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dennis100
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« on: April 26, 2012, 01:14:12 PM »

Model Number 100
Event Date 07/11/2001
Event Type  Malfunction  
Manufacturer Narrative
Manufacturing records reviewed. Review of manufacturing records did not reveal any anomalies nor abnormalities that would have an adverse effect on device performance.
 
Event Description
Reporter indicated that patient's device stimulated constantly for approximately 20 minutes and that placing the magnet over the device did not help. This constant stimulation was reported as painful and went up the path of the lead to the neck. There was reported to be nothing in the environment that would cause this constant stimulation. Patient was seen by physician the day after the incident and the device communicated without incident. Patient reports that no other incident of this type have occurred.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=347288
« Last Edit: February 15, 2016, 10:30:06 PM by dennis100 » Logged
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« Reply #1 on: April 26, 2012, 01:15:27 PM »

Model Number 100
Event Date 01/23/2002
Event Type  Malfunction  
Patient Outcome  Hospitalization
Event Description
The emt called to say that they were transporting the pt to the emergency room because the device was continuously stimulating and was painful. The horseshoe magnet was taped to the device; however, the device was still stimulating. Multiple magnet orientations were used to try and turn the device off; however, the pt kept feeling the stimulation. The pt stayed the night in the hosp and the next morning the magnet was removed from the device and the pt had no further symptoms; the vns was cycling normally.
 
Manufacturer Narrative
Mfg records were reviewed. Review of the mfg records indicated that the device met all release specifications.
 
Manufacturer Narrative
In 1/2002, the pt went to the neurologist for an office visit. The pt was well (no continuous stimulation) but the neurologist adjusted his settings by lowering his output current from 2. 0ma to 1. 75ma. In 2/2002, the neurologist adjusted the pt's settings back to 2. 0ma 5 minutes off time, and magnet stimulation was set for 2. 25ma. In 3/2002, the pt reported that he no longer felt continuous stimulation. In 3/2002, the pt was seen by the neurologist and reported that he has been having good seizure control and has no complaints about the device. The neurologist changed the signal off time from 5 minutes to 3 minutes. A lead test was ran and resulted in an ok impedance (dc-dc code 3). The pt reported that the device has mad an overall improvement in his life.
 
Manufacturer Narrative
Method: device programming history was reviewed. Results: review of programming history did not reveal any anomalies nor abnormalities.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=379915
« Last Edit: February 15, 2016, 10:31:38 PM by dennis100 » Logged
dennis100
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« Reply #2 on: April 26, 2012, 01:16:02 PM »

Model Number 101
Event Date 01/04/2002
Event Type  Malfunction  
Manufacturer Narrative
Further follow-up with physician revealed that the pt is no longer experiencing the same symptoms of pain or difficulty with his device settings that were initially reported. Physician cited pt confidentiality and would give no further detail regarding how the event came to be resolved.
 
Manufacturer Narrative
Method: programming history was reviewed. Mfg records were reviewed. Results: no abnormalities or deficiencies were noted in the programming history or in the mfg records for the device. Attempts to gather further info regarding this event have been unsuccessful to date.
 
Event Description
Reporter indicated that patient's device seemed to be cycling more frequently than what it is programmed to. The patient believed that the device was programmed to an off time of 5 minutes, but that it was cycling randomly and more frequently than that. Patient reported that the pt experienced some discomfort and hoarseness after the implant surgery that has since completely resolved. Patient does not experience hoarseness during stimulation. Patient reported that the pt woke up at approximately 1:00am because the pt felt the device stimulating more frequently than the pt was used to. The pt tried to stop stimulation by placing the pt's magnet over the device, but the stimulation would not stop. The device is implanted subcutaneously as recommended in device labeling and the magnet works properly to activate stimulation. The pain was described as being 4 or 5 inches below the adam's apple in the pt's neck, directly in the center of the neck. It was reported that there was no discomfort, pain or discoloration at the generator site or at the electrode site. The patient stated that the pt is prone to infection because the pt has had the spleen removed. The patient stated that the pt was not near anything that might cause electro-magnetic interference. The pt has moved and has not found self a new neurologist yet. Pt's previous physician reported that the pt was last seen in their office in 11/01 at which time a parameter adjustment was made. The pt has not contacted their office since then.
 
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=375790
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« Reply #3 on: April 27, 2012, 01:06:16 AM »

Model Number 101
Event Date 05/01/2002
Event Type  Malfunction  
Manufacturer Narrative
The generator was returned and analyzed. No anomalies were identified via external visual inspection. A pre-implant test was performed which reulted in an ok impedance (dc-dc code 2), indicating proper device function. The elective replacement indicator was no, indicating that the generator was not at end of service. The pulse generator met final electrical test specifications. No anomalies were identified that could have an adverse effect on device performance. No anomaly was identified that could potentially cause or contribute to the reported malfunction. The lead was also returned and analyzed, although there is no lead malfunction reported. No discontinuities were identified on the lead assembly returned. The condition of the lead is consistent with conditions that exist after the explant procedure. No anomaly was identified that could potentially cause or contribute to the reported malfunction.
 
Event Description
Reporter indicated that patient's ncp system (both generator and lead) was explanted due to suspected device malfunction. The patient reported that the device was "constantly firing". No x-rays were taken prior to explant surgery. Device programming history has been requested, but has not been received for review. Attempts to obtain additional information have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=407773
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« Reply #4 on: April 27, 2012, 01:06:44 AM »

Model Number 101
Event Date 05/17/2002
Event Type  Malfunction  
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records did not reveal any anomalies nor abnormalities that would have an adverse effect on device performance.
 
Event Description
Reporter indicated that patient's normal mode output current was increased from 0. 75ma to 1. 0ma and magnet mode output current was increased from 1. 25ma to 1. 5ma at office visit in 2002. Three days later, the patient reported that they could not tolerate the higher settings. The physician recommended that the patient tape their magnet over the device to temporarily stop stimulation until the patient could be seen in the office again. The patient reported that the device seemed to be continuously stimulating while the magnet was taped over it. The patient was seen by physician 11 days later, who reduced both the normal mode and magnet mode output current back to previous settings. The patient is reportedly doing fine following these parameter adjustments. The physician was unsure whether the patient had securely taped the magnet over the device when trying to temporarily stop stimulation. If the magnet was not securely taped over the device, it is possible that the patient may have inadvertently activated the device (like a magnet swipe) with normal movement. Attempts to obtain additional information have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=403021
« Last Edit: February 15, 2016, 10:33:33 PM by dennis100 » Logged
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« Reply #5 on: April 27, 2012, 04:34:17 AM »

Model Number 100
Event Date 11/18/2002
Event Type  Malfunction  
Patient Outcome  Life Threatening,Required Intervention,Hospitalization
Manufacturer Narrative
Report is incomplete because attempts to contact patient's treating neurologist have been unsuccessful to date. H. 6. Method: device manufacturing records were reviewed. Results: review of manufacturing records for both the pulse generator and the bipolar lead revealed no anomalies that would adversely effect device performance.
 
Event Description
Reporter indicated that patient was hospitalized for seizures and that the patient is experiencing dizziness, continuous stimulation, and a tingling feeling at the left neck and chest areas. The patient indicated that it felt as if the device was stuck in an on position, but that pt used the magnet and the symptoms stopped. It is believed that the patient's generator may be nearing normal end of service, but investigation to date has been unable to rule out the vns as the cause of the hospitalization.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=434924
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« Reply #6 on: April 27, 2012, 01:12:31 PM »

Model Number 102
Event Date 04/23/2003
Event Type  Malfunction  
Manufacturer Narrative
H. 6. : device manufacturing records were reviewed. Review of manufacturing records for both the pulse generator and the bipolar lead revealed no anomalies that would adversely effect device performance.
 
Event Description
Reporter indicated that pt experienced 45 minutes of continuous stimulation while working at their home computer and that the cybermagnet would not stop stimulation. Pt described the feeling as "needles in their chest" and the muscles in their neck were contracting. It was also reported that the pt now feels a burning by the generator site when the device stimulates. Device diagnostic testing was within normal limits, indicating proper device function. It was reported that during office visit, the cybermagnet was placed over the device for approximately 10 minutes and the device would not stop stimulating as evidenced by pt's continued voice changes. Magnet mode stimulation was initiated as expected when device was swiped with magnet. The pt's device was programmed to off with plans to initiate stimulation again at a later date at very low settings. Treating neurologist plans to stimulate the pt more often to see if it can be determined whether or not the generator is continuously stimulating. Further follow-up revealed that the pt's device was programmed back to on and that the device was stimulating according to programmed parameters. The pt was reportedly tolerating the stimulation well. Investigation to date has been unable to determine whether or not the device is functioning properly.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=462509
« Last Edit: February 15, 2016, 10:34:57 PM by dennis100 » Logged
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« Reply #7 on: April 28, 2012, 03:24:50 AM »

Event Date 08/31/2003
Event Type  Malfunction  
Manufacturer Narrative
Report is incomplete because attempts to obtain additional info have been unsuccessful to date. No response has been received to mfr's requests for additional info from initial reporter.
 
Event Description
Vns pt was seen in the er complaining of pain due to continous stimulation. It was reported that placing the magnet over the device was unsuccessful in stopping stimulation. The pt indicated that their device was "reprogrammed" two days prior. Investigation to date has been unable to determine whether or not the device had malfunctioned.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=486742
« Last Edit: February 15, 2016, 10:35:17 PM by dennis100 » Logged
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« Reply #8 on: April 28, 2012, 03:25:15 AM »

Event Date 07/23/2003
Event Type  Malfunction  
Manufacturer Narrative
Report is incomplete because no response has been received to mfr's requests for add'l info from treating neurologist. H. 6. : vns therapy system labeling states that failure to make a good electrical connection to the pulse generator can result in a lead test failure or erratic stimulation at varying intensity due to rapid, unpredictable changes in lead impedance, which is expected to adversely affect device effectiveness and may have serious safety consequences.
 
Event Description
Reporter indicated that vns pt was experiencing erratic stimulation. The pt reportedly experienced 45 minutes of continuous stimulation that was at a higher level than programmed normal mode and magnet mode output current. It was reported that the pt experienced severe pain and was unable to speak clearly during the erratic stimulation. The pt denies being around any strong magnetic fields. The magnet was placed over the device to temporarily discontinue stimulation. Device diagnostic testing was within normal limits. The pt's device was reset and the pt was monitored for one hour afterwards. Device reset appears to have resolved the issue. Investigation to date has been unable to determine the cause of the reported erratic stimulation.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=480326
« Last Edit: February 15, 2016, 10:35:35 PM by dennis100 » Logged
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« Reply #9 on: April 28, 2012, 03:25:44 AM »

Model Number 101
Event Date 01/01/2003
Event Type  Malfunction  
Manufacturer Narrative
Report is incomplete because no response has been received to manufacturer's requests for additional info from treating neurologist. H. 6. : device manufacturing records were reviewed. Review of manufacturing records for both the pulse generator and the bipolar lead revealed no anomalies that would adversely affect device performance.
 
Event Description
Reporter indicated that pt's device has been turning "on" and "off" randomly for a few months. It was reported that the device sometimes comes "on" all day and then nothing. The pt is reportedly not around any strong magnets, just regular household appliances.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=479235
« Last Edit: February 15, 2016, 10:35:51 PM by dennis100 » Logged
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« Reply #10 on: April 28, 2012, 03:26:13 AM »

Event Date 04/01/2003
Event Type  Injury  
Patient Outcome  Life Threatening
Manufacturer Narrative
H. 6 the vns therapy system labeling lists dyspnea (difficulty breathing, shortness of breath) as a potential adverse event possibly associated with surgery or stimulation.
 
Event Description
On two occasions, the device stimulated and "felt like it was stuck". The pt reported that they could not get their breath and that they felt like their heart was "going" to stop". The pt placed the magnet over the device to deactivate the stimulation. The pt is still experiencing approximately 6-7 seizures per week.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=474990
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« Reply #11 on: April 28, 2012, 03:26:45 AM »

Model Number 102
Event Date 12/01/2011
Event Type Malfunction
Event Description
Additional information was received indicating that the patient's generator has been replaced. Diagnostics before and after generator replacement were normal. Per hospital policy, the explanted generator will not be returned. An implant card was received indicating the replacement was prophylactic.

Event Description
It was reported that the vns patient was experiencing erratic stimulation. Diagnostics taken indicated normal vns function. No medication or programming changes were noted as possible contributing factors. The patient felt that the stimulation was coming on more frequently than programmed. Troubleshooting with a manufacturer representative was not able to confirm the event, however the physician believes that there is a malfunction with the device. The physician indicated he would be referring the patient for replacement. Attempts for additional information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2437355
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« Reply #12 on: April 28, 2012, 03:27:20 AM »

Event Type  Injury  
Patient Outcome  Life Threatening,Required Intervention
Manufacturer Narrative
Report is incomplete because pt's family member requested that mfr not contact treating physician. No pt info was provided for further follow-up at the time of the initial report. H. 6. Ncp system labeling lists heart rate/rhythm changes as a potential adverse event possibly associated with surgery or stimulation.
 
Event Description
Pt is experiencing painful stimulation, but the device was programmed to off over a year ago. It was reported that the pt's device continues to stimulate even after being programmed to off. It was also reported that the pt experienced decreased heart rate (64 bpm) when the device was on. The pt's hands reportedly turned purple and cold during these episodes. It was reported that the pt's heart rate decreased further (40 bpm) after the device was programmed to off. Treating neurologist reportedly does not believe that the pt's symptoms are related to the vns. Cardiologist has reportedly inquired about when the vns would be explanted as they reportedly believed that the pt's symptoms could be related to the device. It was reported that the cardiologist instructed the pt to drink gatorade which seemed to help. Reporter also indicated that the pt had a tumor in their neck.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=500268
« Last Edit: February 15, 2016, 10:38:42 PM by dennis100 » Logged
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« Reply #13 on: April 28, 2012, 03:28:06 AM »

Model Number 102
Event Date 10/01/2003
Event Type  Malfunction  
Manufacturer Narrative
H. 6. Device manufacturing records were reviewed. Device programming history was reviewed. Review of manufacturing records for both the pulse generator and the bipolar lead revealed no anomalies that would adversely effect device performance. No anomalies were noted during review of programming history.
 
Event Description
Reporter indicated that vns patient experienced a 1 1/2 hour episode during hwich their generator stimulated constantly. It was reported that the patient's voice was "raspy" during the episode as when normal stimulation occurs and that the patient experienced pain at the base of their neck. The patient was asymptomatic when seen by neurologist after the episode. Device interrogation revealed no anomalies in programmed parameters and device diagnostic testing was within normal limits. Further follow-up revealed that the patient was not around any kind of magnetic field or mri machine at the time of the event. The neck pain subsided when the episode of constant stimulation stopped. There has reportedly been no increase in seizures since the event. The patient reportedly used their magnet to temporarily discontinue stimulation at which time the neck pain subsided. The patient feels that the episodes are related to their visits to the local hospital because each episode occurred after a visit to the hospital.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=494822
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« Reply #14 on: April 29, 2012, 12:21:18 AM »

Model Number 102
Event Date 05/12/2004
Event Type  Malfunction  
Manufacturer Narrative
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. Vns therapy system labeling states that the safety and efficacy of therapy have not been systematically established for uses in pt with history of previous therapeutic brain surgery.
 
Event Description
Rptr indicated that pt's device was "continuously firing" for 30 to 40 mins. The pt was seen in hosp er. The er physician indicated that the only way he knew that the device was continuously stimulating is by what the pt was telling him. A vns therapy programming system was not available in the hosp er. The er physician indicated that he would place the pt's magnet over the device to stop stimulation.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=594304
« Last Edit: February 15, 2016, 10:39:24 PM by dennis100 » Logged
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« Reply #15 on: April 29, 2012, 04:12:33 AM »

Model Number 101
Event Date 06/01/2004
Event Type  Malfunction  
Manufacturer Narrative
Report is incomplete because no response has been received to manufacturer's requests for device settings and programming history. Ncp system labeling lists dyspnea (shortness of breath) as a potential adverse event possibly associated with surgery or stimulation. Ncp system labeling states that in the unlikely event of uncomfortable adverse events, continuous stimulation, or other malfunction, the pt must be advised to hold or tape the magnet directly over the implanted pulse generator to prevent additional stimulation. If pts or care givers find this procedure necessary, they should immediately notify the pt's physician. Additionally, labeling states that application of the magnet during stimulation will exhibit the output. In addition, holding the magnet in place for at least 65 seconds will prevent the initiation of a magnet mode stimulation and will terminate any ongoing normal mode stimulation. After the magnet is removed, normal mode operation will resume with stimulation when one complete off time has elapsed. In the unlikely event of continuous stimulation or other malfunction, the pt must be advised to apply the magnet, secure it in place, and immediately notify his or her physician.
 
Event Description
Pt underwent generator replacement surgery due to suspected device malfunction. At office visit with neurologist, the pt reported that the generator did not seem to be stimulating when it should. Neurologist referred that pt to neurosurgeon for follow up. Treating neurosurgeon indicated that device diagnostic testing was "fine", but did not specifically state the dc-dc code or whether the elective replacement indicator was yes or no. The next evening, the pt was seen in hosp emergency room due to sporadic stimulation with shortness of breath. The pt reported that the device stimulated for four hours straight and that placing the magnet over the device did not stop stimulation. The pt underwent generator replacement surgery the following day. Review of manufacturing records for the pulse generator revealed no anomalies that would adversely effect device performance. Analysis of returned pulse generator did not reveal any anomalies that would contribute to the alleged malfunction. External visual inspection revealed no anomalies and the device met electrical test specifications. The elective replacement indicator was no, indicating that the generator had not reached end of service.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=612052
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« Reply #16 on: April 29, 2012, 04:12:58 AM »

Model Number 101
Event Date 06/21/2004
Event Type  Malfunction  
Manufacturer Narrative
Review of mfg records for both the pulse generator and the bipolar lead revealed no anomalies that would adversely affect device performance. Investigation to date has been unable to rule out device malfunction. Report is incomplete because no response has been received to manufacturer's requests for additional information from treating neurologist (via fax x2).
 
Event Description
Vns pt was seen in hosp emergency room due to continuous device stimulation. The pt has reportedly used their magnet to initiate magnet mode stimulation 10 times that day because they were having some seizures and afterwards, they felt as if the stimulation would not stop. The continuous stimulation reportedly lasted for 20 minutes. The pt reported that the continuous stimulation was not painful, but fell like a tingling and numbness in their throat. The pt reported that when the magnet was placed over the device to temporarily discontinue stimulation, the device began cycling normally but did not stop stimulating. Emergency room physician reported that the magnet was taped on to the pt's chest when they arrived, but that it appeared to be a bit low in relation to the generator area and that this could have been the reason that stimulation did not stop. While at the hosp emergency room, the pt's generator appeared to be working normally and did not continuously stimulate. It was reported that the pt manipulates the device through the skin.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=611971
« Last Edit: February 15, 2016, 10:40:04 PM by dennis100 » Logged
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« Reply #17 on: April 29, 2012, 01:07:27 PM »

Model Number 101
Event Date 07/01/2004
Event Type  Malfunction  
Event Description
Reporter indicated that vns pt experienced an episode of continous stimulation. It was reported that the pt was attending a barbeque function at a country club and immediately experienced continuous device stimulation upon entering a particular room. The pt knew that the device was continuously stimulating because pt was coughing and they experienced voice alteration during that time. Attempts to discontinue stimulation with the magnet were unsuccessful. The pt was reportedly only in the room for a short time and when they left the room, the device stopped continuously stimulating. The pt reported that there was a large barbeque pit in the room and that there were magnets on the doors.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=612027
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« Reply #18 on: April 29, 2012, 01:07:54 PM »

Model Number 102
Event Type  Malfunction  
Manufacturer Narrative
Review of mfg records records for both the pulse generator and the bipolar lead revealed no anomalies that would adversely affect device performance. Report is incomplete because no response has been received to mfr's request for additional info from treating neurologist. (via 1fax, 1 phane call).
 
Event Description
The reporter indicated that they think their generator is stimulating more than the programmed 5 minute duration. The reporter indicated that their generator has been stimulating continously for about 10-15 minutes. The reporter also stated that they had a seizure and the magnet was used which helped the seizure subside. Their vns settings were adjusted one week before the event. The pt has scheduled a follow-up visit with their neurologist.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=612146
« Last Edit: February 15, 2016, 10:40:43 PM by dennis100 » Logged
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« Reply #19 on: May 02, 2012, 02:27:28 AM »

Model Number 102
Event Date 08/16/2004
Event Type  Malfunction  
Patient Outcome  Hospitalization
Manufacturer Narrative
Review of manufacturing records for both the pulse generator and the bipolar lead revealed no anomalies that would adversely affect device performance. Report is incomplete because the patient does not have a current treating neurologist and they are in the process of finding one. The previous neurologist was contacted and he reports that he is no longer seeing this patient due to insurance reasons. H6: vns therapy system lists dyspnea (difficulty breathing, shortness of breath) as a potential adverse event possibly associated with surgery or stimulation. The event is currently under investigation.
 
Event Description
Reporter indicated that they were feeling "electrical surges" and experiencing erratic stimulation. The reporter also indicated that they were experiencing pain in the area of their pulse generator, and shortness of breath. The patient was subsequently admitted to the hospital. The patient indicated that the device was shocking them. At that time, the generator settings were decreased. Vns system diagnostic testing was performed and showed the device was delivering therapy; however, the magnet activations were not displaying. After the patient's settings were decreased, the patient no longer felt electrical surges, but the patient had seizures. X-rays were performed and didn't show any apparent anomalies. The generator was replaced. Vns system diagnostic testing was performed immediately prior to surgery and resulted in proper generator function. During generator replacement surgery no anomalies were noted with the replaced generator and the lead. The generator was programmed on to the same settings prior to the event.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=612049
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« Reply #20 on: May 02, 2012, 02:28:06 AM »

Model Number 102
Event Date 01/01/2004
Event Type  Malfunction  
Manufacturer Narrative
Review of manufacturing records for both the pulse generator and the bipolar lead revealed no anomalies that would adversely affect device performance.
 
Event Description
Reporter indicated that vns patient experienced an episode of continuous device stimulation after a lightning strike. It was reported that lightning struck about a block away from where the patient was and that the patient's device subsequently began continuously stimulating. The patient's spouse reportedly secured the magnet over the device to temporarily discontinue stimulation. After a couple of hours, the magnet was removed from the device and normal device stimulation resumed. Treating neurologist indicated the device diagnostic testing was within normal limits and that device interrogation was successful. Device interrogation revealed that programmed parameters were as prescribed. Neurologist indicated that the patient was "crazy" and that the patient was doing fine.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=611929
« Last Edit: February 15, 2016, 10:41:28 PM by dennis100 » Logged
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« Reply #21 on: May 02, 2012, 02:28:47 AM »

Model Number 102
Event Date 09/01/2003
Event Type  Injury  
Patient Outcome  Life Threatening,Required Intervention
Manufacturer Narrative
Report is incomplete because no response has been received to mfr's requests for additional info from treating neurologist (via fax x1).
 
Event Description
The vns therapy exacerbated the pt's myoclonic jerks and that normal mode output current had subsequently been programmed to off for more than a year. Magnet mode output current was still active, but the pt reportedly never used their magnets to initiate magnet mode stimulation. While the pt was at school recently, they experienced a coughing spell, after which the device reportedly stimulated erratically. It was reported that the pt's device seemed to be stimulating about every ten minutes, as evidenced by the pt's jerking reaction. The pt had reportedly been in their normal environment. Magnet mode stimulation was subsequently programmed to off as a result of the recent erratic stimulation episode. Additionally, the pt's family member reported a previous episode where review of magnet activation history revealed more magnet activations that were initiated by the pt. It was reported that the additional magnet activations occurred during the night while the pt was asleep. When asked what was done to resolve the situation, the family member indicated that "it just went away. " there are no plans to re-initiate device stimulation. Pt's family member reports that all events have resolved since magnet mode stimulation was programmed to off. Pt's family member plans to eventually have the device explanted. Review of mfg records for both the pulse generator and the bipolar lead revealed no anomalies that would adversely effect device performance. Investigation to date has been unable to determine whether the device was functioning properly.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=548368
« Last Edit: February 15, 2016, 10:41:51 PM by dennis100 » Logged
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« Reply #22 on: May 02, 2012, 02:29:17 AM »

Model Number 102
Event Date 09/13/2004
Event Type  Malfunction  
Manufacturer Narrative
Review of manufacturing records for both the pulse generator and the bipolar lead revealed no anomalies that would adversely effect device performance. Investigation to date has been unable to determine whether the device was functioning properly.
 
Event Description
Reporter indicated that vns pt experienced "shooting electrical current" through their body after doing some heavy lifting earlier in the day. It was reported that the pt complained to the point of screaming that their device was shooting electrical current all across their chest and into their neck, causing constant sore throat and leading spouse to beleive that they were going to die. The pt's chest was described as being "red like if someone poured hot water on pt" and the pt was short of breath with difficulty swallowing during the episode. It was also reported that the pt had "red blisters" on their chest and that the pt experienced pain in their stomach and the bottom of their feet. The pt's spouse indicated that the pt has a history of heart problems and that spouse planned to sue the manufacturer if the pt died as a result of the shocking sensation. It was reported that the shocking stopped when the pt placed the magnet over the device. The pt was seen by treating neurologist who programmed the device to off. The device was successfully interrogated, but no diagnostic testing was performed because the pt was excessively belligerent to the point that the physician had to call security. It was reported that the pt had not experienced significant efficacy with the vns therapy prior to the incident. Treating neurologist does not believe that the device is malfunctioning and indicated that the pt has psychological issues. The device was later explanted at the pt's request.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=612042
« Last Edit: February 15, 2016, 10:42:08 PM by dennis100 » Logged
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« Reply #23 on: May 02, 2012, 02:29:53 AM »

Model Number 101
Event Date 11/01/2004
Event Type  Malfunction  
Event Description
Further follow-up revealed that the patient underwent generator replacement surgery. During the surgery, device diagnostic testing was within normal limits and had no cardiac effects. The pulse generator was then disconnected from the bipolar lead and a new generator was connected to the existing lead. Subsequent lead tests were within normal limits and had no cardiac effects. The patient left the operating room with the device programmed to off. The patient reported that the device was initially programmed to off due to what patient believed to be an arrhythmia. The cause of the reported events is most likely due to device stilumlation because the patient's symptoms resolved when the device was programmed to off.
 
Event Description
Further follow-up revealed that the patient's arrhythmia began approximately on year following implant. Epileptologist indicated that the arrhythmia was related to vns therapy. Epileptologist reported that the patient's symptom were continous and that the symptoms have resolved with ncp system replacement. The cause of the reported event cannot be ascertained because the explanted generator will not be returned to device manufacturer for analysis per the explanting hospital's policy.
 
Event Description
Reporter indicated that vns pt was hospitalized due to continuous device stimulation for more than 4 hours. The pt experienced coughing, tightness and pain in their chest during the continuous stimulation episode. It was reported that the pt's magnet was taped over the device to discontinue stimulation. The pt's symptoms reportedly subsided when stimulation was temporarily discontinued with the magnet. Device diagnostic testing was reportedly with normal limits, indicating proper device function. The elective replacement indicator was no, indicating that the generator had not reached end of service. Further follow-up revealed that just prior to the reported continuous stimulation episode, the pt hit their left shoulder, causing them pain on left side of their neck with stimulation. Treating neurologist reportedly decreased normal mode output current from 2. 25ma to 1. 0ma, but the patient's pain did not subside. The pt's device was subsequently programmed to off later that same day.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=612054
« Last Edit: February 15, 2016, 10:42:35 PM by dennis100 » Logged
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« Reply #24 on: May 02, 2012, 02:30:29 AM »

Model Number 102
Event Date 03/27/2005
Event Type  Malfunction  
Manufacturer Narrative
Report is incomplete because no response has been received to mfr's requests for add'l info from treating neurologist. Vns therapy system labeling lists worsening of asthma/bronchitis as a potential adverse event possibly associated with surgery or stimulation. Vns therapy system labeling states that the safety and efficacy of this therapy have not been systematically established for use in pts with history of respiratory diseases or disorders, including dyspnea and asthma.
 
Event Description
Vns pt's device was "running on its own" for two days, causing the pt unbearable pain. The pt was hospitalized for unk reasons at the time of the initial report. Pt had become accustomed to normal mode stimulation and did not usually feel it, but that for two days, the device began stimulating continuously (for up to 5 mins at a time). The pt reported that when they secured the magnet over the generator to discontinue stimulation, the device continued to stimulate continuously. The pt planned to follow-up with neurologist for device diagnostic testing. Review of mfg records for both the pulse generator and the bipolar lead revealed no anomalies that would adversely affect device performance. Investigation to date has been unable to determine whether the device was functioning properly.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=598575
« Last Edit: February 15, 2016, 10:42:55 PM by dennis100 » Logged
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« Reply #25 on: May 02, 2012, 02:31:02 AM »

Model Number 102R
Event Date 03/01/2005
Event Type  Malfunction  
Event Description
Review of the manufacturing records for the pulse generator revealed no anomalies that would adversely affect device performance.
 
Manufacturer Narrative
Report is incomplete because no response has been received to manufacturer's requests for additinal information from treating neurologist (via telephone x3, via fed-ex x1).
 
Event Description
Reporter indicated that vns pt's device was stimulating erratically, causing the pt to have part in their chest. It was reported that the pt's device was stimulating every 2 seconds for a couple of days. The pt planned to follow-up with their neurologist. Programmed parameters were last adjusted approx one month prior to the erratic stimulation event. Review of the manufacturing records for the bipolar lead revealed no anomalies that would adversely affect device performance. Investigation to date has been unable to determine whether the device is functioning properly.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=588160
« Last Edit: February 15, 2016, 10:43:15 PM by dennis100 » Logged
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« Reply #26 on: May 02, 2012, 02:31:46 AM »

Model Number 102
Event Date 02/01/2005
Event Type  Injury  
Patient Outcome  Life Threatening
Event Description
Reporter indicated that vns pt experienced a recent increase in seizure activity. It was reported that the pt experience 5 seizures in a 48-hour period and that this was not their normal seizure pattern. Device diagnostic testing was within normal limits, indicating proper device function. X-rays reviewed by treating ent surgeon did not reveal any obvious discontinuities in the vns therapy system;however, some tension in the lead wire was noted. Exploratory surgery is planned. Review of manufacturing records for both the pulse generator and the bipolar leas revealed no anomalies that would adversely effect device performance. Investigation to date has been unalbe to determine the cause of the reported increase in seizure activity.
 
Event Description
The explanted products have not been returned to manufacturer for analysis; therefore, the cause of the reported events cannot be determined.
 
Manufacturer Narrative
Six months after revision surgery the pt reported pain in their jaw and left ear with device stimulation and occassional incidents of feeling device stimulation travel down their arm and to their chest/stomach, causing them to gag. The pt reported that the pain was not as bad as it had previously been before the revision surgery and was tolerable. It was reported that the symptoms resolved after a reduction in programmed pulse width from to 250u to 130u but approx six months later, the pt reported feeling constant stimulation and an increased surge of stimulation every 5 minutes, at which time pt felt a shooting pain to their head and right shoulder. Occasionally, when pt turned their head to the left pt experienced a shooting pain to their chest and then down to their stomach. The pt reported that this pain resolved when pt turned her head back to a forward position and that "pt could live with it" as it was only an occasional occurence. Device diagnostic testing at that time was within normal limits, indicating proper device function. Normal mode output current was decreased from 1. 5 a to 1. 25 ma, after which the pt denied any discomfort. Follow-up one month later revealed that the pt continues to complain of feeling jolts and pain down her neck, arm and shoulder and sometimes her stomach. The pt was referred to a gi physician and an ent to rule out causes other than the vns therapy system due to the fact that the symptoms are sporadic.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=578485
« Last Edit: February 15, 2016, 10:43:44 PM by dennis100 » Logged
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« Reply #27 on: May 02, 2012, 02:33:09 AM »

Model Number 101
Event Date 05/19/2001
Event Type  Injury  
Patient Outcome  Life Threatening,Required Intervention,Hospitalization
Event Description
Pt had vagus nerve stimulator implanted at the recommendation of neurologist. Within two weeks after it was activated, it started to malfunction. Such as, the pulse in some instances was so strong that looked like a "bolt of lightning" incidents, right leg flexed for the full 30 seconds of the generator pulse, pt happened to be driving their truck at the time. Their right leg flexing caused them to press the accelerator to the floor and run off the end of the road on a dead end street. Pt's right hip was damaged so badly that it had to be replaced. Pt's left shoulder was re-assembled with several screws in addition to several other injuries.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=557771
« Last Edit: February 15, 2016, 10:44:16 PM by dennis100 » Logged
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« Reply #28 on: May 03, 2012, 02:48:32 AM »

Model Number 101
Event Date 04/01/2005
Event Type  Injury  
Patient Outcome  Life Threatening,Required Intervention,Hospitalization
Manufacturer Narrative
Due to an administrative error, the suspect product (pulse generator) information reported in the initial mdr was incorrect.
 
Manufacturer Narrative
H. 6. The vns therapy system is indicated for use as an adjunctive therapy in reducing the frequency of seizures in adults and adolescents with partial onset seizures that are refractory to antiepileptic medications. In the united states, the vns therapy system is approved for use in adults and adolescents with partial onset seizures that are refractory to antiepileptic medications.
 
Event Description
Reporter indicated that vns pt has recently experienced an increase in seizure activity above pre-vns baseline frequency. Device diagnostic testing was reportedly within normal limits, indicating proper device function. Based on known device settings, the generator battery should already have reached normal end of life. It was reported that the pt had recently undergone an eeg and that treating neurosurgeon believed that the generator may be stimulating erratically. The pt underwent generator replacement surgery due to end of battery life. The pt was reportedly not having any more seizures after generator replacement surgery. Based on information obtained to date, it appears that the increase in seizure activity was a result of normal end of battery life; however, it is not know why the seizure activity increased above pre-vns baseline frequency.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=610758
« Last Edit: February 15, 2016, 10:45:32 PM by dennis100 » Logged
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« Reply #29 on: May 03, 2012, 02:49:10 AM »

Model Number 101
Event Date 08/01/2005
Event Type  Injury  
Patient Outcome  Life Threatening
Event Description
Reporter indicated that vns patient was experiencing sporadic stimulation that sometimes caused chest pain and pain in the neck area. Device diagnostic testing was within normal limits, indicating proper device function. The elective replacement indicator was no, indicating that the generator battery had not reached end of life. Based on known device settings, remaining generator battery life was estimated to be approximately 1. 09 years. Investigation to date has been unable to determine whether the chest pain is cardiac-related as no response has been received to manufacturer's request for additional information from treating neurologist.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=638687
« Last Edit: February 15, 2016, 10:45:53 PM by dennis100 » Logged
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