still stands* even though the NEW marking ploy attemps to make the results sound more promising. They fail to include ALL implanted VNS in their results, they market it as the ACITVATED VNS. Keep in mind that HALF of all implanted VNS have been de-activated. Depression has even less success.
Dennis you have done a fantastic job of hunting these down. Even though they never state VNS as a cause of death, it cannot be ruled out as a possibility. If the VNS stops the heart then yes, it IS the cause of death. Very cleverly written statements there.
OH and one other thing....these numbers and reports are ONLY from the United States!
*1/3 recieve some benifit, 1/3 no change, 1/3 worse off than before
dennis100 - October 24, 2008 03:01 PM (GMT)
Well we have established that the VNS can stop your heart. Now the next logical question is - Can it kill you ? Below are 5 maude reports submitted by Cyberonics. As you will see when you read the reports Cyberonics does not think that their little device caused the deaths but they admit that it could have.
| QUOTE |
Model Number 101
Event Date 05/08/2002
Event Type Death Patient Outcome Death;
Event Description
Mfr periodically compares device tracking info to the social security death index for the purpose of updating device tracking data. Mfr became aware of pt death during this process and evaluated available info against current procedures. The event did not meet mdr reporting criteria per mfr's current procedures. In an effort to obtain additional info regarding pt deaths for summary reporting request, certificate of death was requested, received and reviewed by mfr. Death cetificate indicates that pt died while hospitalized. Immediate cause of death is listed as sudden cardiac death, due to or as a consequence of myocardial infarction. There is no evidence that the ncp system caused or contributed to the reported event; however, based on the reported cause of death, although it is not believed that it is likely that the vns therapy caused or contributed to the pt's death, it cannot be definitively ruled out as a factor.
Manufacturer Narrative
H. 6. Review of manufacturing records for both the pulse generator and the bipolar lead revealed no anomalies that would adversely effect device performance. |
| QUOTE |
Model Number 102
Event Date 04/01/2005
Event Type Death Patient Outcome Death;
Manufacturer Narrative
Approx 21 months prior to death, the pt experiened shortness of breath, constant chest pain, and palpitations following an increase in programmed parameters. The symptoms reportedly subsided when device parameters were reduced to pre-symptomatic levels. Reference medwatch report 1644487-2003-00482.
Event Description
Mfr periodically compares device-tracking info to the social security death index for the purpose of updating device-tracking data. During this process, mfr became aware of a pt death. Certifcate of death was requested, received and reviewed by mfr. Death certificate indicates that the pt died at his residence. Immediate cause of death is listed as sudden cardiopulmonary failure. Autopsy was not performed. Investigation to date has been unable to determine whether the reported event was related to the vns therapy system as the identity of the pt's last known treating physician is unk. There is no evidence that the vns therapy system caused or contributed to the reported event; however, based on the reported cause of death, although it is not believed that it is likely that the vns therapy caused or contributed to the pt's death, it cannot be definitively ruled out as a factor. |
| QUOTE |
Model Number 101
Event Date 12/12/2002
Event Type Death Patient Outcome Death;
Event Description
Mfr periodically compares device tracking info to the social security death index for the purpose of updating device tracking data. Mfr became aware of pt death during this process and evaluated available info against current procedures. The event did not meet mdr reporting criteria per manufacturer's current procedures. In an effort to obtain additional info regarding patient deaths for summary reporting request, certificate of death was requested, received and reviewed by the mfr. Death certificate indicates that pt died while hosptialized. Immediate cause of death is listed as cardiopulmonary arrest. No autopsy was performed. There is no evidence that the ncp system caused or contributed to the reported event; however, based on the reported cause of death, although it is not believed that it is likely that the vns therapy cause or contributed to the patient's death, it cannot be definitively ruled out as a factor.
Manufacturer Narrative
Report is incomplete because no response has been received to manufacturer's request for additional info from treating neurologist. H. 6. Review of manufacturing records for both the pulse generator and the bipolar lead revealed no anomalies that would adversely effect device performance. |
| QUOTE |
Model Number 101
Event Date 11/09/2002
Event Type Death Patient Outcome Death;
Event Description
Mfr periodically compares device tracking info to the social security death index for the purpose of updating device tracking data. Mfr became aware of pt death during this process and evaluated available info against current procedures. The event did not meet mdr reporting criteria per manufacturer's current procedures. In an effort to obtain additional info regarding pt deaths for summary reporting request, certificate of death was requested, received and reviewed by mfr. Death certificate indicates that pt died at home of cardiac arrest. No autopsy was performed. It was reported that the pt experienced a >25% reduction in seizures with the vns therapy and that the pt was receiving therapy at the time of death. Treating neurologist indicated that the death was not related to the ncp system. There is no evidence that the ncp system caused or contributed to the reported event; however, based on the reported cause of death, although it is not believed that it is likely that the vns therapy caused or contributed to the patient's death, it cannot be definitively ruled out as a factor.
Manufacturer Narrative
H. 6. Review of manufacturing records for both the pulse generator and the bipolar lead revealed no anomalies that would adversely effect device performance. |
| QUOTE |
Model Number 100
Event Date 05/24/2000
Event Type Death Patient Outcome Death;
Event Description
Mfr periodically compares device tracking info to the social security death index for the purpose of updating device tracking data. Mfr became aware of pt death during this process and evaluated available info against current procedures. The event did not meet mdr reporting criteria per mfr's current procedures. In an effort to obtain add'l info regarding pt deaths for summary reporting request, certificate of death was requested, received and reviewed by mfr. Death certificate indicates that pt died in hosp e. R. Immediate cause of death is listed as pulseless electrical activity (for minutes duration), due to or as a consequence of severe seizure disorder (for years duration). No autopsy was performed. There is no evidence that the ncp system caused or contributed to the reported event; however, based on the reported cause of death, although it is not believed that it is likely that the vns therapy caused or contributed to the pt's death, it cannot be definitively ruled out as a factor.
Manufacturer Narrative
Report is incomplete because no response has been rec'd to mfr's request for add'l info from treating neurologist. H. 6. Review of mfg records for both the pulse generator and the bipolar lead revealed no anomalies that would adversely effect device performance. Review of device programming history revealed that device diagnostic testing on day of implant was within normal limits, indicating proper device function at that time. |
Birdbomb - October 24, 2008 04:56 PM (GMT)
| QUOTE |
| although it is not believed that it is likely that the vns therapy caused or contributed to the pt's death, it cannot be definitively ruled out as a factor. |
I believe that particular disclaimer is placed on most of the reported deaths. Oh Dennis, you should have been on their own messageboard. They posted one disclaimer after another, it would have been almost funny but it was really very sad. So many people hurt and asking questions, NOT to Cyberonic$ but to other members and their dufus spokesmen Donney Wesley would chime in with the disclaimer. It got to the point where people would post for Cyberionic$ to shut the hell up so they could compare side effects with others. Shortly after that they closed their boards.
The boards were closed because people were telling the of their experiances. Not the lie of day treaders taking over the boards like they want people to believe. I was on that site every day, and for the last month, I took screen shots. NOT ONE DAY TRADER ever posted.
A company can post disclaimers, but that does not release them from liability or responsibility. Watch....things will happen...they have made their bed.
Thank you again Dennis. I know how hard it is to read these reports. You have to be in a certain mindset or else you just rage thinking "How can this happen?" You are a very special person to do this for everyone. I hope they can appreciate all you efforts.
dennis100 - October 24, 2008 10:33 PM (GMT)
A couple of more interesting reports.
| QUOTE |
Model Number 100
Patient Outcome Hospitalization; Life Threatening
Event Description
Pt had a cyberonics vagal nerve stimulator implanted 2 wks ago. Stimulator turned on 10/18/1999. Pt had an acute mi 3-4 hrs later. |
| QUOTE |
Model Number 102
Event Date 03/28/2007
Event Type Death Patient Outcome Other;
Event Description
Reporter indicated that a vns pt expired. The pt had been seen by her treating physician for initial vns therapy system dosing the day prior to having expired. There was probable cause to believe it was due to sudep (sudden unexplained death in epilepsy). |
Bernard - October 25, 2008 04:02 PM (GMT)
The FDA does not claim copyrights over their material, so it is OK to quote the reports.
dennis100 - October 29, 2008 11:11 PM (GMT)
Another VNS patient dies within 24 hours of activation.
Model Number 102
Event Date 06/27/2008
Event Type Death Patient Outcome Death;
Event Description
It was reported that the vns epilepsy pt passed away. The physician informed the mfr that the cause of death was sudep. Treating physician reported that the pt's generator was inadvertently programmed off and determined that the pt was without vns therapy for approx 5 months (refer to mfg report # 1644487-2008-01741). Pt's device was then programmed back on to 0. 5ma. The pt passed away the following day. An autopsy was performed. The treating physician reported that death was not related to vns therapy. Pt's generator and lead were explanted after death and returned to the mfr. Analysis on the returned generator has been completed. There were no performance or any adverse conditions found with the pulse generator during lab analysis. Prod analysis on the explanted lead is pending. Good faith attempts to obtain autopsy results and programming history have been unsuccessful to date.
http://www.accessdata.fda.gov/scripts/cdrh...FOI__ID=1091663 Dispatch - October 30, 2008 11:37 AM (GMT)
<_< What gets to me is the above report doesn't say if the patient had a seizure immediately prior to death, so how can the doc claim SudEP? The autopsy should show if there was a cardiac issue.
Gosh Dennis, you are one strong person to be able to research & read about all these deaths. It has got to be impacting you. How are you doing? I am so grateful you made it thru your near death experience, and I applaud and admire you for all you've done. You are ACE in my book.
Dispatch B)
dennis100 - October 30, 2008 01:39 PM (GMT)
Well Dispatch, If some punk shot me a few times and I managed to survive, the law would see to it that the perpetrator was sent to jail for a very long time. We have remedies for that kind of situation. Now when a medical device endangers your life or kills you the manufacturer can not be held responsible (thanks to the Supreme Court). Where is the justice ?
Cyberonics has a pretty good thing going for them. No red flags are going to be thrown up when a person with epilepsy dies. It will normally just be written off as a natural death. No need to investigate further.
I do not take kindly to having my life threatened. My parents have already buried two of their sons and thanks to Cyberonics they came awful close to burying a third. Obviously the FDA pays little or no attention to the maude reports, if they did this device would have been taken off the market years ago.
Birdbomb - October 30, 2008 04:43 PM (GMT)
If it were a malfunction, it would be pulled off the market, but this is death under normal operations. It's the body's reaction to the stimulation of the vagus nerve. However the smoking gun is STILL the VNS. The question is, "Would all these people be still alive if there were NO VNS in the picture?" IMHO, I think a good many of them would be. Especially this above posting. Dead in 24 hours.
How terribly tragic for these families. :So Sad:
dennis100 - November 9, 2008 01:24 AM (GMT)
Another interesting MAUDE report.
Adverse Event Report
CYBERONICS, INC. NI PULSE GENERATOR
Event Type Injury Patient Outcome Life Threatening;
Event Description
Manufacturer became aware of a published clinical article summarizing the author's experience with vagus nerve stimulation as a neurophysiologic treatment for patients with refractory epilepsy. The article discusses a study on 15 epilepsy patients and indicates that 2 of 15 patients experienced an increase in seizure frequency with the vns therapy.
http://www.accessdata.fda.gov/scripts/cdrh...RFOI__ID=643726 kathie - November 9, 2008 05:01 AM (GMT)
Dennis, I like you, you are straight to the point with no bullshit. My 20 yr old daughter Lauren was zapped one day, rushed to CCU and when Cyberonics came to turn the unit off she was fine. This happened in May and I will die before I give up trying to get this company to pay for what happened to my daughter. We thought she was going to die and by the grace of God she didn't. She is being explanted 11/24/08 and she can't wait. She has recently told me since the moment that thing was turned on she hasn't felt like the same person. She had it implanted for seizures. Her whole personality has changed, lots of depression and impulsive behavior. She doesn't care what she does or how she looks. We as a family have been going through some really tough times. She can't wait to have it out. I swear to you one way or another they will pay!!!! They put my child's life in danger and didn't tell me all the bad things that could happen to her. When she was zapped they said we never heard anything like that happening before, well that's total bullshit. Somebody told me Cyberonics is going under, I wish! i could go on all night but what comes around goes around and i can't wait. Kathie MOL (mom of Lauren) :Yeah That: :Yeah That:
dennis100 - November 10, 2008 01:38 AM (GMT)
In the most recent study, most patients showed at least some
improvement with the vagus nerve stimulator. Half the patients
treated had at least a 20 percent reduction in the number of
seizures per day. In about 1 in 4, the frequency of seizures
decreased by more than 50 percent. In about 1 in 5, however, the
number of seizures actually increased.
The above quote was taken from a 1997 FDA press release. This shows that the FDA is well aware that the VNS will worsen the condition of 20% of patients who are desperate enough to try it yet they allow Cyberonics to conveniently omit that important little detail as a potential adverse event. WHAT IS GOING ON HERE ?
http://www.fda.gov/bbs/topics/NEWS/NEW00576.html gel61820 - November 10, 2008 01:49 AM (GMT)
:Yeah That: Just shaking my head here, wondering what has to happen to make the FDA recognize the need for further research!!!
Thanks for finding all these events and passing along the information, Dennis.
Hugs,
Cindy
dennis100 - November 10, 2008 02:34 PM (GMT)
Adverse Event Report
CYBERONICS, INC. VNS THERAPY PULSE PULSE GENERATOR
Model Number 102
Event Date 03/01/2004
Event Type Injury Patient Outcome Life Threatening;
Event Description
Reporter indicated that pt has recently experienced an increase in seizures. It was reported that the pt experienced 1-2 seizures per year prior to vns implant and that pt recently experienced 3 seizures within one month. Treating neurologist indicated that the pt was doing fine and that the reported event was not related to the vns. The pt's seizures types had not changed. The pt's health condition is reportedly not worsening and there were no environmetal stimuli that may have contributed to the increase in seizure activity. Neurologist indicated that programming the pt's device to off resulted in no change to the pt's condition or symptoms.
This patient should have never been a candidate for VNS surgery to begin with.
What was his doctor thinking ?
Was he trying to reduce the 2 yearly seizures down to 1 ?
http://www.accessdata.fda.gov/scripts/cdrh...RFOI__ID=522645 Dispatch - November 10, 2008 09:03 PM (GMT)
Darn sad to say but the truth, being a proper candidate is not ever a priority with Cyberonics. <_< It doesn't matter to them and some doctors. Dennis, this person's doctor was thinking $$$, the same as Cyberonics who also knew this patient was not a candidate.
I am shaking my head right along with anyone else reading this. The proof is right here. I can't say enough this company needs Dept. of Justice regulation. The FDA is not doing their jobs. They were in the beginning when many employees did not agree there was not substantial evidence thru the studies this was safe & effective. They were dismissed by 1 person, this went on the market, and now those employees are silent. If the FDA steps up now, they would be admitting fault and we all know that's not going to happen anytime soon. I wonder if President Elect Obama is going to do what Bush did and listen to the Senate Finance Committee about Cyberonics-this is why there has been an ongoing investigation. It is not just about securities fraud. I wonder how Senator Grassley (Chair of the Senate Finance Committee) would take getting flooded with letters from patients. :huh:
VNS needs to be researched further for safety and everything about the device disclosed. Cyberonics needs to be held to the standards pharma is. I know there are studies going on now, but those are for parameter settings. I haven't read where there are studies being done to further establish safety. OK, OK, we all know meds can hurt a person too, but why is it Pharma has to diclose and Cyberonics doesn't? Why do I see ads on TV for Chantix (the stop smoking aid) that makes it clear if you have problems with depression you should re-evaluate with your physician taking that med, but yet Cyberonics places ads that still does not disclose everything about VNS. I read one recently thatI got in the mail (yeah, I got it in the mail) which said basically the only side effect was horseness. Geez, I wish that had been the only side effect for me....3 surgeries later because of VNS and I may not be done yet.
I saw on the TV the other day a commercial for an attorney's office saying if you had a loved one who committed suicide from taking a seizure med call the number. One day there will be a commercial about VNS whether it be for suicide or deaths or serious injury, etc. Some food for thought...the way I understand it, the Supreme Court only ruled on malfunctioning devices.
Dispatch B)
dennis100 - November 10, 2008 09:32 PM (GMT)
Here is another simular report.
Adverse Event Report
CYBERONICS, INC. NI PULSE GENERATOR
Event Date 01/01/2003
Event Type Injury Patient Outcome Life Threatening;
Event Description
Reporter indicated that the pt had experienced a total of 13 seizures the year prior and that pt had only experienced a total of 5 seizures 3 years before, prior to being implanted with vns therapy system.
http://www.accessdata.fda.gov/scripts/cdrh...RFOI__ID=550791 dennis100 - November 11, 2008 02:31 PM (GMT)
[QUOTE] In about 1 in 5, however, the number of seizures actually increased.
I just can't get this off of my mind. If my doctor was up front with me about this common side effect there is no way in hell that I would have ever consented to the surgery. I was desperate at the time and he sugar coated some possible side effects (sore throat, hoarseness, cough, etc) and added that if they become bothersome I could just simply have the device removed. Sounded great to me.
Surely my doctor had to know that increased seizure activity was a very common side effect. Cyberonics studies show that it occurs in 20% of VNS patients, at least that is what they told the FDA. My guess is that it they fudged their figures to get approval of their little device and that 20% figure is probably closer to 40%.
Birdbomb - November 11, 2008 05:34 PM (GMT)
Keep in mind, Dennis, the current stats that Cyberonic$ is using, ONLY accounts for only the number of ACTIVE VNS, not the total implanted. This is a marketing ploy to make it sound more successful than it really is. They started this misleading practice right after CMS refused to pay.
| QUOTE |
If my doctor was up front with me about this common side effect there is no way in hell that I would have ever consented to the surgery. I was desperate at the time and he sugar coated some possible side effects (sore throat, hoarseness, cough, etc) and added that if they become bothersome I could just simply have the device removed. Sounded great to me.
|
You are not alone in this. Many have expressed the same distress. It just goes to show you how the doctors we trust, can be either duped into believing the same hype or do it for the $$$$
dennis100 - November 11, 2008 09:59 PM (GMT)
You were right Dispatch, Cyberonics along with some doctors and surgeons couldn't care less if you are a proper candidate for surgury or not.
Below is another example.
Adverse Event Report
CYBERONICS, INC. VNS THERAPY PULSE PULSE GENERATOR back to search results
Model Number 102
Event Date 11/01/2002
Event Type Injury Patient Outcome Life Threatening;
Event Description
Patient has had an increase in seizures since their implant. The patient had been having 1 seizure every month or every other month and is now having 2-3 seizures a month.
http://www.accessdata.fda.gov/scripts/cdrh...RFOI__ID=448108 dennis100 - November 12, 2008 12:57 AM (GMT)
This poor guy really had a tough time with Cyberonics little device.
Adverse Event Report
CYBERONICS, INC. PULSE GEN MODEL 102 LYJ
Model Number 102
Event Date 08/24/2005
Event Type Injury Patient Outcome Hospitalization; Life Threatening Required Intervention
Event Description
Upon inititation of stimulation, the pt experienced more seizures than usual, requiring several emergency room visits for treatment of breakthrough seizures. Stimulation was initiated three weeks post implant and was discontinued approximately 5 months later due to the increase in seizure activity. It was reported that when stimulation was discontinued, the pt progressively returned to his previous neurological status (previous number of seizures per day). Two months after discontinuing stimulation, the device was programmed back to on, after which the pt developed several complex, partial, atonic, and generalized tonic-clonic seizures within 30 to 60 minutes. An eeg performed on that same day showed almost continuous bilateral epileptiform activity. The pt was subsequently admitted to the intensive care unit for treatment of nonconvulsive status epilepticus. The pt has no previous history of nonconvulsive status epilepticus. Changes to device settings were not attempted prior to discontinuation of stimulation because the treating physician believed that it was risky to keep the device prpgrammed to on. There were no medication changes at the time of the event and the pt is reportedly compliant with his antiepileptic medication regimen.
http://www.accessdata.fda.gov/scripts/cdrh...RFOI__ID=723939 Dispatch - November 12, 2008 04:16 AM (GMT)
Oh my goodness, another report of an extremely rough road to go down. It seems to be never ending.
I re-read some of the above posts and some state the Mfr. looks at the Social Security Death Index (SSDI). Well, my Mom died in 1991 and until recently, she was not listed in the SSDI even though her death was reported to Social Security. It also appears as of todays date that my Mother-in-Law is still alive but she has been gone since 1983-she is not in the SSDI. That tells me the SSDI is not accurate.
What I don't understand is in all these reports there's the catch all answer from Cyberonics which is not accurate. Why is this allowed, and why has there been no consequences? The FDA has all this information from the reporters, so why aren't any of these being looked into by the FDA?
Dispatch B)
dennis100 - November 12, 2008 08:56 PM (GMT)
I truly believe that the FDA pays no attention to the maude reports. I filed a report back in Sept of 06. Three months ago I contacted the FDA to find out the results of any investigation into the matter.
I was informed that my report would be forwarded to the device analyst for the neurological panel and was told that they have the authority to write to Cyberonics and request that they conduct an investigation.
Boy does that ease my mind. Cyberonics gets to investigate themself. But that will only happen if the neurological panel asks them to do so.
I filed a report of my near death experience over two years ago and the FDA does nothing with it until I inquire about it. And now instead of a FDA investigation I (might) get a Cyberonics investigation.
This is how the FDA protects the public. UNBELIEVABLE
dennis100 - November 12, 2008 11:46 PM (GMT)
Adverse Event Report
CYBERONICS, INC. NCP PULSE GENERATOR PULSE GENERTOR
Model Number 101
Event Date 03/25/2004
Event Type Death Patient Outcome Death;
Event Description
Reporter indicated that vns patient had passed away. It was reported that the patient was walking into a room and simply dropped dead. Treating neurologist indicted that the death may be cardiac-related, but is not sure as autopsy results are pending. Cause of death is not known at this time. There is no evidence at this time that the ncp system caused or contributed to the reported event.
http://www.accessdata.fda.gov/scripts/cdrh...RFOI__ID=522043 Dispatch - November 13, 2008 04:17 AM (GMT)
And what is a common answer when Cyberonics investigates themselves is "User Error".
Dispatch B)
dennis100 - November 13, 2008 10:52 AM (GMT)
I would expect something like this.
Manufacturer Narrative
Asystole occurred, but is not suspected to be related to vns therapy. Device failure is not suspected.
Dispatch - November 13, 2008 11:48 AM (GMT)
| QUOTE (dennis100 @ Nov 13 2008, 05:52 AM) |
I would expect something like this.
Manufacturer Narrative
Asystole occurred, but is not suspected to be related to vns therapy. Device failure is not suspected. |
The usual "device failure is not suspected" is also misleading-another catch all answer. What people may think is the device will only cause asystole if it malfunctions and that is not the whole truth. It can cause asystole if it is functioning properly. What people need to understand is the device can be functioning properly (mechanically speaking), yet not be working for treament.
Dispatch B)
dennis100 - November 13, 2008 01:09 PM (GMT)
Under the precaution section of the VNS manual Cyberonics warns:
"The safety of this therapy has not been systematically established for patients
experiencing bradycardia or asystole during VNS Therapy System
implantation."
As of 9/30/08 there have been 60 reported incidents of bradycardia and asystole during intraopertive lead tests.
Out of those 60 only 18 surgeries were aborted.
dennis100 - November 13, 2008 01:52 PM (GMT)
A very interesting MAUDE report.
Adverse Event Report
CYBERONICS, INC. NCP SYSTEM NERVE STIMULATOR GENERATOR
Model Number 100 NCP GENERATOR
Patient Outcome Life Threatening;
Event Description
On sept 18, 1998 an incident occurred in the operating room, which rptr feels should be brought to fda's attention. Pt is a 38-year-old male with a long-standing history of medically intractable seizures. Based on previous investigations and consensus agreement at a conference, the pt was deemed be a good candidate for implantation of vagal nerve stimulator. This is an fda approved device mfg by cyberonics, which has been demonstrated effective in the treatment of medically intractable partial seizures. The pt had been explained the risks and benefits of the procedure and had consented to surgery. The procedure was performed on friday, september 18, 1998 in the afternoon under general anesthetic. A left vagal nerve lead was placed over the vagus nerve, which had been clearly identified. Before connecting the generator to the lead, the vagal nerve generator had passed a routine diagnostic test. It was then attached to the vagal nerve lead, which was wrapped around the left vagus nerve. The lead test was then performed. This involves the generator stimulation of the vagus nerve. As soon as the lead test was commenced, the pt became asystolic. This test was aborted and the pt reverted to sinus rhythm. The duration of asystole was approximately 10 seconds. This was recorded by the anesthetist. Interrogation of the device was performed by the neurophysiologist of the dept of neurology. A nurse who was a rep of cyberonics was present at the time of the procedure. A backup generator was then connected to the vagal nerve lead. It's diagnostics as well were normal and when the lead test was performed, the pt's pulse did not change. The initial generator then underwent a repeat diagnostic test, which again revealed the generator to be normal. A lead test with the original generator was then repeated. The pt again became briefly asystolic. This test was immediately aborted. At this point, a decision was made not to implant a stimulator in this pt given the unk etiology of this arrhythmia. The vagal nerve lead was then removed from the vagus nerve. The device was then put under the care of a dr, the dept of neurology and the nurse rep from the cyberonic's co. The operative field was irrigated and closed. General endotracheal anesthesia was reversed and the pt was examined and found to be neurologically normal. His vital signs were stable. He was maintained in a monitored setting overnight and was seen in consultation by an attending cardiologist, who concluded that his heart was normal. A full or incident report was filed and submitted to the operating room. Rptr has filed an oral report with the food and drug administration. As well, rptr has contacted cyberonics concerning this incident and questioning implantation of the vagal nerve stimulator device.
http://www.accessdata.fda.gov/scripts/cdrh...RFOI__ID=188325 dennis100 - November 13, 2008 03:22 PM (GMT)
| QUOTE (dennis100 @ Nov 13 2008, 05:09 AM) |
Under the precaution section of the VNS manual Cyberonics warns:
"The safety of this therapy has not been systematically established for patients
experiencing bradycardia or asystole during VNS Therapy System
implantation."
|
Also under the precaution section Cyberonics advises "If a patient has experienced asystole, severe bradycardia (heart rate < 40 bpm) or a clinically significant change in heart rate during a Lead Test at the time of initial device implantation, the patient should be placed on a cardiac monitor during initiation of stimulation.
That seems to indicate that Cyberonics couldn't care less about the health of the patient. On one hand they suggest it could be dangerous for the patient if you proceed with the surgery and on the other hand they say its OK but be careful when you start stimulation.
Birdbomb - November 13, 2008 05:15 PM (GMT)
| QUOTE (dennis100 @ Nov 13 2008, 03:52 AM) |
I would expect something like this.
Manufacturer Narrative
Asystole occurred, but is not suspected to be related to vns therapy. Device failure is not suspected. |
Yet it never happened AGAIN after the VNS was turned off.
*shakes head in disgust and unbelief*
So the patient has NO history of heart problems, the VNS did NOT mafunction, but is not suspected to be related to vns therapy because it's KNOWN heart rate to change as direct cause from having the vagus nerve stimulated.
~Every dog has it's day~
dennis100 - November 13, 2008 07:55 PM (GMT)
Adverse Event Report
CYBERONICS, INC. NCP PULSE GENERATRO PULSE GENERATOR
Model Number 101
Event Date 05/02/2005
Event Type Injury Patient Outcome Life Threatening;
Event Description
Reporter indicated that after increasing programmed parameters, the pt experienced a choking sensation. During the episode, the pt's eyes became dilated and pt passed out. Treating neurologist was unable to get a pulse for a short period of time, but reported that the pt regained consciousness after prgrammed settings were reduced to original parameters. The pt was sent home in good condition after resting in the doctor's office. It was reported that programmed parameters were increased due to an increase in seizures activity; however, investigation to date has been unable to determine whether the increase was above pre-vns baseline frequency. At follow-up office visit two days later, device diagnostic testing with within normal limits, indicating proper device function. Normal mode output current was reduced from 1. 25ma to 1. 0ma.
http://www.accessdata.fda.gov/scripts/cdrh...RFOI__ID=613869 dennis100 - November 13, 2008 10:58 PM (GMT)
Adverse Event Report
CYBERONICS, INC. PULSE GEN MODEL 102 back to search results
Model Number 102
Event Date 01/08/2007
Event Type Death Patient Outcome Other;
Event Description
Initial reporter indicated that a vns pt had died due to a "seizure disorder ". He indicated that the death was related to sudep, "because everything else has been ruled out. " he did not believe that the vns caused or contributed to the pt's death.
I wonder how they were able to rule out the VNS as the cause of death.
http://www.accessdata.fda.gov/scripts/cdrh...RFOI__ID=861006 dennis100 - November 13, 2008 11:24 PM (GMT)
Adverse Event Report
CYBERONICS, INC. NCP PULSE GENERATOR
Model Number 101
Event Date 04/24/2003
Event Type Death Patient Outcome Death;
Event Description
Reporter indicated that vns pt had passed away. Exact cause of death is unknown at this time. There is no evidence at this time that the ncp system caused or contributed to the reported event.
Manufacturer Narrative
Report is incomplete because attempts to obtain add'l info have been unsuccessful to date. No response has been received to mfr's requests for add'l info from treating neurologist. H. 6. Device mfg records were reviewed. Review of mfg records for both the pulse generator and the bipolar lead revealed no anomalies that would adversely effect device performance.
Manufacturer Narrative
Further follow-up revealed that an autopsy was not performed. Physician indicated that the patient's death was "probably" sudep. The patient was found dead in the morning. Physician indicated that the ncp system was not related to the cause of death.
I don't get this one. How can the doctor say the VNS was not related to the cause of death when he is only guessing that the patient died of sudep ?
http://www.accessdata.fda.gov/scripts/cdrh...RFOI__ID=464220 gel61820 - November 14, 2008 03:39 AM (GMT)
Seems to me that SUDEP is being used too easily! I do not see why these deaths are not being investigated instead of just casting it off as SUDEP. I guess for some families they don't want to go through autopsies however if something happened to me, I can guarantee you that my family would have the VNS explored!
As for the one about choking - yep, that happened to me when I went from .75 to 1.00 - could not breath and it had to be turned off immediately! They lowered the pulse width to 130 when I went back a few days later (it shook my neuro up so much when I was choking that he didn't turn it back on for a few days!) and then I was able to handle the 1.00. I never was able to go any higher than 1.0 and pulse width of 130 because I would always start coughing/choking and could not catch a breath.
I am so very thankful that in less than 2 weeks this dern thing will be out of me!!!!!!!
Thanks for all your research, Dennis. I just shake my head too, like BB, it just boggles my mind when I read these reports you have found. So easy to see the similarities by the lay person but the professionals just turn a blind eye to it. Wonder who paying whom?????!!!!!!!!!
Hugs,
Cindy
dennis100 - November 14, 2008 11:27 AM (GMT)
Adverse Event Report
CYBERONICS, INC. CYBERONICS NEUROCYBERNETIC PROSTHESIS NEUROSTIMULATOR back to search results
Model Number 100
Event Date 06/05/1998
Event Type Death Patient Outcome Death;
Event Description
Describe event or problem: pt death.
Manufacturer Narrative
Field report: pt death reported. Stated not related to device. Pt death follow-up form: physician reports believed relationship between the ncp system and cause to be unk, but "likely sudep".
http://www.accessdata.fda.gov/scripts/cdrh...RFOI__ID=318091