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Author Topic: Misc. Adverse Events  (Read 124706 times)
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dennis100
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« on: October 22, 2008, 07:25:54 AM »

Model Number 102
Event Date 12/01/2014
Event Type Injury
Event Description
It was reported that the patient is looking to explant the vns device. The patient states that she needs the device removed because for the last several years she has complained of fatigue, diarrhea, decreased libido, headaches, blood pressure fluctuations and slurred speech. Follow-up with the physician showed that these issues are thought to be related to vns therapy, resulting in vagus nerve dysfunction.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4634916
« Last Edit: April 17, 2015, 11:07:07 PM by dennis100 » Logged
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« Reply #1 on: October 22, 2008, 10:08:29 AM »

Model Number 102
Event Date 02/02/2015
Event Type Death
Manufacturer Narrative

Event Description
It was reported that the patient was declared brain dead with herniation syndrome of undetermined cause two days following generator replacement. It was noted that the physician had no concern for vns dysfunction leading to the patient's immediate demise; however, the relationship of the vns surgery was not identified. No additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4632083
« Last Edit: April 17, 2015, 11:08:03 PM by dennis100 » Logged

Complex Partical seizures since age 12. Right lobectomy in 1992, VNS Feb. 2003, removed Feb. 2004. I'll just keep trying.
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« Reply #2 on: October 22, 2008, 10:22:12 AM »

Event Date 01/01/2015
Event Type Injury
Manufacturer Narrative

Event Description
It was reported by a patient¿s mother that the vns side effects can be extreme. The reporter suggested that vns should only be tried in the worst cases and ¿seizures are better than death. ¿ the reporter expressed concern about the vns materials used.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4624809
« Last Edit: April 17, 2015, 11:08:52 PM by dennis100 » Logged
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« Reply #3 on: October 23, 2008, 01:20:59 AM »

Event Date 01/01/2011
Event Type Injury
Event Description
An anonymous vns patient reported that she had lost her voice for the past four years and was having worsening seizures and uncontrollable pain. The relationship of the patient¿s events to vns is unknown.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4623367
« Last Edit: April 17, 2015, 11:09:54 PM by dennis100 » Logged
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« Reply #4 on: October 23, 2008, 03:37:18 AM »

Model Number 104
Event Date 02/25/2015
Event Type Injury
Manufacturer Narrative

Event Description
It was reported that the vns patient was experiencing the following events which the physician believed were related to vns: congestive heart failure, stomach ulcers, tachycardia not associated with stimulation, dyspnea not associated with stimulation, and voice alteration. The physician elected not to disable the patient¿s device due to its effectiveness in reducing the patient¿s suicide attempts and depressive episodes. The physician noted that vns is not the source of these issues but believed that may be contributing to the patient¿s events. Attempts for additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4623006
« Last Edit: April 17, 2015, 11:10:46 PM by dennis100 » Logged
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« Reply #5 on: October 23, 2008, 04:24:17 AM »

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
« Last Edit: October 23, 2008, 04:50:56 AM by Birdbomb » Logged

"If you are going through hell, keep going." (Sir Winston Churchill, 1874-1965)
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« Reply #6 on: October 24, 2008, 03:01:38 AM »

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.

http://www.accessdata.fda.gov/scripts/cdrh...RFOI__ID=518958

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.

http://www.accessdata.fda.gov/scripts/cdrh...RFOI__ID=678928

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.

http://www.accessdata.fda.gov/scripts/cdrh...RFOI__ID=510117

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.

http://www.accessdata.fda.gov/scripts/cdrh...RFOI__ID=510233

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.

http://www.accessdata.fda.gov/scripts/cdrh...RFOI__ID=513687
« Last Edit: October 25, 2008, 03:53:44 AM by Bernard » Logged
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« Reply #7 on: October 24, 2008, 04:56:56 AM »

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[span style=\'color:green\']$[/color] but to other members and their dufus spokesmen Donney Wesley would chime in with the disclaimer.   It got to the point where people would post for Cyberionic$ 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. [/span]
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« Reply #8 on: October 24, 2008, 10:33:40 AM »

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.

http://www.accessdata.fda.gov/scripts/cdrh...RFOI__ID=245555

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).

http://www.accessdata.fda.gov/scripts/cdrh...RFOI__ID=841027
« Last Edit: October 25, 2008, 03:50:22 AM by Bernard » Logged
Bernard
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« Reply #9 on: October 25, 2008, 04:02:01 AM »

The FDA does not claim copyrights over their material, so it is OK to quote the reports.
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Check out this chart of alternative epilepsy treatments.
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« Reply #10 on: October 29, 2008, 11:11:45 AM »

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
« Last Edit: May 17, 2014, 06:54:47 AM by dennis100 » Logged
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« Reply #11 on: October 29, 2008, 11:37:19 PM »

<_< 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)
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« Reply #12 on: October 30, 2008, 01:39:23 AM »

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.
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« Reply #13 on: October 30, 2008, 04:43:55 AM »

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:
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« Reply #14 on: November 08, 2008, 01:24:50 PM »

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/cfdocs/cfmaude/detail.cfm?mdrfoi__id=643726
« Last Edit: May 17, 2014, 06:55:19 AM by dennis100 » Logged
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« Reply #15 on: November 08, 2008, 05:01:28 PM »

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:  
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« Reply #16 on: November 09, 2008, 01:38:12 PM »

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.accessdata.fda.gov/bbs/topics/NEWS/NEW00576.html

« Last Edit: October 22, 2012, 03:15:11 AM by dennis100 » Logged
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« Reply #17 on: November 09, 2008, 01:49:43 PM »

: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
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VNS implanted July 2007 for Epilepsy.  Activated August 2007.  No success, so VNS was turned off in August 2008 and COMPLETELY removed (including coils) on Nov 25, 2008.
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« Reply #18 on: November 10, 2008, 02:34:43 AM »

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/cfdocs/cfmaude/detail.cfm?mdrfoi__id=522645
« Last Edit: May 17, 2014, 06:59:21 AM by dennis100 » Logged
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« Reply #19 on: November 10, 2008, 09:03:43 AM »

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)
« Last Edit: November 10, 2008, 09:14:37 AM by Dispatch » Logged

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« Reply #20 on: November 10, 2008, 09:32:01 AM »

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
« Last Edit: May 17, 2014, 07:00:13 AM by dennis100 » Logged
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« Reply #21 on: November 11, 2008, 02:31:03 AM »

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%.
« Last Edit: November 11, 2008, 02:38:42 AM by dennis100 » Logged
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« Reply #22 on: November 11, 2008, 05:34:41 AM »

Keep in mind, Dennis, the current stats that Cyberonic[span style=\'color:green\']$ 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 $$$$[/span]
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"If you are going through hell, keep going." (Sir Winston Churchill, 1874-1965)
VNS implanted Sept 02, turned off Dec 04, Generator ex-planted Nov 07
Electrodes are in me for LIFE!
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« Reply #23 on: November 11, 2008, 09:59:16 AM »

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
« Last Edit: November 11, 2008, 10:01:32 AM by dennis100 » Logged
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« Reply #24 on: November 11, 2008, 12:57:33 PM »

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


 
« Last Edit: May 17, 2014, 07:01:38 AM by dennis100 » Logged
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« Reply #25 on: November 11, 2008, 04:16:20 PM »

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)
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VNS for TRD implant November, 2006.  Complete device removal including coils April, 2008.

"I reckon it's again my turn to win some or learn some..." Jason Mraz

ALL MY POSTINGS ON THE VNS MESSAGE BOARD ARE NON-TRANSFERABLE
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« Reply #26 on: November 12, 2008, 08:56:57 AM »

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
« Last Edit: November 12, 2008, 09:21:46 AM by dennis100 » Logged
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« Reply #27 on: November 12, 2008, 11:46:20 AM »

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
 
« Last Edit: May 17, 2014, 07:02:50 AM by dennis100 » Logged
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« Reply #28 on: November 12, 2008, 04:17:18 PM »

And what is a common answer when Cyberonics investigates themselves is "User Error".

Dispatch B)
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VNS for TRD implant November, 2006.  Complete device removal including coils April, 2008.

"I reckon it's again my turn to win some or learn some..." Jason Mraz

ALL MY POSTINGS ON THE VNS MESSAGE BOARD ARE NON-TRANSFERABLE
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« Reply #29 on: November 12, 2008, 10:52:03 PM »

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.
 
 
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