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Is the FDA doing its job?

By Rob Stein

A new report is renewing questions about the Food and Drug Administration's oversight of medical devices.

In a paper published in the British medical journal known as BMJ, investigative journalist Jeanne Lenzer and Shannon Brownlee of the Dartmouth Institute for Health Policy and Clinical Practice raise questions about the FDA's oversight, citing a device manufactured by Cyberonics, Inc., of Houston.

The device, known as a vagus nerve stimulator (VNS), is implanted under the skin and sends electrical impulses to stimulate the vagus nerve in the neck. It was approved in 1997 to prevent epileptic seizures on the condition that the company that Cyberonics carry out a post-approval study to examine the safety of the device. The company conducted a study, but did not include any information about deaths among patients who received the device, according to the report. In the 13 years since the device was approved 900 deaths have been reported, according to the report.

Lenzer and Brownlee say the device typifies the FDA's lax oversight of medical devices. In an editorial accompanying the paper, Jerry Avorn of Harvard Medical School calls on the FDA to strengthen its oversight of medical devices. Avorn said the agency should develop better ways to monitor their safety.

This is far from the first time questions have been raised about the safety of medical devices. In fact, in 2005 the FDA itself evaluated its post-approval studies and found more than one-fifth "couldn't be evaluated for quality because there was no record at the FDA showing they had ever been conducted," according to the report. The FDA has "since automated its records but many companies continue to submit data deemed 'inadequate' by the agency, while other studies remain unreported."

Cyberonics defended the safety of its device in a written statement, saying "VNS Therapy is an important treatment option for patients with epilepsy who have tried and failed multiple medications and for whom brain surgery is not an option." The company also said that none of the 900 deaths reported to the FDA were attributed to the device and that in fact patients who use the device are less likely to die than those who do not.

In a telephone interview, Karen Riley, a spokesperson for the FDA, agreed that there was no evidence that any of the 900 deaths were caused by the device, adding that the company's follow-up study also did not find any signs the device was causing any problems. Moreover, the agency had taken a number of steps in recent years to improve the monitoring of products after they had been approved, she said.

By Rob Stein  | November 3, 2010; 7:00 AM ET
Categories:  FDA, Obesity  
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Comments

The truth is "hate speech" only to those who have something to hide.--Michael Rivero

First they ignore it, then they laugh at it, then they say they knew it all along. --Alexander Humbold

TRUTH to be told. Cyberonic$ can defend this thing all it wants but the fact is over 60% of those implanted are HARMED by vns. Can a drug company get away with that? And those deaths, Most had NO autopsy so cause of death was guessed. VNS caused late on-set cardiac problems in people who NEVER had cardiac problems in their lives. Read the MAUDE Reports for yourself, do more research, talk to those who have lived in this nightmare.

Posted by: DGB2 | November 3, 2010 4:04 PM | Report abuse

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/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=522043

Posted by: dennisfegan | November 3, 2010 6:52 PM | Report abuse

Event Date 03/03/2008
Event Type Injury Patient Outcome 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.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1022608

Posted by: dennisfegan | November 3, 2010 6:54 PM | Report abuse

Event Date 01/01/2006
Event Type Injury Patient Outcome 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.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=675911

Posted by: dennisfegan | November 3, 2010 7:12 PM | Report abuse

Event Date 01/01/2007
Event Type Injury Patient Outcome Required Intervention; Hospitalization Life Threatening
Event Description
Reporter indicated that the pt was admitted to the hosp for pulmonary problems following a vns replacement. Follow-up with physicians indicated that the pt experienced bradycardia, hypotension, and respiratory failure which required cardiac life support and hospitalization. X-rays reviewed by mfr did not reveal any anomalies. The pt experienced four more instances of bradycardia, hypotension, and a decrease in breathing rate which initially required temporary disablement of the vns with a magnet and finally resulted in programming the device off. It was reported that the pt was hospitalized for all four of these events. The pt's events have resolved since the vns has been turned off. The physicians indicated that "almost with 100% certainty that this is related to vns" and that the device will not be explanted.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=842295

Posted by: dennisfegan | November 3, 2010 7:44 PM | Report abuse

Event Date 01/01/2009
Event Type Injury Patient Outcome Required Intervention; Hospitalization
Event Description
It was reported that a pt developed drop attacks in 2009 (approximately 7. 5 years after being implanted which lead to the pt being hospitalized. The pt also had periodic bradycardia. The device was programmed off and the bradycardia and drop attacks resolved. Additional information received from the pt's physician revealed that the pt does not have a history or a family history of cardiac events. The pt presented with syncope which suggested some sort of arrhythmia. The pt's heart rate prior to the event was 70 and decreased to 10 during the event. The blood pressure was 120/80 prior to the event; however, no blood pressure readings were provided after the event. There were no traumatic events, medication changes, or triggers such as smoking, caffeine intake, etc. That preceded the onset of the bradycardia. The pt is currently taking zonegran, lamictal, and topamax. The bradycardia did not occur during device diagnostics nor did it occur following a setting change. An ecg and polysomnography were performed to diagnosed the arrhythmia. The arrhythmia (bradycardia) is believed to be related to device stimulation and is exaggerated by the device. The pt was hospitalized for the length of testing needed to diagnose the arrhythmia. The arrhythmia has not recurred since the device has been programmed off. Good faith attempts to obtain additional information are currently being made.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1558273

Posted by: dennisfegan | November 3, 2010 7:52 PM | Report abuse

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/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=613869


Posted by: dennisfegan | November 4, 2010 6:05 AM | Report abuse

Event Type Injury Patient Outcome Life Threatening; Hospitalization
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/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=245555

Posted by: dennisfegan | November 4, 2010 6:25 AM | Report abuse

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/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=841027

Posted by: dennisfegan | November 4, 2010 6:41 AM | Report abuse

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/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1091663

Posted by: dennisfegan | November 4, 2010 6:58 AM | Report abuse

Holy crap I knew the FDA was a joke but this is staggering in it's audacity. The FDA is a sham agency totally owned by big pharma down to the doorknobs and rugs. I know most in the medical community look to Europe in deciding whether a drug or medical device is safe. So this article really isn't a surprise.

For budget cutting the FDA should be at the top of any closure list. It long ago lost it's ability to protect the US public. Sadly the VNS is just another example of how bad things are today.

Posted by: Desertdiva1 | November 4, 2010 3:45 PM | Report abuse

They really did a number on Nephros.

Posted by: truth34 | November 4, 2010 6:20 PM | Report abuse

Model Number 100
Event Date 08/27/1999
Event Type Injury Patient Outcome Life Threatening; Required Intervention
Event Description
Although the pt was receiving a reduction in seizures, she requested the device be removed. She stated that the stimulation "bothered her. " her physician scheduled an appointment to make some adjustments to her device. Subsequently, the pt took some sterile equipment from an area hosp and removed the device at home. The pt was instructed by her neurologist to go to the emergency room. The pt's wound was treated in the emergency room; a drain was put in place, and the wound was stitched.


http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=241087

Posted by: dennisfegan | November 5, 2010 7:44 AM | Report abuse

Event Date 01/11/2002
Event Type Injury Patient Outcome Hospitalization; Required Intervention
Event Description
Rptr indicated that pt had explanted self. It was reported that the pt went into the restroom and when the pt came out, the generator was out of the pt's chest. The pt opened the healed incision. The pt had apparently pried the generator out with the pt's hands. The pt picked at it until the pt got it out. The pt's lead was explanted by surgeon and the pt was prescribed a prophylactic ten-day dose of amoxicillin. There are no plans for re-implant. Further f/u revealed that the pt was seen in 2002 at which time the pt's staples were removed and the pt was reported to be healing fine from the explant procedure. No further appointments are scheduled.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=377618

Posted by: dennisfegan | November 5, 2010 7:48 AM | Report abuse

Event Date 07/28/2009
Event Type Injury Patient Outcome Required Intervention;
Event Description
Reporter indicated a vns therapy pt "decided to remove the battery himself. He literally removed the battery including the leads", and the incision became infected. The physician did not know the pt removed the vns therapy system. The pt's family reports the pt "has been doing strange things", since his medications were changed. Mfr records confirmed device sterility prior to shipment. The explanted vns therapy system has been returned to the mfr and is pending analysis. Good faith attempts to obtain add'l info have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1463630

Posted by: dennisfegan | November 5, 2010 8:06 AM | Report abuse

Event Date 01/01/2004
Event Type Injury Patient Outcome Required Intervention;
Event Description
Patient's wound dehisced some time after suture removal following implant surgery. The patient was reportedly seen in hospital emergency room, at which time the wound was "sewn back up. " at recent office visit, treating neurologist indicated that he could not palpate the generator. Review of subsequent chest x-ray revealed that no generator was present in the chest along with no evidence of the lead. Investigation to date has been unable to determine the location of the devices or whether the patient removed the lead and/or generator through the incision sites. The patient's family member has reportedly searched their home for the lead and generator with no success. Repeat x-rays and follow up with neurosurgeon are planned. Investigation to date has been unable to determine the cause of the reported wound dehiscence.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=573008

Posted by: dennisfegan | November 5, 2010 8:10 AM | Report abuse

Event Date 01/01/2004
Event Type Injury Patient Outcome Required Intervention;
Event Description
It was reported that the pt experienced psychosis in 2004 which was believed to be directly related to stimulation. The physician indicated that the pt's seizures were well-controlled by vns, however, the pt had psychotic episodes involving the desire to kill his parents. The physician indicated that the device was programmed off and the psychosis subsided. At a later date, the physician wanted to program the pt's vns device back on, however, the mother was adamant that it not be turned on due to the harm the pt may try to cause her.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1667284

Posted by: dennisfegan | November 5, 2010 9:07 AM | Report abuse

Event Date 07/01/2008
Event Type Injury Patient Outcome Hospitalization; Required Intervention
Event Description
Reporter indicated a vns pt "developed intractable psychosis after the use of a vns device for treatment of his refractory epilepsy". Although he had a prior history of psychotic illness, the episode reported here was significantly more severe in terms of the content of the delusions, the tenacity with which they were maintained, the explosive violence and the refractoriness to antipsychotic medication. The improvement in his condition following each reduction in vns pulse intensity was swift and dramatic. Good faith attempts to obtain additional info have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__ID=1186054

Posted by: dennisfegan | November 5, 2010 9:11 AM | Report abuse

Event Date 09/01/2003
Event Type Injury Patient Outcome Life Threatening; Disability
Event Description
Reporter indicated that vns patient has become psychotic and believes that radio waves from the device are controlling them. The patient had been scratching and digging at the device in their chest. The patient was hospitalized and their device was programmed to off. Anti-psychotic medications were prescribed. It is believed that this may be a case of forced normalization since the patient had become seizure-free very quickly. The patient was discharged after their behavior settled down a bit. The ncp system remains programmed to off. The patient is reportedly still seizure-free and although they are more rational now, they are still demanding that the ncp system be explanted.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=489964

Posted by: dennisfegan | November 5, 2010 9:16 AM | Report abuse

Event Date 01/01/2006
Event Type Injury Patient Outcome Required Intervention;
Event Description
Reporter indicated that he started experiencing manic episodes approx 1 month following the implant of the vns therapy system. Reporter stated he was then prescribed lithium by his dr, and that the mania subsided with the daily use of this medication.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=836404

Posted by: dennisfegan | November 5, 2010 9:20 AM | Report abuse

Event Date 09/03/2009
Event Type Injury Patient Outcome Required Intervention;
Event Description
It was reported that a pt would have the device explanted due to psychosis. Good faith attempts to obtain additional info from the pt's physician have been unsuccessful to date. No programming or device diagnostic history is available in the in-house database. The pt's generator has been explanted and returned to the mfr and proper functionality of the pulse generator in its ability to provide appropriate programmed output currents can be verified. There were no performance or any other type of adverse conditions found with the pulse generator. The pulse generator performed according to specifications.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1502162

Posted by: dennisfegan | November 5, 2010 9:24 AM | Report abuse

Event Date 01/01/2008
Event Type Injury Patient Outcome Required Intervention;
Event Description
It was reported by the physician in 2009, that the patient has been hearing voices and hallucinating for about six months, which she feels the patient now needs psychiatric treatment. The physician noted that just prior to the onset of the hallucinations, the patient's device was increased from 1. 75 ma to 2. 0 ma output current. The physician indicated that there have been no known medication changes, but is now on medication for the hallucinations. It was also noted that the patient is experiencing outside stressors, but it is unknown if they are contributing to her recent hallucinations. The physician said she is unsure if the hallucinations are related to the vns therapy, but she does not want to disable the device since the patient is doing well with seizure control. It is unknown at this time what the relationship of the hallucinations is to that of the device and therapy. There is no suspected device failure at this tim

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1375271

Posted by: dennisfegan | November 5, 2010 9:33 AM | Report abuse

Event Date 06/01/2008
Event Type Injury Patient Outcome Other;
Event Description
Initial reporter indicated that the pt had manic episodes after the device was turned on about two weeks after implant in 2008. Physician stated that "pt had no previous psychiatric history. Family reported that pt has high elevated moods (being too happy) and had uncontrollable giggling and laughing. " additionally, reported "when pt first came into the appointment, he was quite reserved, but after awhile he was being quite talkative and kept on saying he's 1 years old. " pt was at 0. 25ma, 30, 500, 30sec, 5min, magnet 0. 5ma, 500 and so physician turned the device to 0ma. After that, the pt calmed down and slept a lot. A week later, the physician turned pt back up to 0. 25, 30, 500, 30sec, and 20 min off. The pt is reported to be doing fine currently.


http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1098144

Posted by: dennisfegan | November 5, 2010 9:46 AM | Report abuse

The fda has its problems but I won't be so quick to throw cyberonics under the bus. The patients who receive the implant often have severe problems and turned to vns after medication has failed. I have recommended this device to several of my patients, and those who receive the implant have experienced positive results. The device isn't perfect but to say its killing people is childish and illogical. To say it is responsible for those deaths would be like saying a hospital is responsible for all the people that pass in it. Most of the people who receive the device are in bad shape to begin with. Dont blame cyberonics just because your looking for someone to blame.

Posted by: Wmarshalh | November 5, 2010 8:45 PM | Report abuse

The fda has its problems but I won't be so quick to throw cyberonics under the bus. The patients who receive the implant often have severe problems and turned to vns after medication has failed. I have recommended this device to several of my patients, and those who receive the implant have experienced positive results. The device isn't perfect but to say its killing people is childish and illogical. To say it is responsible for those deaths would be like saying a hospital is responsible for all the people that pass in it. Most of the people who receive the device are in bad shape to begin with. Dont blame cyberonics just because your looking for someone to blame.

Posted by: Wmarshalh | November 5, 2010 8:45 PM | Report abuse

The fda has its problems but I won't be so quick to throw cyberonics under the bus. The patients who receive the implant often have severe problems and turned to vns after medication has failed. I have recommended this device to several of my patients, and those who receive the implant have experienced positive results. The device isn't perfect but to say its killing people is childish and illogical. To say it is responsible for those deaths would be like saying a hospital is responsible for all the people that pass in it. Most of the people who receive the device are in bad shape to begin with. Dont blame cyberonics just because your looking for someone to blame.

Posted by: Wmarshalh | November 5, 2010 8:45 PM | Report abuse

The fda has its problems but I won't be so quick to throw cyberonics under the bus. The patients who receive the implant often have severe problems and turned to vns after medication has failed. I have recommended this device to several of my patients, and those who receive the implant have experienced positive results. The device isn't perfect but to say its killing people is childish and illogical. To say it is responsible for those deaths would be like saying a hospital is responsible for all the people that pass in it. Most of the people who receive the device are in bad shape to begin with. Dont blame cyberonics just because your looking for someone to blame.

Posted by: Wmarshalh | November 5, 2010 8:46 PM | Report abuse

The fda has its problems but I won't be so quick to throw cyberonics under the bus. The patients who receive the implant often have severe problems and turned to vns after medication has failed. I have recommended this device to several of my patients, and those who receive the implant have experienced positive results. The device isn't perfect but to say its killing people is childish and illogical. To say it is responsible for those deaths would be like saying a hospital is responsible for all the people that pass in it. Most of the people who receive the device are in bad shape to begin with. Dont blame cyberonics just because your looking for someone to blame.

Posted by: Wmarshalh | November 5, 2010 8:46 PM | Report abuse

The fda has its problems but I won't be so quick to throw cyberonics under the bus. The patients who receive the implant often have severe problems and turned to vns after medication has failed. I have recommended this device to several of my patients, and those who receive the implant have experienced positive results. The device isn't perfect but to say its killing people is childish and illogical. To say it is responsible for those deaths would be like saying a hospital is responsible for all the people that pass in it. Most of the people who receive the device are in bad shape to begin with. Dont blame cyberonics just because your looking for someone to blame.

Posted by: Wmarshalh | November 5, 2010 8:48 PM | Report abuse

The fda has its problems but I won't be so quick to throw cyberonics under the bus. The patients who receive the implant often have severe problems and turned to vns after medication has failed. I have recommended this device to several of my patients, and those who receive the implant have experienced positive results. The device isn't perfect but to say its killing people is childish and illogical. To say it is responsible for those deaths would be like saying a hospital is responsible for all the people that pass in it. Most of the people who receive the device are in bad shape to begin with. Dont blame cyberonics just because your looking for someone to blame.

Posted by: Wmarshalh | November 5, 2010 8:49 PM | Report abuse

Event Date 09/07/2007
Event Type Malfunction Patient Outcome Other
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.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1009251

Posted by: dennisfegan | November 6, 2010 10:01 AM | Report abuse

Event Date 05/01/2006
Event Type Injury Patient Outcome Required Intervention
Event Description
Reporter indicated that pt began to experience episodes of syncope and asystole approximately six years post vns implant. The pt reported feeling the need to cough, after which he reportedly lost consciousness. Approximately two months after, the onset of symptoms, the pt was hospitalized for eval of the syncope episodes, at which time and ekg revealed episodes of asystole that coincided with device stimulation cycles; however, not every stimulation cycle would produce this event. The vns therapy system was then programmed to off, after which a repeat ekg was normal. The pt did not experience any further episodes of syncope or asystole in the absence of the vns therapy. Eval by cardiologist did not reveal any abnormalities with the pt's heart. The device remains programmed to off. Both the cardiologist and the neurologist believe that the reported events were caused by the stimulation of the vagus nerve. There had been no recent changes to programmed device settings; however, inderal had recently been added to the pt's medication regimen for treatment of mild hypertension.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1629932

Posted by: dennisfegan | November 6, 2010 10:05 AM | Report abuse

Event Date 12/04/2008
Event Type Injury Patient Outcome Life Threatening; Required Intervention
Event Description
It was reported in a scientific article that a vns patient, who had been receiving vns therapy for nine years without complaint, was admitted to the hospital for the control of an episode status epilepticus, an event not uncommon for the patient, for which medication was administered. The patient experienced an increase in seizures during the hospital stay and eeg monitoring revealed the occurrence of periodic cardiac changes with bradyarrhythmia and often severe asystolia due to atrium ventricular block, which coincided with stimulation. The patient was admitted to the cardiac intensive care unit and underwent holter monitorization, because the periodicity of the bradyarrhythmias was the same as that of the ncp stimulation (around 30 s every 5. 5 min), the ncp was stopped. Once the device was disabled, the reported arrhythmia event resolved. The reporter states that though there appears to be a clear relationship to vns therapy, other contributing factors were believed to be present. These factors include the addition of levetiracetam, which had a notable arrhythmic effect on the patient. The author also suggests that the patient's status episode may have predisposed the patient to the vns-related cardiac arrhythmia.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1276878

Posted by: dennisfegan | November 6, 2010 10:06 AM | Report abuse

Event Date 03/13/2010
Event Type Injury Patient Outcome Required Intervention;
Event Description
It was initially reported that a pt was having episodes of bradycardia with a heart rate in the 30s and was also experiencing a few episodes of asystole (each about 5 seconds in duration). The cardiologist thought it may possibly be related to the pt's vns device. A company rep went to the pt's next appt and was unable to interrogate the pt's device due to believed end of service. A battery life calculation was performed using the pt's programming history available in the in-house database (current from date of implant to (b) (6) 2009) and it was found that the device may be at end of service. Good faith attempts to obtain add'l info have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1658341

Posted by: dennisfegan | November 6, 2010 11:28 AM | Report abuse

Event Date 01/01/2004
Event Type Injury Patient Outcome Required Intervention
Event Description
Further follow-up (discharge summay dated 2004) revealed that the pt originally received the vns system so that he coul reduce the medications he was taking. The vns did not appear to help, and the pt reportedly began to have recurring and more-frequent events. The pt reported that 80% of the seizures are without warming and 20% are preceded by the sensation of jejavu. The pt feels "generally not right" and has difficulty breathing. He will suddenly stop what he is doing and become pale. His lips will turn blue and he will fall from standing. He denies any convusions. The episodes last 20-30 seconds, sometimes accompanied by brief myoclonus and followed by postictal confusion of 1-20 minutes. There is frequent urinay incontinence but rarely bowel incontinence. The pt was admitted to the impatient monitoring svc to better identify and classify his events for the initial evaluatio of possible surgical intervention. The pt was placed on continuous video-eeg monitoring. He had normal waking background alpha frequency of 11 hz with normal drowsiness and sleep stages identified. The pt had normal, if any, identifable interictal epileptiform discharges. He had several clinical events recorded. The pt had an event where he went from his prior sinus heart rate to a progressive bradycardia,culminating in a 15-second pause that was followed by generalized flattering of the eeg background, followed by some generalized delta events. After this event a cardiology consult was obtained. This was the event that prompted the initial medwatch report. There was concern that the vns system may have contributed to the event, therefore, the vns device was deactivated. Because the pt had the vns device for quite sometime before the asystole event, it was felt by the epilepsy svc to be exceedingly unlikely that the vns device contributed to the episode of asystole. Following the initial event, the pt had several more events, though none were accompanied by significant asystole. It was reported that the episode of asystole may have been triggered by a subtle seizure activity involving the frontal lobe, and there was no way to guarantee that this would not recur. The vns device was not turned back on at this point and it is unk if the vns device is presently activated.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=566648

Posted by: dennisfegan | November 6, 2010 11:30 AM | Report abuse

The FDA does simply a wonderful job....if you are a drug maker attempting to get poison approved to sell as drugs to the consumer.

Posted by: GitBackJoJo | November 6, 2010 4:50 PM | Report abuse

Better off just getting rid of the FDA and getting a lowlife like Snoop Dog to test and approve your drugs.

Posted by: GitBackJoJo | November 6, 2010 4:54 PM | Report abuse

To Wmarshalh

Posting the same ignorant post over and over is pretty childish and illogical. What are you trying to prove? Your new ability to C&P? Get off my internets.

Just how much money have you made from this device? Those kickbacks from Cyberonics must be exceptional. Tell me, How does it feel to sell your soul to the devil?

VNS never caused any death directly or indirectly? That's like saying shooting someone in the heart with a .38 doesn't kill them, it's that silly little hole the body makes from the bullet, silly body.

I know for a FACT that vns has been a direct cause of death. Just because the manufacturer denies vns has directly caused deaths, doesn't make their statement true. How many rapists in prison claim they never raped? Bill (lied under oath) Clinton never had sex with that woman! Who can forget Bernie Madoff as an Investment Advisor and Oh and this juicy one...Janet Cooke, a Washington Post journalist won a Pulitzer Prize for a story called 'Jimmy's World," about an 8-year-old heroin addict. The only trouble was that she had created the entire story out of thin air.

Something Cyberonics cannot tell, the truth, or the answers to these questions...
How many units have been deactivated
How many units have been explanted
How can a company determine a CAUSE OF DEATH?
How much is paid to doctors for each active unit.
How many more deaths are UNREPORTED?
How many more deaths are UNREPORTED?
How many more deaths are UNREPORTED?
How many more deaths are UNREPORTED?
How many more deaths are UNREPORTED?
How many more deaths are UNREPORTED?
How many more deaths are UNREPORTED?

Posted by: DGB2 | November 6, 2010 7:59 PM | Report abuse

I am the Dennis Fegan mentioned in the BMJ article. I have spent months reading all of the Cyberonics reports in the FDA adverse events databank (MAUDE). I've categorized and posted a number of them on the VNS Message Board. I would suggest to anyone who is interested in the subject to log on to the site and look in the Legislative Activism section. Check out the Unexplained Deaths, Heart Stoppages (asystole) and Bradycardia reports for starters. You can decide for yourself whether or not the Vagus Nerve Stimulator is a deadly device.

Posted by: dennisfegan | November 7, 2010 6:31 AM | Report abuse

DGB2, what facts do you have that vns kills people? Also, I get no kickbacks and I will continue to prescribe the implant until I see some actual research that would convince me not to. I have had several patients tell me that vns has liberated them from their disorder. I want to see solid evidence, not theoritical accusations.

Posted by: Wmarshalh | November 8, 2010 10:47 AM | Report abuse

DGB2, what facts do you have that vns kills people? Also, I get no kickbacks and I will continue to prescribe the implant until I see some actual research that would convince me not to. I have had several patients tell me that vns has liberated them from their disorder. I want to see solid evidence, not theoritical accusations.

Posted by: Wmarshalh | November 8, 2010 10:48 AM | Report abuse

DGB2, what facts do you have that vns kills people? Also, I get no kickbacks and I will continue to prescribe the implant until I see some actual research that would convince me not to. I have had several patients tell me that vns has liberated them from their disorder. I want to see solid evidence, not theoritical accusations.

Posted by: Wmarshalh | November 8, 2010 10:49 AM | Report abuse

DGB2, what facts do you have that vns kills people? Also, I get no kickbacks and I will continue to prescribe the implant until I see some actual research that would convince me not to. I have had several patients tell me that vns has liberated them from their disorder. I want to see solid evidence, not theoritical accusations.

Posted by: Wmarshalh | November 8, 2010 10:56 AM | Report abuse

DGB2, what facts do you have that vns kills people? Also, I get no kickbacks and I will continue to prescribe the implant until I see some actual research that would convince me not to. I have had several patients tell me that vns has liberated them from their disorder. I want to see solid evidence, not theoritical accusations.

Posted by: Wmarshalh | November 8, 2010 10:56 AM | Report abuse

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