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Author Topic: Increase/Worsening of Seizures  (Read 772010 times)
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dennis100
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« Reply #30 on: November 23, 2011, 03:52:53 PM »

Model Number 100
Event Date 06/13/2000
Event Type Injury Patient Outcome Life Threatening; Hospitalization Required Intervention
Event Description
Rptr indicated that on event date, pt had a violent 18 minute seizure. The magnet was used at the onset of the seizure. The pt vomited and aspirated into their lungs resulting in adult respiratory distress. Pt was hospitalized for three months. Pt spent the first month in neuro-critical care, the second month in the respiratory unit being weaned off of the ventilator, and the third month in therapy to regain strength and weight pt had lost. Also while in the hosp, the pt developed a bleeding ulcer and needed 6 units of blood. In 2000, just 6 weeks after being home, the exact same seizure pattern occurred. The magnet was again used at seizure onset. The pt again vomited and aspirated, but a vacu-aide suction machine was used and eliminated a great deal from entering the lungs. Pt was again hospitalized for another 6 weeks and placed on a ventilator. The physician decreased the device output current to 0. 75 the following month while pt was still in hosp. The magnet has not been used at seizure onset. There have been no more incidents of this nature. There have been many seizures, but no life-threatening aspiration.

Manufacturer Narrative
Method: mfg records were reviewed. Results not review of the mfg records did not identify any anomalies or abnormalities that would have an adverse effect on device performance. Two written requests and three phone calls were made to gather further info; however, the info was not rec'd.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=355868
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dennis100
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« Reply #31 on: November 23, 2011, 03:53:26 PM »

Model Number 101
Event Date 09/01/2001
Event Type Injury Patient Outcome Life Threatening; Required Intervention
Event Description
Reporter indicated that patient suffered from 7 grand mal seizures within a two-week period. It was reported that the patient did not have a history of grand mal seizures, but the frequency had increased. Both programming parameter adjustments and medication changes took place before, during and after this time.

Manufacturer Narrative
Method: manufacturing records reviewed. Results: review of manufacturing records did not reveal any anomalies nor abnormalities that would have an adverse effect on device performance.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=364396

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dennis100
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« Reply #32 on: November 23, 2011, 03:54:54 PM »

Event Date 10/01/2001
Event Type Malfunction
Manufacturer Narrative
The following dates are estimated. Only the month/year is known: b. 3, date of event.

Event Description
Reporter indicated that high lead impedance reading was obtained during lead test at office visit in 11/2001 (dc-dc code 7 and limit). It was also reported that the patient has had an increase in seizures over the past month and that the eri (elective replacement indicator) flag was obtained due to normal end of service or whether there may be a lead break.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=364767
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dennis100
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« Reply #33 on: November 23, 2011, 03:55:51 PM »

Model Number 100
Event Date 09/01/2001
Event Type Injury Patient Outcome Life Threatening;
Event Description
Reporter indicated that over the past six weeks, the pt has begun to have an increase in seizures. Medication changes have not improved the seizure control. The pt has never really felt hoarseness; however, the pt does feel stimulation, specifically magnet mode. Attempts to obtain add'l info have been unsuccessful. Investigation has been unable to determine the severity of the seizures.

Manufacturer Narrative
The dr reported that the pt was having spells of eye pain which the parents were interpreting as seizures. An eeg confirmed no correlation between the eye pain and actual seizures. Changing the medication resolved the eye pain. The pt is currently doing fine. Event not related to device.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=361613
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dennis100
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« Reply #34 on: November 23, 2011, 03:56:32 PM »

Model Number 101
Event Date 01/01/2001
Event Type Injury Patient Outcome Life Threatening;
Manufacturer Narrative
Following a change in parameters it was reported that the pt was no longer experiencing an increase in seizures or cluster seizures. Device programming history reviewed. Review of programming history did not reveal any evidence of device malfunction.

Manufacturer Narrative
Mfg records reviewed. Review of mfg records did not reveal any anomalies nor abnormalities that would have an adverse effect on device performance.

Event Description
Reporter indicated that pt has had an increase in drop seizures and status since the vns implant. Over the past several months the pt goes several days without seizures then will have 4-5 drop seizures in one day. It was reported that the seizures are more intense since the vns implant. Pt experienced an epsiode of status for two days in 2001 which resulted in a trip to the emergency room. Pt experienced an episode of status 9 days later which resolved by itself. No changes in medications (trileptol and tegretol) have been made since implant.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=361678

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dennis100
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« Reply #35 on: November 23, 2011, 03:57:47 PM »

Model Number 100
Event Date 01/01/2001
Event Type Injury Patient Outcome Hospitalization;
Manufacturer Narrative
Device manufacturing records were reviewed. Review of device manufacturing records did not reveal any anomalies nor abnormalities that would have an adverse effect on device performance.

Event Description
Reporter indicated that the battery in the pt's device went dead after only 6 months. It was reported that the pt's seizures were reduced after implant from 9-10 per day to 3-4 per day, but that their seizure frequency increased after a few months. These seizures resulted in hospitalization of the pt on numerous occasions. It was reported that the magnet no longer aborted the pt's seizures and that the pt stopped having hoarseness and coughing with stimulation. The generator was replaced. Further investigation revealed that the pt had been implanted for approx 19 months before they began losing seizure control and that the pt is non-compliant. It was reported that the pt's dilantin levels range from 4-44 and that the pt is frequently seen in the emergency room because pt either does not take their medication or takes too much.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=367887

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dennis100
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« Reply #36 on: November 23, 2011, 03:58:36 PM »

Model Number 300-20
Event Date 03/26/2001
Event Type Malfunction
Event Description
Initial report indicated that patient complained of severe burning to the left neck. Review of x-rays did not reveal any anomalies nor abnormalities. In 04/01, the patient stated that they did not experience any more painful episodes. Further investigation revealed that parameter reduction appeared to have alleviated the patient's pain. It was later reported that high lead impedance result was obtained during lead test and normal mode test in 11/01 (dc-dc code 6). At this visit, the patient stated that they could no longer feel stimulation, no longer experienced voice alteration with stimulation, and did not feel the magnet stimulation. Eri (elective replacement indicator) flag was "no", indicating that device was not at end of service. It was also reported at this time that the patient had experienced an increase in seizures since april 2001. The increase in seizures and high lead impedance reading indicated possible lead break.

Manufacturer Narrative
Further follow-up revealed that the patient may have experienced trauma to the chest or neck area during physical therapy. The physician reported that the patient device was programmed to off on 10/02/2002 due to severe buringing sensation in the patient's neck

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=368828

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dennis100
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« Reply #37 on: November 23, 2011, 03:59:27 PM »

Model Number 100
Event Date 11/17/2001
Event Type Death Patient Outcome Death;
Manufacturer Narrative
The physician indicated that there was no relationship between the ncp system and the cause of death.

Manufacturer Narrative
Method: manufacturing records reviewed. Results: 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 the patient's device had reached end of service several months ago. It was reported that approximately three months ago the physician documented in the patient's file that he was not as alert and had an increase in seizures. It was reported that a lead test was never done. Further investigation revealed that the patient was found face down on the floor with their head in a pillow. It appeared that the patient had a seizure. The prelimnary autopsy was inconclusive, however there were no signs of suffocation.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=367255

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dennis100
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« Reply #38 on: November 23, 2011, 04:00:09 PM »

Model Number 100
Event Date 01/01/2001
Event Type Injury Patient Outcome Required Intervention;
Manufacturer Narrative
Further follow-up revealed that the pt's increase in seizures and insomnia were better after programming the device to off.

Manufacturer Narrative
Mfg records reviewed. Review of mfg records did not reveal any anomalies nor abnormalities that would have an adverse effect on the device performance.

Event Description
Reporter indicated that the pt was programmed to off at the one year follow up visit because of an increase in seizures. The pt could not fall asleep. The pt was worse in alertness, verbal communication, memory, school achievements and mood changes. Further investigation revealed that the pt experienced periods of improvement following deactivation of device. An offer was presented to reactivate the device, however, the family has decided against reactivation at this time.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=365069

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dennis100
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« Reply #39 on: November 23, 2011, 04:02:45 PM »

Model Number 101
Event Date 01/15/2002
Event Type Injury Patient Outcome Life Threatening;
Manufacturer Narrative
Device mfg records were reviewed. Review of device mfg records did not reveal any anomalies nor abnormalities that would have an adverse effect on device performance.

Event Description
Rptr indicated that pt experienced an electric shock while the pt was at work that ran up the pt's left arm. After the shock, the pt experienced several cluster seizures. It was reported that prior to this event, the pt's seizures had been well controlled with the ncp system. Two attempts have been made to obtain add'l info (1 via certified u. S. Mail to physician and 1 via telephone conversation with physician's receptionist) with no response to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=377565
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dennis100
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« Reply #40 on: November 23, 2011, 04:03:51 PM »

Model Number 100
Event Date 01/01/2002
Event Type Injury Patient Outcome Life Threatening;
Manufacturer Narrative
Method: device mfg records were reviewed. Device programmed history was reviewed. Results: review of device mfg records did not reveal any anomalies nor abnormalities that would have an adverse effect on device performance. Review of device programming history confirmed that the generator had reached normal end of service. Conclusion: normal end of service.

Event Description
Reporter indicated that data transmission error was received while trying to interrogate pt's device. Common troubleshooting techniques did not resolve the situation. Attempts to reset the device were unsuccessful. It was reported that the pt has experienced an increase in seizures, but that pt does feel a little tingle with stimulation. Physician believes that the device is at end of service. Further f/u revealed that the pt was violent during their episodes of increased seizures and that pt had actually hurt someone resulting in a hospital visit for that person.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=378032

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dennis100
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« Reply #41 on: November 23, 2011, 04:04:48 PM »

Model Number 100
Event Date 11/01/2001
Event Type Injury Patient Outcome Life Threatening; Required Intervention
Event Description
Initial reporter indicated that the patient began to experience excessive drooling with a lot of mucus. It was reported that when the drooling type seizures occur, use of the magnet appears to worsen the seizure. Further investigation revealed that the patient also had difficulty swallowing medication due to the drooling problem. Reporter later indicated that the pulse width setting and the signal frequency were both adjusted on 10/2001. Reporter also indicated that during the seven weeks after this adjustment the drooling did not improve nor did their swallowing problems but their grand mal seizures increased. Reporter indicated that after the seven weeks the pulse width setting and the signal frequency were both adjusted back to the original settings. Reporter also indicated that patient is now experiencing grand mal seizures every other day. An attempt to follow-up with the patient's physician was made on 02/2002 but the nurse practitioner refused to reveal any information regarding the patient due to patient confidentiality.

Manufacturer Narrative
Mfg records were reviewed. Review of the mfg records did not reveal any anomalies nor abnormalities that would have an adverse effect on device performance. Further follow-up indicated that the pts drooling has continued. The ncp system was tested by the physician and was found to be operating appropriately. The use of the magnet is not helpful with the pt's tonic seizures. The pt's parent claims they use to be able to stop the tonic seizures with the magnet.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=376094

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dennis100
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« Reply #42 on: November 23, 2011, 04:05:38 PM »

Model Number 100
Event Date 10/01/2001
Event Type Injury Patient Outcome Life Threatening;
Manufacturer Narrative
Further follow-up revealed that the pt is currently doing fine and having good seizure control since generator replacement surgery. Physician indicated that the increase in seizures was due to the generator nearing end of service. Available programming history was reviewed. Review of available device programming history revealed that eri (elective replacement indicator) flag was no, indicating that the generator was not at end of service (diagnostic testing dated 1/9/2002).

Event Description
Reporter indicated that the patient has experienced an increase in seizures over the last few months. Reporter indicated that the patient's neurologist felt that the device need to be replaced due to end of service. Further investigation on 02/2002 revealed that patient's generator was replaced on 01/2002 because it was no longer working.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=376212

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dennis100
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« Reply #43 on: November 23, 2011, 04:06:23 PM »

Model Number 101
Event Date 01/01/2002
Event Type Injury Patient Outcome Life Threatening; Hospitalization
Manufacturer Narrative
Manufacturing records reviewed. Code 100: review of manufacturing records did not identify any anomalies or abnormalities that would have an adverse effect on device performance. The following dates are estimated. Only the month/year is known: b. 3, date of event.

Event Description
Reporter indicated that patient had been admitted to the hospital twice in the past week for seizures. The patient has experienced great seizure control since implant up until being hospitalized for seizures as reported. Patient's family member denied any injury or trauma.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=375953

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dennis100
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« Reply #44 on: November 23, 2011, 04:07:54 PM »

Event Date 12/21/2001
Event Type Malfunction
Patient Outcome Life Threatening; Hospitalization
Manufacturer Narrative
Further follow-up revealed that testing of the ncp system indicated that the device was reducing the number of seizures that the pt experienced. It was reported that the pt underwent a brain scan (date unk) which revealed that the pt's left hemisphere was deformed/abnormal and that it appeared to be shrinking. The pt underwent brain surgery (date unk) and has mad a remarkable recovery. The ncp system remains programmed to on. The pt's seizure activity is greatly reduced following the brain surgery. It was reported that the pt almost sleeps through the night now and is not experiencing any further problems. It was reported that the pt is more aware of her surroundings, is more attentive, comprehends more, and is progressing in the mental capacity. The physician indicated that improper technique may have been a factor in the magnet not working to abort the pt's seizures. Physician would not provide device programming history or any further info as he did not feel it was relevant due to opinion that event was not device-related and that there was no device malfunction. It was reported that the pt still has seizures, but that her seizure frequency had been reduced by 45%. Physician indicated that he did not believe that the event was related to the ncp system.

Event Description
Reporter indicated that the patient has experienced an increase in seizures beginning in 2001. The seizure activity is noted only at night while the patient is sleeping. It was reported that the magnet is no longer stopping the seizures. The patient was seen in the emergency room one week later with seizures occurring every thirty minutes. The patient was released with instructions to follow-up with the pt's physician. Two days later, the patient has seizures all night long and was unable to sleep.

Manufacturer Narrative
Two attempts to obtain additional information were made via telephone conversation with new physician's nurse. Physician was out of the office at the time of the first attempt. At the time of the second attempt, the physician's nurse stated that she would have someone return co's call. Patient is in transition of health care providers and has not yet been seen by a new physician.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=375263

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dennis100
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« Reply #45 on: November 23, 2011, 04:08:52 PM »

Model Number 300
Event Date 12/20/2001
Event Type Malfunction
Manufacturer Narrative
Programming history reviewed. Review of programming history revealed that on 12/20/2001, normal mode test indicated the device could not deliver the prescribed parameters. A lead test was also ran and was within normal limits which indicates the device is not malfunctioning.

Manufacturer Narrative
Two attempts have been made to obtain complete device programming history (1-via u. S. Mail to physician, 1-via telephone message to physician's office). Review of available device programming history revealed that lead test resulted in dc-dc code 1 and ok, indicating no lead malfunction at that time. Interrogation of device revealed that the eri (elective replacement indicator) was "no", indicating that the generator was not nearing end of service. The following dates are estimated. Only the month/year is known: d. 7, implant date.

Event Description
Reporter indicated that lead test at office visit resulted in high lead impedance reading (dc-dc code 7 and limit), indicating a possible lead malfunction. It was reported that the patient has had limited benefit from the "vns"; however, the patient has recently experienced an increase in seizures. It was reported that the patient has not fallen or had any trauma to the chest area and that the patient can feel the stimulation. Lead test at office visit resulted in normal lead impedance reading (dc-dc code 1). Physician plans to see how the patient does at next scheduled appointment in approximately 10 weeks from the time of the initial report.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=375545

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dennis100
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« Reply #46 on: November 23, 2011, 04:09:38 PM »

Model Number 101
Event Date 12/01/2001
Event Type Injury Patient Outcome Hospitalization;
Manufacturer Narrative
The following dates are estimated. Only the month/year is known: b. 3, date of event.

Event Description
Rptr indicated that pt's device was programmed to a setting at which pt rec'd significant seizure control for almost six weeks. The physician increased the settings and the pt subsequently had almost 30 seizures in one day and fell down and broke jaw. The pt went to the hospital as a result of the injury. Physician reported that pt increased the device output current from 1. 0ma to 1. 25ma in 12/2001 in hopes of giving the pt even better seizure control. As a result of the increase in seizures and subsequent injury, the output current was reduced back to 1. 0ma in 1/2002 as recommended in device labeling. There was been no further indication of a continued increase in seizure frequency.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=372739

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dennis100
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« Reply #47 on: November 23, 2011, 04:10:26 PM »

Model Number 101
Event Date 03/01/2002
Event Type Injury Patient Outcome Hospitalization; Life Threatening Required Intervention
Event Description
Pt reported that they had an increase in seizure activity. It was reported that there have been some recent changes to their medication regimen and that pt has a low sodium level. The pt reported that pt feels like they have more of an awareness of their seizures. The pt reported that they had eeg monitoring to prove that pt is now having generalized instead of partial seizures. Further follow up revealed that the pt went in for telemetry monitoring because of an increase in seizures. The pt reported that when they would have seizures, use of the magnet would decrease the duration of the seizure. The pt reported they were an in-patient for 8 days during the testing. During the hospital stay, their sodium level decreased. The pt's trileptal prescription was changed to dilantin (600 mg po bid) in 2002. The pt reported that they used their magnet so often during the hospital stay that their voice was hoarse. Device programmed parameters were reduced in hopes of helping their voice recover. The pt was discharged from the hospital the following day. On the next day the pt experienced blurred vision, tachycardia, and trouble breathing. The pt was seen in the emergency room and was prescribed diastat. The er physician attributed the pt's symptoms to the sudden change to dilantin. Their dilantin dosage was reduced to 400mg on that day. It was later reported that the pt was hospitalized again 13 days later because they were experiencing a flurry of seizures. The physician did not make any further changes to the vns programmed parameters. Attempts to obtain additional info have been unsuccessful to date.

Manufacturer Narrative
The pt was released from the hosp in 2002. No parameters were changed during the stay. The physician told the pt their symptoms were psychological. The physician reported to the pt that the tachycardia and trouble breathing were related to stress and the position they sleep in. Chaning sleep positions resolved these symptoms and the pt did not have any further problems. The pt did not follow up with the physician after being discharged from the hosp. The pt followed up with another neurologist one week later and had their parameters adjusted. 2 days later they had an spisode of status and was hospitalized. During this hospitalization, the treating physician changed their medications (stopped dilantin and gabitril). The pt was released 6 days later.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=388523

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dennis100
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« Reply #48 on: November 23, 2011, 04:11:25 PM »

Model Number 100
Event Date 03/11/2002
Event Type Injury Patient Outcome Life Threatening; Hospitalization Required Intervention
Manufacturer Narrative
Method: device programming history was reviewed. Results: review of programming history showed no anomalies nor abnormalities. Conclusion: physician suspects that the loss of seizure control is related to medication reduction (taper of lomotrigine) and possible non-compliance with prescription by pt.

Event Description
Reporter indicated that the pt went into status in 2002 and went to the hosp where the pt was then taken to icu. Reporter also indicated that the pt had been doing "beautifully" prior to the event. Reporter indicated that the pt had been taking lamictol (500mg per day). The pt's neurologist decreased the dosage to 200mg per day. The pt started to have an increase in cluster seizures so the pt's neurologist increased the dosage back to 500mg per day. Further follow up revealed that the pt's seizure control has improved following an increase to previous levels of lamictol and an increase in programmed output current of the ncp system.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=388343

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dennis100
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« Reply #49 on: November 23, 2011, 04:12:17 PM »

Model Number 101
Event Date 01/01/2002
Event Type Injury Patient Outcome Life Threatening;
Event Description
Reporter indicated that the pt was experiencing drop seizures. The pt had previously not been having drop seizures since the vns implant. Further follow-up revealed that the pt's lamictal dosage was increased and the pt has not experienced any further drop seizures. Physician plans regular monitoring of anti-epileptic drug levels and seizure activity.

Manufacturer Narrative
H. 6. Code: device programming history was reviewed. H. 6. Code: review of device programming history did not reveal any anomalies. H. 6. Code: the physician indicated that the pt has not experienced any further drop attacks.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=388355

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« Reply #50 on: November 23, 2011, 04:13:12 PM »

Model Number 101
Event Date 02/28/2002
Event Type Injury Patient Outcome Life Threatening;
Event Description
Rptr indicated that the pt has had increased seizure activity since their last parameter change. In 2/2002, the device output current was increased to 1. 5ma. It was reported that on the next day the pt had an increase in grand mal seizures. This increase continued for several days. The pt is no longer having the increase in the grand mal seizures, but there has been an increase in the psychomotor seizures. Attempts to obtain add'l info have been unsuccessful to date.

Manufacturer Narrative
Further follow-up revealed that the pt's seizure activity has decreased from 200 seizures per month to 40 seizures per month since being implanted with the ncp system. The pt is reported to being doing very well.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=388395

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« Reply #51 on: November 23, 2011, 04:14:31 PM »

Model Number 100
 Event Date 03/01/2000
Event Type Injury Patient Outcome Life Threatening; Hospitalization Required Intervention
Manufacturer Narrative
Method: concomitant device (lead) was analyzed. Results: analysis of concomitant device (lead) concluded that only the lead connectors were returned. No discontinuities were identified on the lead portions returned, the condition of the lead is consistent with conditions that exist after the explant procedure.

Event Description
Reporter initially indicated that pt's device was explanted due to lack of efficacy. Further follow-up revealed that the pt had an increase in seizures when the device was activated two years ago. The device was turned off on 05/2000 due to the increase in seizures (5-25 per day). No pre-vns baseline number of seizures is documented in the current physician's file. The pt was on phenobarbitol at the time of implant. No medication changes were made during the first three months that the device was programmed on. After turning off the vns, the pt was prescribed keppra and then zonogram. The pt is currently stable on the medication. The pt requested that the device be explanted for cosmetic reasons.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=386268

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« Reply #52 on: November 23, 2011, 04:15:38 PM »

Model Number 100
Event Date 02/01/2002
Event Type Malfunction Patient Outcome Life Threatening;
Manufacturer Narrative
Attempts to have the generator returned for analysis have been unsuccessful to date.

Manufacturer Narrative
Review of mfg records did not reveal any anomalies or abnormalities that would have an adverse effect on device performance.

Event Description
Rptr indicated that the pt has had an increase in seizure activity and that the magnet no longer had any effect on the seizure activity. The pt was seen by neurologist who interrogated the device and found it to be set to 0ma output current. Inadvertent reset of the device output current to 0ma would cause a lack of vns therapy. The physician reprogrammed the device. Since the device was reprogrammed, the pt again has good seizure control. Investigation to date has been unable to determine whether the device reset was caused by user error during parameter adjustment, by normal end of service, or by device malfunction. Device parameters were adjusted at a previous office visit in 2001.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=387094

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dennis100
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« Reply #53 on: November 23, 2011, 04:16:38 PM »

Model Number 101
Event Date 02/13/2002
Event Type Injury Patient Outcome Hospitalization; Required Intervention
Manufacturer Narrative
Method: the manufacturing records were reviewed. Results: review of manufacturing records did not reveal any anomalies or abnormalities that would have an adverse effect on device performance. Patient fell; impact was directly to generator incision site.

Event Description
Reporter indicated that the patient fell on their left chest directly onto the surgical site about 6 months ago. After this incident, the generator migrated slowly towards the incision site. In the few days prior to explant, the incision site had opened and the generator was exposed. The patient was rushed to the emergency room and the generator was explanted. Re-implant is scheduled, pending insurance approval. It was reported that since explant, the patient has had no seizure control and that their behavior was "horrible".

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=385244
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dennis100
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« Reply #54 on: November 23, 2011, 04:17:32 PM »

Model Number 100
Event Date 01/01/2002
Event Type Injury Patient Outcome Life Threatening; Hospitalization Required Intervention
Event Description
Reporter indicated that pt started having very mild spells with just "gasping" (no convulsions). Previously the pt's arms and legs would extend out and pt would convulse when having a seizure. The pt had 3 very severe seizures in 2002. No injuries were reported. 3 days later, the pt had 4 very severe seizures and 5 mild seizures about 3-4 mins in between. The physician reduced the device output current from 3. 5 ma to 2. 5 ma 2 days later. 2 days later, the pt had 9 mild seizures. The physician programmed the pt's device to off the following day. That night, the pt started having very severe seizures. Pt was taken to the emergency room. The dr prescribed 5mg of diastat (a valim suppository), but the pt's family member were not able to get the prescription filled. 2 days later, the pt had 1 medium seizure that lasted about 2 minutes and 15 seconds. During six days, the pt didn't have any seizures at all. In 02/02 the pt had 4 severe seizures which continued to the following day. The next day, the pt went in for an appointment and the stimulation output current was turned up to 1. 0ma. The physician prescribed 15mg of diastat. The pt had 16 mild seizures on this day. The following, the pt took 15mg of diastat and didn't have any seizures following this. The next day, the device was set to 30 sec on, 5 mins off. The pt had small seizures every 5 mins. When the horsehsoe magnet was used it slowed the frequency of the seizures to 15 mins - 45 mins apart (most were 25-35 mins in between). The following day, the block magnet was used. The pt had many small seizures throughout the night at 5 min intervals that the block magnet did not stop. No magnet was used at all. The pt was given 15mg of diastat and pt continued having seizures. The block magnet was used again and the pt was still having seizures. Following all of this, the pt's family member took pt to see the physician again (date unknown). The physician ran a lead test which resulted in ok lead impedance, indicating proper device function. The pt's family member is in the process of changing physician's. Attempts to obtain add'l info have been unsuccessful to date.

Manufacturer Narrative
Further follow-up revealed that the patient's device was turned off on 02/12/2002. The patient was last seen by the physician on 03/19/2002 and was much improved. The patient's device has not been returned back on.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=385294

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dennis100
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« Reply #55 on: November 23, 2011, 04:20:48 PM »

Model Number 300-20
Event Date 01/01/2002
Event Type Injury Patient Outcome Life Threatening;
Manufacturer Narrative
Further follow-up revealed that the pt was seen on 3/13/2002 by the physician. It was reported that the pt's device was reprogrammed and that the pt defintely felt stimulation. Physician indicated that the pt was doing fine. Method: x-rays were reviewed. Results: review of x-rays showed no anomalies or abnormalities.

Manufacturer Narrative
Method: device manufacturing records were reviewed. Results: review of manufacturing records did not reveal any anomalies or abnormalities that would have an adverse effect on device performance.

Event Description
Reporter indicated that the patient could no longer feel stimulation and that their seizures have increased. Further follow up revealed that the patient's device was intially programmed to on at 0. 75ma output current 11/2001 and the patient was doing extremely well. The patient later reported that could no longer feel stimulation. In 2002, the physician increased the output current to 1. 00 and then to 1. 25ma, but the patient still couldn't feel stimulation. A lead test run on the device while programmed to 1. 25ma output current resulted in ok lead impedance reading, indicating proper device function. At next office visit on 02/02, the patient continued to report that they could not feel stimulation. Device output current was increased to 3. 5ma at this office and the patient still did not feel stimulation. No lead test was performed at this visit. Lead malfunciton is suspected. Attempts to obtain additional information have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=380959

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dennis100
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« Reply #56 on: November 23, 2011, 04:21:43 PM »

Model Number 300-20
Event Date 01/01/2002
Event Type Injury Patient Outcome Life Threatening;
Manufacturer Narrative
Further follow-up revealed that the pt was seen on 3/13/2002 by the physician. It was reported that the pt's device was reprogrammed and that the pt defintely felt stimulation. Physician indicated that the pt was doing fine. Method: x-rays were reviewed. Results: review of x-rays showed no anomalies or abnormalities.

Manufacturer Narrative
Method: device manufacturing records were reviewed. Results: review of manufacturing records did not reveal any anomalies or abnormalities that would have an adverse effect on device performance.

Event Description
Reporter indicated that the patient could no longer feel stimulation and that their seizures have increased. Further follow up revealed that the patient's device was intially programmed to on at 0. 75ma output current 11/2001 and the patient was doing extremely well. The patient later reported that could no longer feel stimulation. In 2002, the physician increased the output current to 1. 00 and then to 1. 25ma, but the patient still couldn't feel stimulation. A lead test run on the device while programmed to 1. 25ma output current resulted in ok lead impedance reading, indicating proper device function. At next office visit on 02/02, the patient continued to report that they could not feel stimulation. Device output current was increased to 3. 5ma at this office and the patient still did not feel stimulation. No lead test was performed at this visit. Lead malfunciton is suspected. Attempts to obtain additional information have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=380959

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dennis100
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« Reply #57 on: November 23, 2011, 04:23:07 PM »

Model Number 101
Event Date 12/01/2001
Event Type Injury Patient Outcome Life Threatening;
Manufacturer Narrative
Further follow-up revealed that the physician does not believe the device is malfunctioning and that the pt's device was explanted at the request of the pt.

Manufacturer Narrative
Review of manufacturing records did not reveal any anomalies or abnormalities that would have an adverse effect on device performance. No anomalies or deficiencies were noted in the programming history. The device has acceptable results on all lead tests and magnet mode tests on 12/17/2001. No anomallies were noted in the magnet mode database. The following dates are estimated. Only the month/year is known: b. 3, date of event.

Event Description
Reporter indicated that the patient claims the vns is not working when patient is at the bowling alley around the electronic scorer, or when patient is at a bar or club. Lead test resulted in normal lead impedance, indicating that the device was functioning properly. The patient continued to report the speakers at the bowling alley "turn patient's device off". The patient does not believe that the device comes back on when patient leaves the bowling alley or bar. Patient reportedly has experienced an increase in both partial-complex and tonic-clonic seizures as a result of the device being inadvertently "turned off" as previously reported at the bowling alley and bar. It was reported that the patient was having a decrease in seizures prior to the episodes at the bowling alley and bar. At office visit in 2002, the patient swiped the device with a cybermagent and did not feel the device stimulate. The patient then tried swiping the device with a horseshoe magnet and patient finally felt it stimulate. A cybermagent was used again and this time patient felt the stimulation. The patient believes that swiping the device with the horseshoe magnet finally turned the device back on from when it "turned off" at the bar. The physician instructed the patient to use the horseshoe magnet until further notice. The patient is very thin and the generator is implanted subcutaneously as recommended in device labeling. The patient later reported that patient continues to experience an increase in seizures and that patient does not believe that the device is working with the horseshoe magnet. The patient reportedly does not feel magnet mode stimulation when patient swipes the device with the horseshoe magnet. Further follow up revealed that pre-vns, the patient experienced 12-13 seizures a month. Since implant, the patient only has 2 seizures per month, but lately patient has had an increase in tonic-clonic seizures. The increase occurred at the same time that the physician was reducing the patient's phenobarbital medication. The physician stopped the reduction of the medication, but the patient has not yet had any improvement. The physcian plans to check the patient's blood levels at patient's next appointment.

Manufacturer Narrative
Deleted conclusion.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=381819

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dennis100
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« Reply #58 on: November 23, 2011, 04:24:38 PM »

Model Number 300-20
Event Date 03/01/2002
Event Type Malfunction Patient Outcome Life Threatening; Hospitalization Required Intervention
Manufacturer Narrative
H. 6 method: device manufacturing records were reviewed. Device programming history was reviewed. H6 results: review of manufacturing records confirmed sterilization of devices. No anomalies nor abnormalities were noted that would have an adverse effect on device performance. Review of device programming history confirmed high lead impedance condition as reported. The eri (elective replacement indicator) flag was no, indicating that the pulse generator has not reached end of service. The pt reportedly irritated/scratch incision site. H6 conclusion: the infection is reportedly resolved.

Event Description
Reporter indicated that pt had undergone exploratory surgery on 05/2002 due to suspected device malfunction. Further follow-up revealed that the pt was seen by physician on an urgent basis on 03/2002 due to an increase in seizure frequency. Device diagnostic testing at office visit on 03/2002 resulted in high lead impedance reading indicating possible device malfunction. Prior device diagnositc testing at office visit on 12/2001 was within normal limits. The pt reportedly had 1 complex partial seizure and 30 seizure-free days in december 2001. In january 2002, the pt had 5 complex partial seizures and 28 seizure-free days. In february 2002, the pt had 18 complex partial seizures and 24 seizure-free days. In march 2002, the pt had an increase in seizures with total of 144 and only 5 seizure-free days. X-rays prior to surgery did not reveal any discontinuities in the ncp system. During the exploratory surgery, one lead connector was noted to be anterior to the generator, and the other was posterior. Both connectors were moved to the side of the generator. No other anomalies were noted during the exploratory surgery. The lead/generator connection appeared to be normal and no breaks in the lead were noted. Intra-operative device diagnostic testing was within normal limits. Device diagnostic testing the day after the exploratory surgery and at office visits since then continue to result in high lead impedance readings it is not known whether device replacement surgery is planned at this time. Additionally, the pt reportedly developed an infection at the generator pocket area following the exploratory surgery. The pt was in the hosp for iv antibiotic treatment and i&d. The infection has reportedly resolved.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=409132


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dennis100
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« Reply #59 on: November 23, 2011, 04:25:55 PM »

Model Number 101
Event Date 04/10/2002
Event Type Malfunction Patient Outcome Life Threatening; Hospitalization Required Intervention
Event Description
Reporter indicated that the pt was experiencing erratic stimulation, indicating possible device malfunction. The pt reportedly experienced good seizure control until 2002. When an increase in seizure activity reportedly occurred. The pt was seen by physician the next day. Device diagnostic testing at this office visit was within normal limits. The device output current was increased from 1. 75ma to 2. 0ma at this visit. The pt's seizure activity seemed to be under control following the parameter adjustment. The pt was seen by physician again in 05/2002 at which time device diagnostic testing again was within normal limits. The era (elective replacement indicator) was no, indicating that the generator was not at end of service. In 05/2002, the pt was taken to the emergency room after injuring self from a fall during a seizure. The pt was last seen by physician in 06/2002. Device diagnostic testing at this office visit was again within normal limits. The pt is shceduled for device replacement surgery in one month due to the pt's increase in seizure activity.

Manufacturer Narrative
H. 6. Device manufacturing records were reviewed. Device programming history was reviewed. Review of manufacturing records did not reveal any anomalies that would have an adverse effect on device performance. Review of device programming history did not reveal any anomalies. Device diagnostic testing was within normal limits.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=408100

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