VNS Message Board

VNS DISCUSSIONS => Legislative Activism In Regards to VNS => Topic started by: dennis100 on November 23, 2011, 03:19:03 PM



Title: Increase/Worsening of Seizures
Post by: dennis100 on November 23, 2011, 03:19:03 PM
Event Date 01/01/2001
Event Type Injury
Patient Outcome Life Threatening;
Manufacturer Narrative
Attempts to obtain additional information were unsuccessful.

Event Description
Reporter indicated that patient has experienced an increase in seizures since vns implant.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=341538


Title: Re: Increase in seizures
Post by: dennis100 on November 23, 2011, 03:19:38 PM
Event Date 06/07/2001
Event Type Injury Patient Outcome Life Threatening;
Manufacturer Narrative
Attempts to obtain additional information have been unsuccessful.

Event Description
Reporter indicated that patient has experienced an increase in seizures and that the magnet does not appear to be working but that the patient does appear to bounce back from seizures better with the use of the magnet.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=342112


Title: Re: Increase in seizures
Post by: dennis100 on November 23, 2011, 03:20:05 PM
Model Number 101
Event Date 06/02/2001
Event Type Injury Patient Outcome Life Threatening; Required Intervention
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. Pt's parameters were reduced. Follow up visit scheduled for july.

Event Description
Reporter indicated that pt suffered a status episode approximately 3 months post-implant. The pt has not experienced such an event for approximately 15 years. It was also reported that the pt has had a significant increase in seizures for the past few weeks.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=340280



Title: Re: Increase in seizures
Post by: dennis100 on November 23, 2011, 03:20:40 PM
Model Number 101
Event Date 01/01/2001
Event Type Injury Patient Outcome Life Threatening;
Event Description
Reporter indicated that patient's device was turned off due to an increase in seizures. It was reported that the patient "did not feel right".

Manufacturer Narrative
Reporter indicated that the pt was set to off on 8/21/2001. Physician claims that vns therapy did work for the pt and that the device will remain off. The physician is treating the pt with anti-epileptic medications alone. Method: device mfg records and device programming history were reviewed. Results: review of mfg records did not reveal any anomalies or deficiencies that would have an adverse effect on device performance. No anomalies nor abnormalities were seen when reviewing the complete programming history. Diagnostic data demonstrated the device was functioning as intended. Conclusion: the physician stated that the device remains off. The pt is being treated with medications alone.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=356540



Title: Re: Increase in seizures
Post by: dennis100 on November 23, 2011, 03:21:10 PM
Model Number 101
Event Date 02/01/2001
Event Type Injury Patient Outcome Other;
Event Description
Reporter inicated that pt seems to have more seizures with each parameter change.

Manufacturer Narrative
The physician called and stated the pt's drug regimen has been changed and that the pt is seizure frequency is currently back to baseline. The physician said that they will give it time, try different parameters and "see what happens".

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=327116


Title: Re: Increase in seizures
Post by: dennis100 on November 23, 2011, 03:22:14 PM
Model Number 100
Event Date 01/06/1999
Event Type Injury Patient Outcome Hospitalization; Required Intervention
Manufacturer Narrative
Follow up with physician on 02/4/99 indicates that pt did very well, experiencing no seizures, for approximately two weeks after stimulation was reinitiated on 1/8/99. The pt has begun having daily seizures again; however, they are less severe than prior to ncp imlant.

Event Description
A 17 yr old female pt was implanted with ncp on 12/28/98. Pt returned to the office for initiation of stimulation on 1/5/99. Left office programmed to 0. 5 ma, 30 hz, 500 msec, 30 sec. On, 5 min. Off. Pt had multiple petit mal seizures that evening and recovered. At about 7:00 am on 1/6/99, pt had a generalized convulsion. Pt had another generalized convulsion 1 hr later. Pt was instructed to come to dr's office where a third generalized convulsion was witnessed. Dr. Reported a total of 4 generalized convulsions in about a 4 hr period. Prior to this incident, the pt had not experienced a generalized convulsion in 8 mos. The generator was turned off and pt was admitted to hosp where she was stabilized. On 1/8/99, stimulation was restarted at 0. 24 ma, 20 hz, 500 msec, 30 sec. On, 5 min off. Pt tolerated that setting well; therefore remained at that setting. Pt was released on 1/9/99. Clinic note dated 1/15/99 indicated that pt is doing well with no repeated occurrence of generalized convulsions.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=208744


Title: Re: Increase in seizures
Post by: dennis100 on November 23, 2011, 03:23:38 PM
Model Number 300-20
Event Date 02/06/2001
Event Type Malfunction
Patient Outcome Life Threatening; Hospitalization Required Intervention
Manufacturer Narrative
Results: no anomalies or abnormalities were noted in analysis of concomitant device. Analysis of lead revealed a break in the lead tubing and negative lead coil.

Event Description
Reporter indicated that device was explanted due to lack of efficacy. Further investigation revealed that pt had a slight improvement in seizures, then had no change, then an increase in seizures over time. Product analysis revealed a break in the lead tubing and negative lead coil.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=329922


Title: Re: Increase in seizures
Post by: dennis100 on November 23, 2011, 03:25:14 PM
Model Number 300-20
Event Date 01/22/2001
Event Type Injury Patient Outcome Life Threatening;
 Event Description
The reporter indicated that for 6 months post-implant the patient responded positively to the vns (vagal nerve stimulation). The patient then experienced an increase in their seizures. The reporter also stated that the patient presented with a protrusion at the neck.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=330257



Title: Re: Increase in seizures
Post by: dennis100 on November 23, 2011, 03:25:49 PM
Model Number 101
Event Date 02/07/2001
Event Type Malfunction
Manufacturer Narrative
Method: device mfg records were reviewed. Results: review of device mfg records did not reveal any anomalies nor abnormalities that would have an adverse effect on device performance. Further f/u concluded that the device was mistakenly set to 0. Ma. Programming history showed that device was set to. 0ma on 12/11/00. In feb, the pt had an "unusual number of seizures. " on 2/9/01, the physician reprogrammed the device to 1. 5ma.

Manufacturer Narrative
Customer did not provide mfr with information requested to perform investigation.

Event Description
After pt fell while skiing, device did not seem to be working properly.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=330716



Title: Re: Increase in seizures
Post by: dennis100 on November 23, 2011, 03:26:30 PM
Model Number 300-20
Event Date 10/30/2000
Event Type Malfunction
Event Description
Patient's device diagnostic tests indicated high lead impedance. Patient's seizure rate has increased and seizures are now accompanied by syncope and breath holding.

Manufacturer Narrative
Further follow-up revealed that the pt's lead and generator was explanted. During the explant procedure a fracture was observed in the lead. Method: device mfg records were reviewed. Results: review of mfg records did not reveal any anomalies or abnormalities that would effect device pefformance.

Manufacturer Narrative
Method: x-rays and device programming history reviewed. Results: x-rays did not reveal any anomalies or abnormalities. Review of program parameters confirmed high impedance reading.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=330795

Model Number 300-20
; Other
Manufacturer Narrative
Concomitant device was analyzed. Reviewed programming history. The concomitant device met electrical test specifications. No visual anomalies were detected or identified that have an adverse effect on device performance. No anomalies nor abnormalities were found after reviewing the programming history. The condition of the lead is consistent with conditions that exist after the explant procedure. No anomalies that could have an adverse effect on the device performance were identified. The reason for analysis was not duplicated.




Title: Re: Increase in seizures
Post by: dennis100 on November 23, 2011, 03:31:05 PM
ManufactureEvent Date 12/08/2000
Event Type Malfunction
Manufacturer Narrative
Results: lead assembly was cut during the explant; it was returned in two pieces.

Event Description
Reporter indicated that the patient's device showed high lead impedance and the seizures have increased.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=330803


Title: Re: Increase in seizures
Post by: dennis100 on November 23, 2011, 03:31:38 PM
Model Number 300-20
Event Date 03/01/2001
Event Type Malfunction
Patient Outcome Hospitalizationr Narrative
The following dates are estimated. Only the month/year is known: b. 3, date of event.

Event Description
Pt began to experienced an increase in seizures. Suspected end of service of generator. Lead break noted during generator replacement surgery.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=328925


Title: Re: Increase in seizures
Post by: dennis100 on November 23, 2011, 03:32:15 PM
Model Number 101
Event Date 02/23/2001
Event Type Injury Patient Outcome Required Intervention;
Event Description
Rptr indicated that pt complained of being unable to sleep due to the vns sensation. The pt complained that the sensation was positional and that in certain positions the pt would feel pain in throat, temple, and forearm "like being hit with a rock". Pt states that the pt is unable to sleep if lies on right side due to the pain in throat and shortness of breath. Pt reported to be experiencing dysesthesias in left hand and pain around the site of surgery which is constant but increases with stimulation when lies on right side. This pain radiates to ear and at times to left temporal region. Pt has also complained of increase in seizures since activation. Device programmed to off 6 days later.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=328089



Title: Re: Increase in seizures
Post by: dennis100 on November 23, 2011, 03:32:59 PM
Model Number 101
Event Date 10/01/2000
Event Type Injury Patient Outcome Life Threatening;
Event Description
Reporter indicated that patient seizures have increased in number and in severity since vns implant.

Manufacturer Narrative
The pt's device was programmed off on 5/3/01. At the pt's request, they were explanted. The device was not returned to cyberonics. The pt continues to have the same amount of seizures as they had when they were implanted. The physician stated that no reimplant is scheduled.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=326150


Title: Re: Increase in seizures
Post by: dennis100 on November 23, 2011, 03:33:41 PM
Model Number 100
Event Date 04/01/2001
Event Type Malfunction
Manufacturer Narrative
Results: no anomalies were identified via external visual inspection. The pulse generator met electrical test specifications. Initial interrogation of the pulse generator performed upon receipt identified that the serial number of the device was corrupted. The pulse generator was re-interrogated several times without corrupting the serial number. The reason for the corrupted serial number was not ascertained. Follow up with site revealed that the pt has had incredible seizure control with the vns implant. The device was replaced because it was thought to be nearing end of service and because the pt began to experience a slight increase in seizures. Pt reported to be having excellent seizure control with replacement device.

Event Description
Explanted device returned with no explantation. Further investigation could not rule out premature end of service.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=340340


Title: Re: Increase in seizures
Post by: dennis100 on November 23, 2011, 03:34:32 PM
Model Number 300-20
Event Date 06/20/2001
Event Type Malfunction
Manufacturer Narrative
On 08/01, the nuerologist's office staff stated that the surgeon and neurologist decided to turn off the vns indefinitely. There was an increase made to the pt's medications to help control the pt's seizures. They are not going to do any surgery at this time.

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

Event Description
Reporter indicated high lead impedance. Additional, patient does not feel magnet stimulation and is experiencing increased seizures. Increasing the output current did not have an effect on stimulation perception. No prior lead test results have been recorded.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=342336



Title: Re: Increase in seizures
Post by: dennis100 on November 23, 2011, 03:35:09 PM
Model Number 101
Event Date 06/01/2001
Event Type Injury Patient Outcome Life Threatening;
Manufacturer Narrative
Further investigation revealed that the pt is deeply retarded, lives in a group home, and pt's seizures are not easily detectable. The physician indicated that it seems like pt had an increase in seizures following the implant. The pt is on four different epilepsy drugs and pt's primary neurologist just added a fifth. The device was turned back on during the first week of july and the pt is reported to be doing better.

Event Description
Rptr indicated that pt has been in and out of the emergency room and was currently admitted to the hospital. The pt has had a flurry of seizures. The magnet was taped over the device to temporarily turn the device off. This helped initially, but even with the magnet the pt is having breakthrough seizures.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=343879



Title: Re: Increase in seizures
Post by: dennis100 on November 23, 2011, 03:35:45 PM
Model Number 300-20
Event Date 06/01/2001
Event Type Malfunction
Manufacturer Narrative
Scanning electron microscopy was performed. A continuity check using a multimeter was performed. Scanning electron microscopy identified several partial breaks in the coil wires at the are where the lead coils were twisted and revealed that the lead break was caused by torsion of the lead as evidenced by the surface appearance of the fractured woil wires. No pitting of metal was observed. Continuity check using a multimeter showed no other discontinuities on the portion of the lead asssembly returned.

Event Description
Initial report indicated that patient was experiencing an increase in seizures and could no longer feel the normal and magnet mode stimulation. Both the lead test and normal mode test were normal with a dc-dc code of zero. The patient and physician are unfamiliar with previous programming parameters since the patient was followed by another physician. The site was concerned that the device may be nearing end of service. During surgery to replace the generator, a lead break was noticed. Both devices were explanted.

Manufacturer Narrative
Method: known device programming parameters were reviewed. Concomitant product was returned and analyzed. Results: review of known device programming parameters was inconclusive in determining whether or not the device had reached normal end of service. Analysis of returned generator 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=342388



Title: Re: Increase in seizures
Post by: dennis100 on November 23, 2011, 03:36:34 PM
Model Number 100
Event Date 06/01/2000
Event Type Injury Patient Outcome Life Threatening;
Manufacturer Narrative
Method: physician performed a diagnostic test. Results: diagnostics were within normal limits. Further follow up revealed that the pt went into status on 9/12/2001 and was taken to the hosp. On 9/13/2001, the device was programmed to 2ma. A diagnostic test was done on 12/11/2001 and the results indicated that the device was operating properly with a dc-dc code of 3. The pt's seizure control has not improved since the assault.

Event Description
Reporter indicated that patient was assaulted. Since the assault, the patient's seizures have increased.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=342212



Title: Re: Increase in seizures
Post by: dennis100 on November 23, 2011, 03:38:37 PM
Model Number 101
Event Date 05/01/2001
Event Type Injury Patient Outcome Required Intervention;
Event Description
Reporter indicated that patient began to have trouble walking approximately 2 weeks post-activation. In 2001, family member reported that the patient was not following commands and was losing cognitive information that the patient once knew. Device was programmed to off.

Manufacturer Narrative
In 2001, it was reported that the pt has also been weaned off of two medications. He is currently on one medication. He is walking, toilet training and overall doing much better. The device continues to be programmed off and there are no plans to activate the device in the future.

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. One month after programming device to off, it was reported that the patient has cognitively improved with less frequency of seizures and shorter durations. Keppra 250mg po bid was started with the hope of discontinuing the klonopin. Since implant, the patient has been on lamictal, klonopin, and rectal diastat. No changes in these meds have been made since implant. The device is still programmed to off.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=342214



Title: Re: Increase in seizures
Post by: dennis100 on November 23, 2011, 03:39:32 PM
Model Number 100
Event Date 06/25/2001
Event Type Malfunction
Patient Outcome Hospitalization;
Manufacturer Narrative
Method: mfg records were reviewed. Result: review of mfg records did not reveal any abnormalities or anomalies that would have an adverse effect on device performance.

Manufacturer Narrative
Explanted lead was discarded. Awaiting return of explanted generator for analysis.

Event Description
Reporter indicated that patient had a mri done in 2001. Instead of programming the device to off, the mri techs just swiped the magnet over the generator and thought that would turn off the device. Following the mri, the patient reports not feeling the stimulation, no voice changes, and an increase in seizures. Magnet activations in the following month have not shown up on the magnet history. System was replaced later in 2001.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=349144



Title: Re: Increase in seizures
Post by: dennis100 on November 23, 2011, 03:40:45 PM
Model Number 101
Event Date 12/01/2000
Event Type Injury Patient Outcome Hospitalization;
Manufacturer Narrative
Method: sterilization records reviewed. Conclusions: sterilization parameters were within specification. Further investigation revealed that in june 2001 the pt had an increase in seizures and was lethargic again. Pt was admitted to the hospital and all cultures were negative. No antibiotics were prescribed. Pt recovered on rest alone. Physician indicated that the problems that the pt has had over the past several months were not related to the ncp system. The following dates are estimated. Only the month/year is known: b. 3, date of event.

Event Description
Reporter indicated that pt became lethargic, would not drink anything, and had a loss of alertness approx 2 months post-implant. Antibiotics were prescribed. Five months after implantation, the same signs and symptoms recurred and blood culture was positive for staph. Antibiotics were again prescribed. Two months later, pt began to experience a decrease in seizure control. Tegretol and depakote were discontinued and sonogram was prescribed. Pt began to be lethargic and blood test revealed that the sonogram caused a decrease in pt's white blood count. Sonogram was discontinued and topomax was prescribed. White blood count was still noted as low, so topomax was discontinued and original medications were resumed (tegretol and depakote).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=346456



Title: Re: Increase in seizures
Post by: dennis100 on November 23, 2011, 03:41:59 PM
Model Number 300-20
Event Date 08/22/2001
Event Type Malfunction
Manufacturer Narrative
Lead replacement was performed. Pt's seizure frequency has decreased with new lead.

Event Description
Reporter indicated that over past several months the patient has had a progressive increase in seizures. The pt was having 3 seizures a month, but in the past 2 months the pt has had 8. A lead test was run in 2001 with a high impedance result (dc-dc code 7 and limit). It is not believed that the patient has suffered any falls or trauma recently. Physician ordered an x-ray because he believed that the lead could be mispositioned due to the patient's growth. Lead replacement surgery is being considered.

Manufacturer Narrative
Method: mfg records were reviewed. Results of the mfg records did not reveal any anomalies or abnormalities that would have an adverse effect on device performance. A certified letter requesting the lead be returned for analysis was sent, however the lead has not been rec'd.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=353515



Title: Re: Increase in seizures
Post by: dennis100 on November 23, 2011, 03:42:57 PM
Model Number 100
Event Date 06/01/2001
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 generator was replaced due to increased in seizures over past four months. Pt was reported to have received a 75% reduction in seizures prior to the increase in seizures. Dc-dc code prior to generator replacement was 4. The eri (elective replacement indicator) flag was "no". After replacing only the generator, the dc-dc code was 2.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=359658



Title: Re: Increase in seizures
Post by: dennis100 on November 23, 2011, 03:47:38 PM
Model Number 300-20
Event Date 09/24/2001
Event Type Malfunction
Manufacturer Narrative
Further follow-up concluded that the lead was replaced on 10/25/01. To date, the cause of the high lead impedance is unknown. Two attempts to obtain the lead for analysis have been unsuccessful. A hospital representative believes the lead was discarded following the explant.

Manufacturer Narrative
Method: device programming history reviewed. Results: review of device programming history confirmed that a lead test was run in 2001 that resulted in high lead impedance (dc-dc code 7 and limit). The last lead test was run on 08/20/01 and reported acceptable values (dc-dc code 2, ok, ok).

Event Description
Reporter indicated that high lead impedance result was obtained during lead test at office visit i(dc-dc code 7 and limit). Physician reported that he believes that the patient is receiving stimulation because of the pt's voice change during events. Further investigation revealed that by 2001 the patient was no longer able to perceive stimulation and had gone from complete seizure control to having 10-12 seizures per day.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=358953



Title: Re: Increase in seizures
Post by: dennis100 on November 23, 2011, 03:48:26 PM
Model Number 101
Event Date 08/14/2001
Event Type Injury Patient Outcome Life Threatening;
Event Description
Rptr indicated that pt's seizure pattern has changed since vns implant. Prior to the vns, the pt was typically having one seizure per day. Since the vns implant, the pt will go for days without a seizure, but then will have a cluster (as many as 8 or 9 day). The seizures were reported to also be much more intense than before the vns implant. Accordingly to physicians, the pt is not a candidate for surgery and there are no more medications to try. The pt is currently on trileptol. Further investigation revealed that device was programmed to on approximately two weeks after implant at 0. 25ma. The pt did not experience any seizures following the device activation. Twelve days prior to event, the output current was adjusted to 0. 5ma. On the day of the event the pt experienced 6 seizures. Two days later the output current was again increased to 0. 75ma and again on about two weeks later to 1. 0ma. The pt's mother reported that the pt was doing okay during this period. Then four days after this, the pt experienced 9 seizures. Again nine days later, the pt experienced 8 seizures. Finally about a week after this, the output current was increased to 1. 25ma. At this office visit, the physician also suggested the child be placed on an add'l anti-epileptic drug (zonegram) and wait two months before adjusting the parameters any further.

Manufacturer Narrative
On 12/4/01 the physician saw the pt in the office. It was noted that he is having 15-20 seizures a month. He is not responding to trileptal. His device is programmed to 1. 25ma. The magnet stimulation controls the seizures when he is having a cluster of seizures. The pt was started on keppra with plans to titrate up in dosage depending on clinical response. The physician also decreased the pulse width on the vagal nerve stimulator. The physician wanted to see the pt back in six weeks or sooner if there were problems. As of 1/10/02, the pt has not scheduled an appointment with the physician. Method: mfg records were reviewed. Results: review of mfg records did not reveal any abnormalities or anomalies that would have an adverse effect on device performance.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=357409



Title: Re: Increase in seizures
Post by: dennis100 on November 23, 2011, 03:49:10 PM
Model Number 100
Event Date 04/01/2000
Event Type Injury Patient Outcome Required Intervention;
Manufacturer Narrative
The following dates are estimated. Only the month/year is known: b. 3, date of event.

Event Description
Initial report indicated that approx one month after vns implant, pt began to experience drop seizures. It was reported that the pt never showed any seizure improvement from the vns, but suffered from an increase in seizures and now drop attacks. The pt never suffered from drop attackes pre-vns. Further investigation (01/2001) revealed that a decrease in programmed parameters resolved the pt's increase in seizures and drop attacks. It was again reported on 09/2001 that the pt has been having drop attacks and that the device was programmed to off on 07/2001. Physician indicated that he believed that the vns seemed to cause the drop attacks. The drop attacks seemed to be resolved after programming the deivce to off on 07/2001, but then additional drop attacks occurred in 17 days later, and in 09/2001, and 8 days later even with the device programmed to off. No further action is planned. The physician does not plan to program the device back on. The pt has been started on zonogram and gabitril has been reduced.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=357596



Title: Re: Increase in seizures
Post by: dennis100 on November 23, 2011, 03:49:57 PM
Model Number 300-30
Event Date 07/01/2001
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 a dc-dc code of 7 and limit was obtained during a lead test in 09/2001. Additionally, the pt had no reaction following a magnet swipe on the same day. The pt was last seen in 7 weeks prior to lead test and did illicit a response following a swipe of the magnet at that visit, however the site had never run a lead test before. The pt has recently been put into a group home. It was preported that since the july office visit, the pt has had an increase in seizures (4-5 per month as opposed to 1-2 per month). Physician plans to replace the lead.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=357935



Title: Re: Increase in seizures
Post by: dennis100 on November 23, 2011, 03:50:38 PM
Model Number 100
Event Date 09/08/2001
Event Type Injury Patient Outcome Life Threatening; Hospitalization

Event Description
Reporter indicated that patient was admitted to hospital for increased seizures in 2001. Patient was seen for a follow up visit 10 days later after being released from the hospital. At the follow up visit, interrogation of the generator resulted in "s/n corrupt" error message. Patient was reprogrammed to minimal settings. The last time the patient was seen was 7/2001. The vns was not interrogated at that visit, but the physician's notes indicated that the patient was doing well at that time. In 8/2000, the output current was increased to 3. 25ma and physician noted that the patient was on rapid cycle parameters. Further investigation revealed that at 09/2001 office visit, "s/n" corrupt" error message was again obtained upon interrogation of the generator. Physician re-entered the s/n and ran a lead test. The dc-dc code was 3 and the eri (elective replacement indicator) flag was "yes". Physician plans to replace the generator.

Manufacturer Narrative
Further follow-up revealed that only the pulse generator was replaced. Physician indicated that the pt is doing well with the new pulse generator.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=357153



Title: Re: Increase in seizures
Post by: dennis100 on November 23, 2011, 03:51:36 PM
Model Number 101
Event Date 07/10/2001
Event Type Injury Patient Outcome Required Intervention;
Manufacturer Narrative
Available programming history shows that the pt was turned on in 2001 to the following settings: 0. 25 ma-output current, 250 microseconds-pulse width, 30 hz-frequency, 30 seconds-on time, 5 minutes-off time, 0. 5 ma-magnet mode output current, 250 microseconds-pulse width, 60 seconds-magnet mode on time. At the 3 months visit dated 5/2001 the pt was set to 1. 25 ma, 500 microsec. , 30 hz, 30 sec, 5 min, 1. 5 ma, 500 microsec, 60 sec (respectively).

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 was programmed to off in 2001 because of more frequent and severe seizures. Further investigation revealed that the patient has had a decrease in seizures since programming the device to off.

Manufacturer Narrative
The device programming history was reviewed. No anomalies or abnormalities were sween when reviewing programming history. Further follow-up revealed that at the first few office visits following vns implant, the vns seemed to be helfpul in decreasing the frequency and severity of the patient's seizures. At the fourth visit the patient's family member indicated that the patient was experiencing more seizures since vns implant. The patient experienced a 45 minute seizure in 2001 that resulted in an emergency room visit. It was reported that the following month, the patient was more alert but continued to have seizures. At this point the patient was having approximately 36 grand mal seizures per month and greater than 100 complex partial seizures per month. 2 month later, caregiver indicated that seizures again seemed to have worsened. It was reported that at this time, the patient was having a cluster of grand mal seizures every three to four days during which time they would have nine grand mal seizures in a period of 30-45 minutes. It was reported that these seizures seemed "harder" and "scarier" than past seizures. As a result of the increase in seizure frequency and severity, the vns was programmed to off. It was reported that the patient was doing well one month later. 2 month later, physician's notes indicate that the patient had a decrease in seizures since programming the vns to off. The patient went 19 days without generalized tonic clonic seizures, but was still having cluster seizures. At this office visit, ambien was prescribed for insomnia. Physician's notes from office visit 2 month later indicate that the patient continues to have episodic seizures and that their insomnia was unberable. The patient's family member believes that the patient's insomnia is worse since the vns implant. The patient continues to have grand mal seizures approxi ately every seven days.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=355983


Title: Re: Increase in seizures
Post by: dennis100 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


Title: Re: Increase in seizures
Post by: dennis100 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



Title: Re: Increase in seizures
Post by: dennis100 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


Title: Re: Increase in seizures
Post by: dennis100 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


Title: Re: Increase in seizures
Post by: dennis100 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



Title: Re: Increase in seizures
Post by: dennis100 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



Title: Re: Increase in seizures
Post by: dennis100 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



Title: Re: Increase in seizures
Post by: dennis100 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



Title: Re: Increase in seizures
Post by: dennis100 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



Title: Re: Increase in seizures
Post by: dennis100 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


Title: Re: Increase in seizures
Post by: dennis100 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



Title: Re: Increase in seizures
Post by: dennis100 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



Title: Re: Increase in seizures
Post by: dennis100 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



Title: Re: Increase in seizures
Post by: dennis100 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



Title: Re: Increase in seizures
Post by: dennis100 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



Title: Re: Increase in seizures
Post by: dennis100 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



Title: Re: Increase in seizures
Post by: dennis100 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



Title: Re: Increase in seizures
Post by: dennis100 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



Title: Re: Increase in seizures
Post by: dennis100 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



Title: Re: Increase in seizures
Post by: dennis100 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



Title: Re: Increase in seizures
Post by: dennis100 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



Title: Re: Increase in seizures
Post by: dennis100 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



Title: Re: Increase in seizures
Post by: dennis100 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



Title: Re: Increase in seizures
Post by: dennis100 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


Title: Re: Increase in seizures
Post by: dennis100 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



Title: Re: Increase in seizures
Post by: dennis100 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



Title: Re: Increase in seizures
Post by: dennis100 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



Title: Re: Increase in seizures
Post by: dennis100 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



Title: Re: Increase in seizures
Post by: dennis100 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




Title: Re: Increase in seizures
Post by: dennis100 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



Title: Re: Increase in seizures
Post by: dennis100 on November 23, 2011, 04:26:44 PM
Model Number 101
Event Date 05/01/2002
Event Type Injury Patient Outcome Life Threatening; Required Intervention
Event Description
Reporter indicated that patient has experienced a decrease in blood pressure since vns implant. Stimulation was initiated in 05/2002. The patient's baseline systolic blood pressure was 120 and is now 90-100. The patient's heart rate is unchanged and runs 60-80 bpm. The pt is reportedly asymptomatic with this blood pressure. The pt has aslo experienced an increase in their seizure activity. Patient has had 2 generalized tonic-clonic seizures in the past three weeks, which is reportedly an increase in frequency from baseline. The patient has also experienced an increase in the duration of their partial complex seizures that used to last about 5 minutes and are now about 15 minutes. The patient had been taking 18 tablets of depakene per day (dosage unknown) but was recently reduced to 6 tablets per day because their blood levels at the higher dosage were reportedly non-therapeutic. The physician does not believe that the increase in seizure activity is related to the reduction of depakene. The patient's device has been programmed to off in 06/2002 and their physician is monitoring patient's blood pressure. Attempts to obtain additional information have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=406396



Title: Re: Increase in seizures
Post by: dennis100 on November 23, 2011, 04:27:29 PM
Model Number 101
Event Date 05/23/2002
Event Type Injury Patient Outcome Disability; Required Intervention
Manufacturer Narrative
Further follow-up revealed that the pt's device was turned on on 2002. The pt's vocal cord paralysis has not been resolved.

Manufacturer Narrative
H. 6. Method: the labeling for the ncp pulse generator lists left vocal cord paralysis as a potential adverse event associated with surgery or stimulation. H. 6. Conclusion: device manufacturing records were reviewed. H. 6. Results: review of manufacturing records confirmed sterilization of devices.

Event Description
Reporter indicated that following vns implant surgery, the patient developed an infection involving the chest incision and also has vocal cord paralysis. Further follow up revealed that the patient did not have an infection after all, but was diagnosed with vocal cord paralysis by an ear, nose, throat dr in 2002. It was reported that hoarseness was noted immediately following the implant surgery. The vocal cord paralysis was reportedly treated with cortizone without success. It is not known at this time whether or not stimulation has been initiated. Attempts to obtain additional information have been unsuccessful to date.

Manufacturer Narrative
Additional information from the patient's follow-up office visits on 09/03/2002, and 10/01/2002 was received and is summarized below: office visit on 09/03/2002: no vocal cord function (movement) on 08/02/2002 per ent physician. No swallowing problems, no change in voice when the patient talks softly, sightly raspy voice, cannot talk out loud. On 08/16/02, the patient had a bad seizure with a tonque bite, anxiety attacks. Physician assessment concluded that the patient's seizure disorder is slightly better. The physician adjusted the vns settings. The next follow-up visit was scheduled for one month. Office visit on 10/01/02: patient reported experiencing a seizure on 09/23/02 and on 09/29/02. The seizure on 09/29/02 occurred during sleep with incontinence, tonque bit and turning purple. The patient's voice is a little better. The physician's assessment concluded poorly controlled seizures, partial with secondary generalization. The vns settings were adjusted. The next follow-up visit was to be in six weeks.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=406423


Title: Re: Increase in seizures
Post by: dennis100 on November 23, 2011, 04:28:18 PM
Model Number 101
Event Date 06/01/2002
Event Type Injury Patient Outcome Life Threatening; Hospitalization Required Intervention
Event Description
Reporter indicated that the patient was seizure-free prior to generator replacement surgery for end of service, but that the patient has experienced four seizures since generator replacement surgery, two of which required visits to the hospital emergency room. At their last emergency room visit (week of 06/2002), the patient's medications were increased. The patient was seen by physician during that week and their device was reportedly on and functioning properly. Physician's office reported that the patient had not been seizure-free prior to re-implant surgery, but that patient had experienced breakthrough seizure all along. The patient is not scheduled to be seen by physician again until september 2002. Investigation to date has been unable to determine whether or not the reported event is related to the ncp system. Attempts to obtain additional information have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=406383


Title: Re: Increase in seizures
Post by: dennis100 on November 23, 2011, 04:29:18 PM
Model Number 101
Event Date 10/01/2001
Event Type Injury Patient Outcome Life Threatening; Required Intervention
Event Description
Initial report indicated that patient was experiencing an increase in seizure activity, but not above pre-vns baseline. It was initially reported that pre-vns implant, the patient suffered multiple seizures per day. The patient did not experience any seizures from the day of implant (in 2001) to the day that stimulation was initiated, the following month. During the month after stimulation was initiated, the patient had 3 seizures. For the next 3 months, the patient experienced an increase in the intensity of seizures and had them daily. There were no medication changes since vns implant, but the patient's programmed parameters were increased in 10/2001 from 0. 25ma output current to 0. 50ma output current. The patient's output current was decreased back to 0. 25ma in january 2002, but it is not known whether this parameter reduction had an impact on the patient's seizure frequency or intensity. It was determined at the time of the intial report that the event did not meet mdr reportability criteria as the seizure increase was not above the patient's pre-vns baseline. Further follow-up revealed that device diagnostic testing in february 2002 was within normal limits, indicating proper device function. It was reported at that time the patient had an increase in seizures since may 2002. Information obtained during further follow-up indicated that the patient's increase in seizure activity was above patient's pre-vns baseline frequency. It was reported that the patient had approximately 10 seizures between 02/2001 and 04/2001, but that now patient is having approximately 1 seizure per night. This information conflicts with the previously reported pre-vns baseline frequency of multiple seizures per day. Attempts to obtain clarification of the patient's pre-vns baseline frequency have been unsuccessful to date.

Manufacturer Narrative
H. 6: device manufacturing records were reviewed. Results: review of manufacturing records did not reveal any anomalies that would have an adverse effect on device performance. The following dates are estimiated. Only the month/year is known: b. 3, date of event.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=405922



Title: Re: Increase in seizures
Post by: dennis100 on November 23, 2011, 04:30:14 PM
Model Number 101
Event Date 11/23/2001
Event Type Injury Patient Outcome Life Threatening;
Manufacturer Narrative
Method: mfg records for the generator and lead were reviewed. Results: no anomalies were noted in the mfg records that could have an adverse effect on device performance. All visual inspection and electrical tests passed prior to shipment.

Manufacturer Narrative
Further follow-up revealed that the patient's device was programmed to off on 07/30/2002. The patient experienced a total of 29 seizures in a sixty day period after programming the device to off. The physician plans to keep the device programmed to off for 120 days and the reassess the patient's condition to determine if vns therapy will be continued. H. 6. Method: x-rays were reviewed. Reuslts: review of x-ray did not reveal any anomalies that would adversely effect device performance.

Event Description
The reporter indicated that the pt has had an increase in seizures post-implant. The device was implanted in 2001. On 2001, the device was programmed to 0. 25 ma and the pt's seizure activity did not change from their baseline activity. On 10/2001, the output was increased to 0. 50 and the pt still maintained their baseline activity. The following month, the output was increased to 0. 75 and the pt began to have an increase in seizures. In 12/2001, the output was increased to 1. 00 and the seizure activity was less; however, it was still two lines the baseline activity. The pt's facility feels that the device is not working properly; however, the device was tested and found to be working properly. It was reported that there have been no medication or environmental changes that may have led to the increase in seizures. Attempts to obtain add'l info have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=404221



Title: Re: Increase in seizures
Post by: dennis100 on November 23, 2011, 04:33:36 PM
Date 05/17/2002
Event Type Injury
 Patient Outcome Life Threatening; Hospitalization Required Intervention
Event Description
Reporter indicated that pt experienced a 5-hour episode of status which required hospitalization and a reduction in device settings. It was reported that the pt initially experienced a dramatic decrease in seizures with the vns, but increases to device settings seemed to worsen the pt's seizure activity. The pt's generator was programmed to on approximately one week post-implant to the following settings: 0. 50ma output current, 30 seconds on, 5 minutes off. Two minutes later, the programmed settings were increased to 1. 0 ma output current, 4 minutes off (on time remained the same). With the next parameter increase to following parameters: 2. 0ma output current; 45 seconds on; 2 minutes off, the pt experienced a day of clusters and their seizures worsened to the point of the status episode. At the last device settings (2. 0ma output current), it was noted that the pt coughed constantly, was short of breath, and experienced horseness. At the time of hospitalization, the device output current was reduced to 1. 25ma. Since this parameter reduction, the pt did not experience any further seizures for at least 2 days. The pt denies any traumatic brain injury and states that there were no medication changes during the time of the reported event. Attempts to obtain add'l info have been unsuccessful to date.

Manufacturer Narrative
Further follow-up revealed that the patient's device was programmed to off after experiencing coughing and hoarseness shortly after implant. It was reported that after a period of time the device was programmed back to on wihtout any further problems. It was reported that the patient is having great seizure control.

Manufacturer Narrative
Conclusion: device labeling states that "pt's whose seizures are well controlled at follow-up should not have their settings changed unless they experience uncomfortable side effects. ".

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=401108



Title: Re: Increase in seizures
Post by: dennis100 on November 23, 2011, 04:34:40 PM
Model Number 100
Event Date 02/01/2002
Event Type Malfunction Patient Outcome Life Threatening;
 Manufacturer Narrative
Further follow-up revealed that the pt is able to stop the seizures using the magnet. H. 6. Method: device mfg records for the pulse generator were reviewed. H. 6. Results: review of mfg records for the pulse generator did not reveal any anomalies nor abnormalities that would have an adverse effect on device performance.

Manufacturer Narrative
Method: device manufacturing records for the bipolar lead were reviewed. Results: review of manufacturing records for the bipolar lead did not reveal any anomalies nor 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 has been implanted for almost three years and has reportedly been seizure-free for 14 months. It was reported that for the past few months, the patient has had an increase in seizure activity and can no longer perceive stimulation. The reporting physician increased the patient's device output current to 3. 5ma and the patient still did not feel the stimulation. Device diagnostic testing was within normal limits and the eri (elective replacement indicator) flat was no, indicating that the generator was not at end of service. The reporter was not the patient's usual neurologist. The reporter was unfamiliar with the patient's history and felt that the history obtained from the patient and their family may be unreliable. Reporting physician plans to refer the patient back to their usual neurologist. Patient's inability to perceive stimulation may indicate device malfunction. Attempts to obtain add'l info have been unsuccessful to date.


Manufacturer Narrative
Further follow-up revealed that the pt has only had one breakthrough seizure since having her medications changed on 05/2002, which was caused by a missed drug dose. The pt is reported to be doing well. The physician reported that the pt was able to feel stimulation when the pt left the physician's office the day of the reported event.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=401710



Title: Re: Increase in seizures
Post by: dennis100 on November 23, 2011, 04:35:55 PM
Model Number 101
Event Date 05/01/2002
Event Type Injury Patient Outcome Hospitalization; Required Intervention
Manufacturer Narrative
The following dates are estimated. Only the month/year is known: b. 3, date of event.

Event Description
Reported indicated that patient has experienced an increase in seizure activity since generator replacement surgery. The patient's generator was replaced due to end of service on 4/2002. Since then, the patient's seizures have gotten worse; patient had three seizures in 5/02, four on the following day, and eight the next day. Swiping the magnet over the device does not help even though it used to abort the seizures. There have been some medication changes, but these occurred after the increase in seizures in hopes of regaining seizure control. Depakote, phenobarbital, and topamax have been increased. Pre-vns, the patient had "tons" of seizures including grand mal, partials, etc. After pt's implant, patient was seizure free for two years and then started having one seizure per month which is when they decided to replace the unit. Since the re-implant in 2002, patient has had atleast 17 seizures.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=399130



Title: Re: Increase in seizures
Post by: dennis100 on November 23, 2011, 04:36:44 PM
Event Date 04/01/2002
Event Type Injury Patient Outcome Life Threatening; Hospitalization Required Intervention
Manufacturer Narrative
H. 6. Method: device programming history was reviewed. Results: review of device programming history did not reveal any anomalies or abnormalities.

Manufacturer Narrative
Method: device mfg records were reviewed. Results: review of mfg records did not reveal any anomalies nor abnormalties that would have an adverse effect on device performance. Conclusion: normal end of service is presumed due to aggressive device settings and apparent resolution following generator replacement.

Event Description
Reporter indicated that pt has experienced an increase in seizures over the past month. Diagnostic testing of pt's device in 5/2002 resulted in high lead impedance reading (dc-dc code 7 and limit), indicating possible device malfunction. The eri (elective replacement indicator) flag was no, indicating that the generator was not at end of service. Previous device diagnostic testing in february 2002 resulted in normal lead impedance readings, indicating proper device function at that time. The pt feels the stimulation. Lead malfunction is not suspected. The physician believed that the generator may be nearing end of service and could no longer be able to deliver the 1. 5ma output current as programmed. Further follow-up revealed that the pt fell from a seizure prior to the 5/02 office visit and that bruises on pt's body were observed at that time. It was reported that the pt's motivation was greatly decreased in the past couple of months. The pt's generator was replaced at the pt is reportedly doing well. Diagnostic testing of the ncp system after generator replacement surgery was within normal limits. No x-rays taken prior to generator replacement surgery. Attempts to obtain additional info have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=398432



Title: Re: Increase in seizures
Post by: dennis100 on November 23, 2011, 04:37:47 PM
Model Number 101
Event Date 09/01/2001
Event Type Injury Patient Outcome Required Intervention;
Manufacturer Narrative
Further follow-up revealed that the patient was still having breakthrough seizures at an office visit on 06/2002. A chest x-ray was ordered and confirmed that the device was normal and that it is was not protruding. Device manufacturing records were reviewed. Device programming history was reviewed. Review of device manufacturing records did not reveal any anomalies nor abnormalities that would have an adverse effect on device performance. Review of device programming history did not reveal any anomalies nor abnormalities.

Event Description
During the process of contacting the pt, it was discovered that the pt has had a dramatic increase in starring spells. It was reported that the pt suffered a fall in 07/2001 during which pt sustained a basal skull fracture at the right posterior ear. The pt's generator was replaced 2 mos later due to end of service. Around the second week of 9/2001, the starring spells increased dramatically. It also appears that the placement of the pt's new generator is awkward and that it protrudes when the pt raises their arm. Further follow-up revealed that the pt was last seen by physician on 10/2001 at which time steroids were prescribed to help with the starring spells. It was reported that the pt is back down to their baseline number of starring spells and is still taking the steroids. In regards to the generator protrusion, the pt's family member reports that the placement of the new generator looks to be more protruding than the original generator. The pt's family member does not believe that the generator will come through the skin, but it does appear to be closer to the skin than the previous generator. The pt does not show any signs of discomfort with the new generator. It was reported that a different neurosurgeon placed the second generator. Attempts to obtain additional info have been unsuccessful to date. The pt is not scheduled to see the physician again until 6/2002.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=396154



Title: Re: Increase in seizures
Post by: dennis100 on November 23, 2011, 04:38:44 PM
Event Type Injury Patient Outcome Life Threatening;
Event Description
Reporter indicated that patient's seizures worsened following vns implant. It was reported that the patient had daily complex partial seizures pre-vns and that after the vns implant, the patient began convulsing much worse than before. Attempts to obtain additional information has been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=398141


Title: Re: Increase in seizures
Post by: dennis100 on November 23, 2011, 04:48:07 PM
Model Number 101
Event Date 04/01/2002
Event Type Injury Patient Outcome Life Threatening; Required Intervention
Manufacturer Narrative
H. 6. Conclusions: physician indicated that the event has resolved.

Manufacturer Narrative
The following dates are estimated. Only the month/year is known: b. 3, date of event.

Event Description
Reporter indicated that since receiving the vns implant, the pt has not experienced any grand mal seizures. It was reported that over the past few weeks, the pt has been experiencing 2-3 grand mal seizures a day. It was also reported that the pt's magnet is no longer an effective way to abort the pt's seizures. The change in seizure activity started around the same time the pt's felbatol dosage was increased. The pt has lennox gastaut syndrome and cannot say whether or not pt feels pain. Further f/u ce. This may have led to a no output condition and therefore the pt would not have been receiving therapy. Attempts to obtain add'l info have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=396185



Title: Re: Increase in seizures
Post by: dennis100 on November 23, 2011, 04:49:38 PM
Event Date 03/01/2002
Event Type Injury Patient Outcome Life Threatening; Required Intervention
Manufacturer Narrative
The following dates are estimated. Only the month/year is known: b. 3, date of event.

Event Description
Reporter indicated that the patient was going to have the device replaced after having it implanted for less than one year. Further follow-up revealed that the device was being explanted due to an increase in seizures and urinary incontinence. The patient has been having multiple seizures a day, everyday for the past two months along with incontinence. The device settings have not been altered and there were no medication changes prior to the increase in seizure activity. An increase in medications and device parameters over the past two months has not helped the situation. The patient is able to feel stimulation. Device diagnostic tests yield normal results and the eri (elective replacement indicator) flag is no, indicating that the generator is not at end of service. Attempts to obtain additional information have been unsuccessful to date

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=396862


Title: Re: Increase in seizures
Post by: dennis100 on November 23, 2011, 04:50:42 PM
Model Number 100
Event Date 06/29/2001 Event Type Malfunction
Manufacturer Narrative
The pt has changed physicians since the time of the inital report. The new physician was also unable to interrogate the pt's device. It was reported that pt has experienced an increase in seizures and that no voice changes have been apparent for the past 3-6 mos. It was also reported that the pt has not felt the stimulation for a while. At an office visit with new physician on 9/10/01, the device was swiped with the magnet, but the pt stated that he did not feel any stimulation. Attempts to reset the device were unsuccessful as the device would not communicate. The generator was replaced due to suspected end of svc.

Event Description
Reporter indicated tht physician received data transmission error during interrogation of patient. Physician unplugged computer from wall and had no trouble interrogating next patient. Investigation was not able to rule-out potential malfunction or end of service for patient involved in data transmission error.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=396197


Title: Re: Increase in seizures
Post by: dennis100 on November 23, 2011, 04:51:24 PM
Event Date 01/01/2002
Event Type Injury Patient Outcome Life Threatening; Required Intervention
Event Description
Rptr indicated that pt experiences cluster seizures that progress into status if they are not stopped with either the magnet or with administering valium. Attmepts to obtain add'l info have been unsuccessful to date.

Manufacturer Narrative
The following dates are estimated. Only the year is known: b. 3, date of event.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=395717


Title: Re: Increase in seizures
Post by: dennis100 on November 23, 2011, 04:52:12 PM
Model Number 101
Event Date 08/01/2001
Event Type Injury Patient Outcome Life Threatening; Required Intervention
Manufacturer Narrative
Further f/u with the pt's phsyician revealed that the pt is no longer being seen by this physician. The physician did not know who the pt's new physician was. The physician indicated that the pt has some axis ii diagnosis, but would not elaborate citing pt confidentiality. The pt was last seen by this physician on 4/18/2002, but would not tell the physician how many seizures he was having.

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. The following dates are estimated. Only the month/year is known: b3, date of event.

Event Description
Reporter indicated that reporter has experienced hoarseness and an increase in seizures since having the vns implant. It was reported that the pt would have 1 cluster per month pre-vns and that reporter now has 1 cluster every one or two weeks since the vns implant. While speaking with the pt on the telephone at the line of the initial report, mfr rep could tell that the pt's voice was hoarse when the device stimulated as programmed, but the hoarseness was not extreme or any more severe than the average vns pt with this labeled side effect. Further follow-up revealed that the pt's physician had programmed the device to very low settings (date and settings unknown) and then since then, the pt reported that seizures have stopped. It was reported that the pt's medications were constant since vns implant. The pt is considering having the device explanted. Attempts to obtain add'l info have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=395884



Title: Re: Increase in seizures
Post by: dennis100 on November 23, 2011, 04:53:35 PM
Event Date 03/01/2002
Event Type Injury Patient Outcome Life Threatening; Required Intervention
Event Description
Reporter indicated that the patient has been experiencing sleep apnea. In 04/2002, the patient's family member taped the magnet to the device to turn the device off. During this time it was reported that the patient did not experience sleep apnea. On the following day, the device was activated in the morning and the patient began to cough which was reported to cause patient headaches. The patient is reported to have good seizure control with the vns, but not as good as it was in the beginning. The patient's family member did not give permission to contact the patient's physician at this time.

Manufacturer Narrative
The following dates are estimated. Only the month/year is known: b. 3, date of event.

Manufacturer Narrative
H. 6. Conclusions: the patient's family member indicated that the patient's sleep apnea has resolved with the current modifications to the patient's treatment regime.

Manufacturer Narrative
Further follow-up revealed that the patient's seizures have increased from having one every 8 to 10 weeks with no simple seizures to 5 to 10 simple seizures and no complex partial seizure every 5 to 6 weeks. The patient's magnet is "causing the patient to faint" and then the patient is having rebound headaches. The patient is not using the magnet at all even though the settings were reduced "way down" on the magnet. There is some concern over the patient's secondary diagnosis of chiari syndrome affecting the patient's response to the ncp system and causing the rebound headaches. The patient's parent believes that the patient started experiencing an increase in seizures after the vns parameters were increased. The physician feels that the patient's current increase in simple seizures has to do with stress and not from vns therapy.

Manufacturer Narrative
Further follow-up revealed that the pt's device settings were lowered by the physician in early 6/02. The pt's mother reported that the pt has been much more comfortable and is doing excellent with the lower device settings. The physician wants to refer the pt for a sleep study diagnositc test for the pt's apnea. The pt currently tapes the magnet over the device at night and is now waking in the morning feeling refreshed.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=392516



Title: Re: Increase in seizures
Post by: dennis100 on November 23, 2011, 04:54:29 PM
Model Number 300-20
Event Date 03/01/2002
Event Type Malfunction Patient Outcome Life Threatening;
Manufacturer Narrative
Further follow-up revealed that the pt is doing fine since lead replacement surgery. Methods: device programming history was reviewed. Conclusions: review of device programming history was inconclusive in determining a time frame when a lead break could have occurred.

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. The following dates are estimated. Only the month/year is known: b. 3, date of event.

Event Description
Reporter indicated that patient was experiencing an increase in seizures. It was reported that the patient fell during a seizure and has had an increase in seizures since that time. The patient was last seen by physician in may 2001 at which time device diagnostic testing was within normal limits, indicating proper device function at the time. Current device diagnostic testing resulted in high lead impedance reading (dc-dc code 7 and limit), indicating possible device malfunction. Cervical spine x-rays did not reveal any abnormalities or obvious breaks in the lead. Neurosurgeon has recommended lead replacement surgery, but is concerned about damaging the nerve and will not proceed with the surgery until he consults with another neurosurgeon more experienced with vns implants. It was reported that the patient has had great response to the vns therapy. Pre-vns, the patient was very lethargic because of the medications they were taking. The patient was seizure-free for approximately one year following initial vns implants. As a result of the great response to the vns therapy, the patient was taken off of many of their medications. In 2000, the patient started to suffer from 1 to 3 seizures per week. The patient's generator was replaced in 2001 due to end of service. The patient still has about 1 seizure per month (clonic-tonic) which last for about a minute. These seizures caused them to fall and may have contributed to their current problem of high impedance as it is suspected that the lead may be broken.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=392918



Title: Re: Increase in seizures
Post by: dennis100 on November 23, 2011, 04:55:12 PM
Model Number 300-20
Event Date 01/01/1999
Event Type Injury Patient Outcome Life Threatening; Hospitalization Disability Required Intervention
Event Description
In the process of contacting the patient to inform them that their generator may be nearing end of service, it was discovered that the patient's ncp system was explanted due to increased seizures and left vocal cord paralysis. It was reported that the explant took place not long after the device was implanted. Reporter indicated that the patient had a short neck and that there was a problem placing the leads initially. It was also reported that the patient's neurologist kept "turning up the device" too high causing left side of the patient's face to twitch followed by choking and coughing when swallowing. It was reported that the ear, nose, throat who explanted the device felt that the high setting was the cause of the vocal cord paralysis. It was reported that the patient continues to suffer from the vocal cord problems. Further follow-up revealed that the patient's lead was replaced in 1999 and that the explant of the ncp system took place after that time (date unknown). Attempts to obtain additional information have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=395764


Title: Re: Increase in seizures
Post by: dennis100 on November 23, 2011, 04:59:09 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


Title: Re: Increase in seizures
Post by: dennis100 on November 23, 2011, 04:59:46 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



Title: Re: Increase in seizures
Post by: dennis100 on November 23, 2011, 05:00:24 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



Title: Re: Increase in seizures
Post by: dennis100 on November 23, 2011, 05:01:02 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



Title: Re: Increase in seizures
Post by: dennis100 on November 23, 2011, 05:01:40 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



Title: Re: Increase in seizures
Post by: dennis100 on November 23, 2011, 05:02:22 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



Title: Re: Increase in seizures
Post by: dennis100 on November 23, 2011, 05:04:05 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


Title: Re: Increase in seizures
Post by: dennis100 on November 23, 2011, 05:05:51 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


Title: Re: Increase in seizures
Post by: dennis100 on November 23, 2011, 05:07:23 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


Title: Re: Increase in seizures
Post by: dennis100 on November 23, 2011, 05:08:10 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



Title: Re: Increase in seizures
Post by: dennis100 on November 23, 2011, 05:08:56 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



Title: Re: Increase in seizures
Post by: dennis100 on November 23, 2011, 05:09:40 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


Title: Re: Increase in seizures
Post by: dennis100 on November 23, 2011, 05:10:32 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



Title: Re: Increase in seizures
Post by: dennis100 on November 23, 2011, 05:11:12 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



Title: Re: Increase in seizures
Post by: dennis100 on November 23, 2011, 05:11:55 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



Title: Re: Increase in seizures
Post by: dennis100 on November 23, 2011, 05:12:45 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




Title: Re: Increase in seizures
Post by: dennis100 on November 23, 2011, 05:24:02 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 the patient could no longer feel stimulation and that their seizures have increased.  

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



Title: Re: Increase in seizures
Post by: dennis100 on November 23, 2011, 05:37:49 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



Title: Re: Increase in seizures
Post by: dennis100 on November 23, 2011, 05:40:11 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



Title: Re: Increase in seizures
Post by: dennis100 on November 23, 2011, 05:40:53 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


Title: Re: Increase in seizures
Post by: dennis100 on November 24, 2011, 01:23:45 PM
Model Number 101
Event Date 08/01/2002
Event Type Injury Patient Outcome Life Threatening;
Manufacturer Narrative
Further follow-up revealed that the pt did not experience an increase in seizures as initially reported. The pt has had improvement in seizure control with the ncp system. The physician indicated that the pt's chest pain has improved since lowering device settings on 9/24/2002.

Manufacturer Narrative
Attempts to obtain additional info have been unsuccessful to date. The pt's regular neurologist is out on medical leave.

Event Description
Reporter indicated that the pt is experiencing severe chest pain at the generator site and an increase in seizures. The pt was seen by physician in 2002. Device diagnostic testing at office visit was within normal limits, indicating that the device was functioning properly. Physician believes that the event may be due to scar tissue and suggested that the pt follow-up with neurosurgeon. Investigation to date has been unable to determine the severity of the chest pain or whether the seizure increase is above the pt's baseline seizure frequency.

Manufacturer Narrative
Further follow-up revealed that the patient experienced an increase in seizures in early august; however, the cause was reported to be usual breakthrough seizures and that they were less severe. H. 6 method: device programming history was reviewed. Results: review of device programming history revealed no anomalies.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=416506



Title: Re: Increase in seizures
Post by: dennis100 on November 24, 2011, 07:25:46 PM
Model Number 100
Event Date 01/01/2000
Event Type Injury Patient Outcome Required Intervention;
Event Description
In the process of notifying the pt that the device may be nearing end of service, it was discovered that the pt's device was programmed to off two years ago due to an increase in seizures. Attempts to obtain additional info have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=414480



Title: Re: Increase in seizures
Post by: dennis100 on November 24, 2011, 07:26:52 PM
Model Number 100
Event Date 03/01/2002
Event Type Injury Patient Outcome Life Threatening; Hospitalization Required Intervention
Event Description
In the process of contacting the pt's physician to notify pt that the pt's device may be nearing end of service, it was discovered that the pt experienced an increase in seizures. The pt had reportedly fallen and broken their arm. It was reported that the pt's seizures were not being controlled by their medications and that prior to 2002, their seizures were under much better control with the vns therapy. The pt's generator was replaced 5 months later. Normal end of service is suspected; however, investigation to date has been unable to rule-out possible device malfunction as the cause of the event. Attempts to obtain add'l info have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=412623



Title: Re: Increase in seizures
Post by: dennis100 on November 24, 2011, 07:28:49 PM
Model Number 102
Event Date 11/28/2002 Event Type Injury
Patient Outcome Life Threatening;
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
The magnet was used at the onset of a seizure and the patient indicated that their chest and throat hurt and then the patient became cyanotic. This reportedly occurred on two occasions. The patinet's programmed parameters were changed and the magnet had been used daily since then without incident. The magnet was tested before leaving the physician's office at the time that the adjustment in parameters was made, also without incident. Physician advised patient not to use magnet until manufacturer completes a review of the reported information. Physician is considering reducing the magnet pulse width to a more tolerable setting. No device malfunction is suspected.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=435937



Title: Re: Increase in seizures
Post by: dennis100 on November 24, 2011, 07:29:52 PM
Model Number 101
Event Date 11/01/2002
Event Type Injury Patient Outcome Life Threatening; Required Intervention
Manufacturer Narrative
The following dates are estimated. Only the month/year is known: b. 3 date of event.

Event Description
Reporter indicated that the pt's device had been programmed to off due to an increase in seizures. It was also reported that the pt almost went into status while the device was programmed on. The pt is scheduled to have the device programmed back to on at lower device settings in january 2003.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=435439


Title: Re: Increase in seizures
Post by: dennis100 on November 24, 2011, 07:31:21 PM
Model Number 300-20
Event Date 07/01/2002
Event Type Malfunction
Patient Outcome Life Threatening; Hospitalization Required Intervention
Event Description
Reporter indicated that device diagnostic testing at office visit on 07/25/02 resulted in high lead impedance reading (dc-dc code 7 and limit), indicating possible device malfunction. The pt is reportedly not a reliable source to verify whether pt is still feeling stimulation due to their cognitive level. At office visit on 07/25/02, it was reported that the pt experienced an increase in seizure activity over the past two weeks. The frequency increased from 1 seizure every other week to 1-2 seizures per week for at least 2 weeks. The physician indicated that he suspected a lead break because the pt has had numerous falls that may have damaged the ncp system. Since the pt was leaving to go to long-term rehabilitation for behavioral problems, the neurologist arranged for ncp replacement surgery before pt left. Both the lead and generator were replaced per mfr's recommedations as the generator was clearly continuing to produce current across the broken leads, therefore exhausting itself. The operative report indicated that cervical and chest x-rays identified frayed, fractured leads. When the generator was removed, the surgeon noticed that the lead had coiled around itself near the generator site. Further follow-up revealed that the pt is reportedly doing well since ncp system replacement surgery. Attempts to facilitate return of explanted products for analysis have been unsuccessful to date.

Manufacturer Narrative
H6. Method: device mfg records were reviewed. Device programming history was reviewed. Results: review of mfg records did not reveal any anomalies that would have an adverse affect on device performance. Review of programming history revealed no anomalies. High lead impedance reading on 07/2002 was confirmed. Previous device diagnostic test results on 04/2002 were within normal limits. Pt suffered numerous falls that are believed to have caused the reported lead break.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=413293



Title: Re: Increase in seizures
Post by: dennis100 on November 24, 2011, 07:33:25 PM
Model Number 300-20
Event Date 05/01/2002
Event Type Malfunction
Patient Outcome Life Threatening;
Manufacturer Narrative
Further follow-up revealed that the pt had revision surgery on 8/23/2002 to replace the generator. Lead test on the day of the revision surgery resulted in nominal readings. The explanted device will not be returned for analysis.

Manufacturer Narrative
H. 6: device manufacturing records were reviewed. Available device programming history was reviewed. Review manufacturing records did not reveal any anomalies that would have an adverse effect on device performance. Review of limited device programming history was inconclusive in determining a timeframe in which the suspected device malfunction may have occurred. The portion of programming history reviewed did not reveal any abnormalities. No diagnostic data was available. Review of x-rays by neurosurgeon revealed a break in the lead. Lead and the generator be positioned on the left side of the body. The following dates are estimated. Only the month/year is known: b. 3, date of event.

Event Description
Reporter indicated that patient has not felt stimulation for "a couple of months" and has experienced an increase in seizures. Device diagnostic testing resulted in high lead impedance reading (dc-dc code 7 and limit), indicating possible device malfunction. The eri (elective replacement indicator) flag was no, indicating that the patient's generator was not at the end of service. The patient's lead is implanted on the left vagus nerve, but the generator is implanted on the right side of the chest since the patient has another implanted device on the left. Further follow-up revealed that surgery is scheduled for 2002 to replace both the generator and lead.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=412138


Title: Re: Increase in seizures
Post by: dennis100 on November 24, 2011, 07:34:14 PM
Model Number 100
Event Date 07/05/2002
Event Type Injury Patient Outcome Life Threatening; Hospitalization Required Intervention
Manufacturer Narrative
H. 6: device manufacturing records were reviewed. H. 6: review of manufacturing records did not reveal any anomalies that would have an adverse effect on device performance.

Event Description
Reporter indicated that patient experienced an increase in seizures and was subsequently hospitalized. The patient was reportedly receiving benefit from the vns therapy until the event date, when the increase in seizure activity began. The patient's seizure activity has increased from 2 seizures per week to 32 per day. Device diagnostic testing was within normal limits, indicating proper device function. It was reported that the device seems more movable in the chest wall. The patient's family member reports that magnet swipes are now felt intermittently. Prior to the event, the patient would always cough during a magnet swipe, but now the coughing response is intermittent. Further follow-up revealed that x-rays taken four days later revealed no discontinuities in the ncp system. The patient's generator was replaced 6 days later. The lead was not replaced. The new generator was programmed to on the same day and the patient was reported to be doing better. Site was unwilling to download device programming history for review since the patient had been programmed on several different computers. It was reported that the patient's device was programmed to the same settings for the past 8 months. Using the last reported device settings, the projected life of the device was determined. The expected battery life at the known device settings was calculated to be from 1. 80-6. 57 years. At the time of event, the device had been implanted for approximately 2. 4 years. The actual life of the battery was well within the calculated range as determined with known device settings. Normal end of service is suspected. The device was discarded and is not available for analysis.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=408881



Title: Re: Increase in seizures
Post by: dennis100 on November 24, 2011, 07:35:03 PM
Model Number 101
Event Date 06/01/2002
Event Type Injury Patient Outcome Life Threatening; Hospitalization Required Intervention
Manufacturer Narrative
H. 6: device manufacturing records were reviewed. X-rays were reviewed. Device programming history was reviewed. H. 6: review of manufacturing records did not reveal any anomalies that would have an adverse effect on device performance. Review of x-rays taken in 7/2002 revealed that the positive lead connector pin was not properly connected to the generator and that adequate strain relief was not present around generator site. Review of available programming history did not reveal any anomalies. The following dates are estimated. Only the month/year is known: b. 3, date of event.

Event Description
Reporter indicated that patient experienced an increase in seizure activity. Device diagnostic testing resulted in high lead impedance reading (dc-dc code 7 and limit), indicating possible device malfunction. Elective replacement indicator (eri flag) was no, indicating that the generator was not at end of service. The patient's generator was replaced in august 2001 due to end of service. The patient reportedly had good seizure control prior to the re-implant and immediately after, but has recently had an increase in seizure activity. Further follow-up revealed that x-rays taken on 7/2002 showed that the leads were not connected properly to the generator. The patient underwent revision surgery in 2002. Reporter stated that the generator was causing strain on the lead when the pt moved around. The physician reconnected the leads and repositioned the generator. After revision surgery, device diagnostic testing was within normal limits. The patient's device was programmed to on after surgery. It was reported that the patient is no longer experiencing the increase in seizure activity.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=408888



Title: Re: Increase in seizures
Post by: dennis100 on November 24, 2011, 07:36:08 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



Title: Re: Increase in seizures
Post by: dennis100 on November 24, 2011, 07:37:21 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


Title: Re: Increase in seizures
Post by: dennis100 on November 24, 2011, 07:38:10 PM
Model Number 300-30
Event Date 07/01/2000
Event Type Injury Patient Outcome Life Threatening;
Manufacturer Narrative
Method: device manufacturing records were reviewed. X-rays were reviewed. Results: review of manufacturing records did not reveal any anomalies nor abnormalities that would have an adverse effect on device performance. Review of x-rays revealed that no strain relief loop was seen and that one of the lead bodies appeared to be off of the nerve. The electrodes did not appear properly aligned or parallel.

Event Description
Reporter indicated that the patient experienced pain in their shoulder after implant. The patient reportedly had good seizure control initially, but has experienced an increase in seizures over the past few months. Device diagnostic testing (date unknown) resulted in high lead impedance reading (dc-dc code 7), indicating possible device malfunction. The patient reports that they no longer consistently feel stimulation. A discontinuity in the ncp system is suspected. Review of x-rays did not reveal any obvious fracture or discontinuity, however, one of the electrodes appears to be off of the nerve. The electrodes do not appear to be properly aligned. Further follow-up revealed that the patient fell on their forehead in late 2001 or early 2002. The patient began to experience an increase in seizures after they fell. Physician is unsure whether or not the increase in seizure is similar to the patient's pre-vns baseline. The patient reportedly suffered a grand mal seizure in march 2002. It was also reported that the patient underwent some type of physical therapy for the pain in their shoulder. It is possible that if the patient's physical therapy included deep massaging or treatment to the neck or shoulder area, that there might be a possibility that the leads were pulled, causing the apparent displacement of the electrode. Attempts to obtain additional information have been unsuccessful to date. The patient is scheduled for a consultation with a neurosurgeon on 07/2002.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=403717



Title: Re: Increase in seizures
Post by: dennis100 on November 24, 2011, 07:39:46 PM
Model Number 101
Event Date 11/23/2001
Event Type Injury Patient Outcome Life Threatening;
Manufacturer Narrative
Method: mfg records for the generator and lead were reviewed. Results: no anomalies were noted in the mfg records that could have an adverse effect on device performance. All visual inspection and electrical tests passed prior to shipment.

Manufacturer Narrative
Further follow-up revealed that the patient's device was programmed to off on 07/30/2002. The patient experienced a total of 29 seizures in a sixty day period after programming the device to off. The physician plans to keep the device programmed to off for 120 days and the reassess the patient's condition to determine if vns therapy will be continued. H. 6. Method: x-rays were reviewed. Reuslts: review of x-ray did not reveal any anomalies that would adversely effect device performance.

Event Description
The reporter indicated that the pt has had an increase in seizures post-implant. The device was implanted in 2001. On 2001, the device was programmed to 0. 25 ma and the pt's seizure activity did not change from their baseline activity. On 10/2001, the output was increased to 0. 50 and the pt still maintained their baseline activity. The following month, the output was increased to 0. 75 and the pt began to have an increase in seizures. In 12/2001, the output was increased to 1. 00 and the seizure activity was less; however, it was still two lines the baseline activity. The pt's facility feels that the device is not working properly; however, the device was tested and found to be working properly. It was reported that there have been no medication or environmental changes that may have led to the increase in seizures. Attempts to obtain add'l info have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=404221



Title: Re: Increase in seizures
Post by: dennis100 on November 24, 2011, 07:40:24 PM
Model Number 101
Event Date 10/01/2001
Event Type Injury Patient Outcome Life Threatening; Required Intervention
Event Description
Initial report indicated that patient was experiencing an increase in seizure activity, but not above pre-vns baseline. It was initially reported that pre-vns implant, the patient suffered multiple seizures per day. The patient did not experience any seizures from the day of implant (in 2001) to the day that stimulation was initiated, the following month. During the month after stimulation was initiated, the patient had 3 seizures. For the next 3 months, the patient experienced an increase in the intensity of seizures and had them daily. There were no medication changes since vns implant, but the patient's programmed parameters were increased in 10/2001 from 0. 25ma output current to 0. 50ma output current. The patient's output current was decreased back to 0. 25ma in january 2002, but it is not known whether this parameter reduction had an impact on the patient's seizure frequency or intensity. It was determined at the time of the intial report that the event did not meet mdr reportability criteria as the seizure increase was not above the patient's pre-vns baseline. Further follow-up revealed that device diagnostic testing in february 2002 was within normal limits, indicating proper device function. It was reported at that time the patient had an increase in seizures since may 2002. Information obtained during further follow-up indicated that the patient's increase in seizure activity was above patient's pre-vns baseline frequency. It was reported that the patient had approximately 10 seizures between 02/2001 and 04/2001, but that now patient is having approximately 1 seizure per night. This information conflicts with the previously reported pre-vns baseline frequency of multiple seizures per day. Attempts to obtain clarification of the patient's pre-vns baseline frequency have been unsuccessful to date.

Manufacturer Narrative
H. 6: device manufacturing records were reviewed. Results: review of manufacturing records did not reveal any anomalies that would have an adverse effect on device performance. The following dates are estimiated. Only the month/year is known: b. 3, date of event.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=405922



Title: Re: Increase in seizures
Post by: dennis100 on November 24, 2011, 07:42:27 PM
Event Date 07/01/2002
Event Type Injury
Patient Outcome Life Threatening; Required Intervention
Event Description
Reporter indicated that pt's seizures worsened following vns implant. Device parameter adjustments have reportedly not resolved the event.

Manufacturer Narrative
The report is incomplete due to the anonymous nature of the reported event.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=418100



Title: Re: Increase in seizures
Post by: dennis100 on November 24, 2011, 07:43:09 PM
Model Number 101
Event Date 05/22/2002
Event Type Injury Patient Outcome Hospitalization; Required Intervention
Event Description
Reporter indicated that within a few hours of initiating stimulation, the patient's left arm began twitching. Stimulation was initiated approximately two weeks post-implant. The patient then developed a fever of 104 degrees f. The patient was taken to the emergency room where testing for infection was negative. The specifics of the testing are unknown. The patient's device was programmed to off at office visit on 6/18/2002. Within a few hours, the patient was doing fine again. Investigation to date has been unable to determine whether or not the event is related to the ncp system. Further follow-up with physician revealed that the patient's device was programmed to off per the request of the patient's family due to an increase in comatose-type seizures. Neither the arm twitching nor fever were reported to the patient's physician. Physician was not sure whether the increase in seizures was related to the vns. There have been no medication changes since vns implant. There are no plans to re-program the patient's device to on due to a disagreement between family members regarding the patient's care.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=406391


Title: Re: Increase in seizures
Post by: dennis100 on November 24, 2011, 07:43:56 PM
Model Number 101
Event Date 06/01/2002
Event Type Injury Patient Outcome Life Threatening; Required Intervention
Event Description
Reporter indicated that since vns implant, the patient's seizure frequency has increased above its pre-vns baseline. In 2002, the patient reportedly had 12 seizures. The count has gradually increased from month to month. In september 2002 the patient had approximately 52 by their family member's count. The patient is also vomiting quite often, but the vomiting does not coincide with stimulation. The patient vomits on average approximately 5 times per week. The patient's neurologist programmed the normal mode output current to off in 9/2002. The magnet mode output current remains on because this mode seems to be doing good for seizures that they notice and try to abort. Health professional's assessment is that pre-vns, the patient was experiencing multiple seizure types several times a day and vomiting daily. Post-vns, the patient had a "decrease" of multiple seizure types but the vomiting continued. The physician reported the patient is medically complex and response to vns therapy is questionable. The device was turned off in 9/02 and since then, nausea has improved significantly but the number of seizures remains increased.

Manufacturer Narrative
Report is incomplete because attempts to obtain additional information have been unsuccessful to date. The following dates are estimated. Only the month/year is known: b. 3, date of event.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=426138




Title: Re: Increase in seizures
Post by: dennis100 on November 24, 2011, 07:44:59 PM
Model Number 300-20
Event Date 01/01/2002
Event Type Malfunction
Event Description
Reporter indicated that device diagnostic testing at office visit resulted in high lead impedance reading (dc-dc code 7 and limit), indicating possible device malfunction. The elective replacement indicator was "no", indicating that the generator was not at end of svc. Further follow-up revealed that pt's office visit prior to the 9/02 was on 3/02. In march, it was reported that pt was having clusters of 3 to 5 episodes involving a slow drop of the head, shallow breathing, and unresponsiveness which occurred usually in the morning following heavy breathing and hand ringing. Clusters would also happen in the afternoon and shortly before bedtime. Physician's notes from the pt's 9/02 office visit indicate that the pt seizes frequently, and has blank staring episodes with 4-7 cluster seizures. The pt has not experienced any general tonic-clonic seizures and no atonic falls to the floor. The pt has not been able to activate the device using the magnet, which was previously used to abort generalized tonic-clonic seizures. Because the pt's baseline seizure history is unknown, it is unknown if the pt is experiencing an increase in seizures. Lead break is suspected. X-rays did not reveal any discontinuities in the ncp system. Ncp system replacement is planned but not yet scheduled.

Manufacturer Narrative
H. 6. Method: device manufacturing records were reviewed. Results: review of manufacturing records revealed no anomalies that would adversely effect device performance.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=424998



Title: Re: Increase in seizures
Post by: dennis100 on November 24, 2011, 07:46:20 PM
Model Number 300-20
Event Date 08/01/2002
Event Type Injury Patient Outcome Life Threatening; Hospitalization Required Intervention
Event Description
Reporter indicated that pt came into physician's office in 2002 in status. Device diagnostic testing at office visit resulted in high lead impedance readings (dc-dc code 7), indicating possible device malfunction. During device replacement surgery, diagnostic testing of original generator was within normal limits. The physician reported that the original lead was the cause of the high impedance readings. Lead break is suspected. Both the lead and generator were replaced. Further follow revealed that during an office visit in 2002, the pt was reportedly doing fine and there was no indicationn that the pt was having problems. No lead test was performed during this visit. Since vns, the pt's quality of life was significantly better. Pt had a decrease in seizures and would experience only a flurry of seizures about once per month. However, there was a decrease in seizure control after 08/2002 and prior to 09/2002. After the 08/2002 visit, the pt fell in the bathroom and hit their forehead. The physician felt that this fall may have contributed to a lead break. The pt since the fall has had 3 to 4 grand mal seizures and in 2002, the pt had to go to the emergency room because they were in status. In addition, the nurse reported that the pt has been doing well since surgery in 2002.

Manufacturer Narrative
H. 6. Method: device manufacturing records were reviewed. Results: review of manufacturing records for both the bipolar lead and the pulse generator revealed no anomalies that would adversely effect device performance.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=422814




Title: Re: Increase in seizures
Post by: dennis100 on November 24, 2011, 07:47:35 PM
Event Date 11/01/2002
Event Type Malfunction
Patient Outcome Life Threatening;
Manufacturer Narrative
Further follow-up revealed that a lead break at the clavicle was confirmed. X-ray were taken and reviewed by pt's surgeon. Surgeon's office indicated that the pt is scheduled for re-implant on 03/03.

Event Description
Reporter indicated that pt is experiencing an increase in seizure activity (20-30 seizures per day). It is not known at this time whether it is an increase since vns implant, or if the increase is above the pt's pre-vns baseline frequency. It was later reported that the pt is now experiencing neck and chest pain with a shocking feeling. The pt reports that they can no longer feel stimulation. Device diagnostic testing at office visit resulted in high lead impedance reading (dc-dc code 7 and limit), indicating possible device malfunction. Lead break is suspected. Neurologist plans to perform x-rays to rule-out any discontinuities in the ncp system.

Manufacturer Narrative
Further follow up revealed that the patient has not been seen for follow up since her last appointment in 2003. The patient has not called the physician's office with any problems. H 6: scanning electron microscopy was performed. Continuity check using a multimeter was performed. Scanning electron microscopy identified that the break occurred while stimulation was present as evidenced by the pitting on the broken coil wire surfaces. Continuity check did not identify any discontinuities on the remaining protions of the lead returned. Other conditions of the lead were consistent with conditions that exist after the explant procedure. Concomitant device was also returned and analyzed. The pulse genertor met electrical test specifications. No anomalies were identified that would have an adverse effect on device performance.

Manufacturer Narrative
Further follow-up revealed that the pt underwent ncp system replacement on 3/11/03. Device diagnostic testing following replacement surgery was within normal limits. The pt reported to the physician that she is not having any problems. The pt is scheduled to see the physician for a follow-up appointment on 4/23/03.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=435462



Title: Re: Increase in seizures
Post by: dennis100 on November 24, 2011, 07:49:16 PM
Model Number 100
Event Date 10/04/2002
Event Type Death Patient Outcome Death;
 Manufacturer Narrative
H. 6. Conclusions: physician indicated that the ncp system was not related to the cause of death.

Event Description
In the process of contacting the pt's physician to notify them that their pt's device may be nearing end of service, it was discovered that the pt had passed away. Circumstances of death are described by physician as sepsis and/or respiratory compromise. It was reported that the pt's seizure frequency/intensity was greatly decreased with vns therapy, but that as the pt's health was failing, their seizures increased. The pt was receiving vns therapy at the time of death. No autopsy was performed.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=429237



Title: Re: Increase in seizures
Post by: dennis100 on November 24, 2011, 07:50:19 PM
Model Number 101
Event Date 10/05/2002
Event Type Death Patient Outcome Death;
Manufacturer Narrative
Concomitant device was also returned and analyzed. A continuity check using a maltimeter was performed. Continuity check did not identify an discontinuities on the portion of the lead returned. Other conditions of the lead were consistent with conditions that exist after the explant procedure. No material or manufacturing anomalies that could have an adverse effect on device performance were identified.

Manufacturer Narrative
Report is incomplete because requested autopsy report and ceritifcate of death have not been made available to date. H. 6. Method: available device programming history was reviewed. Device manufacturing records were reviewed. Results: review of programming history from 04/2002 through 07/2002 did not reveal any anomalies. Review of manufacturing records for both the pulse generator and the bipolar lead revealed no anomalies that would adversely effect device performance. Conclusions: physician indicated that ncp system was not related to cause of death.

Event Description
Reporter indicated that vns patient had passed away. The patient reportedly became febrile during the daytime. At 9:05pm, pt had the first seizure which spontaneously subsided. The patient had another seizure ten minutes later and then died. The patient reportedly experienced no change in seizure frequency with the vns therapy. The patient was receiving vns therapy at the time of death.

Manufacturer Narrative
Further follow-up revealed that the physician indicated that the pt may have died of sudep.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=429234



Title: Re: Increase in seizures
Post by: dennis100 on November 24, 2011, 08:54:12 PM
Model Number 100
Event Date 08/14/2002
Event Type Malfunction
Event Description
The patient indicated that they were experiencing an increase in seizures and pain. The patient was examined in 2002. At that time, the patient was still having an increase in seizures and pain at the stimulation site. The physician performed a lead test and indicated that the device is working appropriately. This report is being submitted due to theoretical emi anomaly.

Manufacturer Narrative
Device manufacturing records review. Programming history review. Review of device manufacturing records did not reveal any anomalies that would have an adverse effect on device performance. Diagnostic testing in 2002 resulted in nominal readings and eri (elective replacement indicator) is "no". This generator is on the emi feed thru anomaly list.

Manufacturer Narrative
Further follow-up revealed that the pt underwent generator replacement durgery due to suspected end of service on 10/24/2002. Diagnostic testing following generator replacement resulted in nominal readings. The physician's office indicated that pt is doing well.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=417298



Title: Re: Increase in seizures
Post by: dennis100 on November 24, 2011, 09:02:59 PM
Model Number 101
Event Date 03/01/2001
Event Type Injury Patient Outcome Life Threatening; Disability Required Intervention
Event Description
Patient's seizure intensity increased after vns implant. Investigation to date has been unable to determine the significance of the increase in seizure severity and the potential for injury as a result of the severity increase. The patient's drooling reportedly worsened in 2001 following vns implant. Additionally, the patient's seizure severity increased and the patient reportedly experienced urinary incontinence during seizures with the vns therapy. In june 2002, the patient's device was programmed to off in an effort to assess the relationship of the drooling to the vns therapy. There was no evident change in the patient's drooling with the devive several programmed to off. The patient did not have any significant change in seizure control with the vns therapy despite several programming changes before the device was programmed to off. The patient no longer experiences urinary incontinence during seizures with the device programmed to off. In september 2002, the patient's device was programmed back to on for approximately one week. When the incontinence during seizures started, the device was programmed back to off. The patient's ncp system remains off at this time with no plans to program the device back to on. The patient's family member is considering explant of the ncp system.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=430172



Title: Re: Increase in seizures
Post by: dennis100 on November 24, 2011, 09:03:45 PM
Model Number 300-20
Event Date 11/01/2002
Event Type Malfunction
Patient Outcome Life Threatening; Hospitalization Required Intervention
Manufacturer Narrative
H. 6: review of manufacturing records for both the pulse generator and the bipolar lead revealed no anomalies that would adversely effect device performance.

Event Description
The patient had been experiencing vocal cord pain and voice changes. The device output current was decreased in an effort to alleviate the patient's symptoms. After discreasing the device output current, the patient's seizure control worsened. The patient began to have very violent seizures at the lower setting. Device diagnostic testing at office visit resulted in high lead impedance reading (dc-dc code 7 and limit), indicating possible device malfunction. It is believed that the patient's lead may have been damaged as a result of the violent seizures. Lead was replaced and patient is reportedly doing much better

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=433578



Title: Re: Increase in seizures
Post by: dennis100 on November 24, 2011, 09:04:17 PM
Model Number 300-20
Event Date 08/01/2002
Event Type Injury Patient Outcome Life Threatening; Hospitalization Required Intervention
Event Description
Reporter indicated that pt came into physician's office in 2002 in status. Device diagnostic testing at office visit resulted in high lead impedance readings (dc-dc code 7), indicating possible device malfunction. During device replacement surgery, diagnostic testing of original generator was within normal limits. The physician reported that the original lead was the cause of the high impedance readings. Lead break is suspected. Both the lead and generator were replaced. Further follow revealed that during an office visit in 2002, the pt was reportedly doing fine and there was no indicationn that the pt was having problems. No lead test was performed during this visit. Since vns, the pt's quality of life was significantly better. Pt had a decrease in seizures and would experience only a flurry of seizures about once per month. However, there was a decrease in seizure control after 08/2002 and prior to 09/2002. After the 08/2002 visit, the pt fell in the bathroom and hit their forehead. The physician felt that this fall may have contributed to a lead break. The pt since the fall has had 3 to 4 grand mal seizures and in 2002, the pt had to go to the emergency room because they were in status. In addition, the nurse reported that the pt has been doing well since surgery in 2002.

Manufacturer Narrative
H. 6. Method: device manufacturing records were reviewed. Results: review of manufacturing records for both the bipolar lead and the pulse generator revealed no anomalies that would adversely effect device performance.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=422814


Title: Re: Increase in seizures
Post by: dennis100 on November 25, 2011, 02:05:54 AM
Model Number 101
Event Date 01/29/2003
Event Type Injury Patient Outcome Life Threatening; Required Intervention
Manufacturer Narrative
Two attempts have been made to obtain additional information with no response from physician to date. 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
The patient has recently had an increase in seizures and claims that the magnet is not working correctly. In the last two months, the patient has not had any seizures; however in the last two days, the patient has had eight seizures. The patient also reported that the last two days have been very stressful indicating that this may be the cause of the seizure increase. No serious injury was reported due to the increase in seizures. Device diagnostic testing was within normal limits. Indicating that the device is functioning properly. The magnet activations are being counted and confirmed via the device history. Physician plans to increase device normal mode output current form 1. 25ma to 1. 5ma and decrease magnet mode output current from 2. 00ma to 1. 50ma. Investigaion to date has been unable to deteremine whether the increase in seizures is related to the vns.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=445797



Title: Re: Increase in seizures
Post by: dennis100 on November 25, 2011, 02:10:19 AM
Model Number 101
Event Date 01/01/2003
Event Type Injury Patient Outcome Life Threatening;
Manufacturer Narrative
Report is incomplete because no response has been received from physician to manufacturer's requests for additional information to date. 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 the patient has had an increase in seizure activity since their last appointment. At last office visit in december 2002, the physician was not able to interrogate the patient's device. The patient was sent home and it was concluded the wand was not working. The physician received a replacement wand. The patient's family member later reported to the physician that the patient had an increase in seizure activity. Investigation to date has been unable to determine whether the seizure increase is above the patient's pre-vns baseline frequency level. It was also reported that the generator is not stimulating consistently with the programmed settings but that the magnet swipes are working properly.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=444143



Title: Re: Increase in seizures
Post by: dennis100 on November 25, 2011, 02:15:12 AM
Model Number 102
Event Date 09/01/2002
Event Type Injury Patient Outcome Life Threatening; Hospitalization
Manufacturer Narrative
Physician's notes from the (latest) office visit state the following: neurologic: neurologically intact. Appearance: well nourished, well developed, in no acute distress. Chest: lungs clear to auscultation. Cardiovascular: normal s1, s2, no rubs, murmurs or gallops. Abdomen: bowel sounds normal. No distended. Soft. No tenderness or masses. Diagnosis: s/p vns implant, chronic generalized seizures and r/o tegretol toxicity. The pt was to return for a visit in 1 month blood work. The pt was told to see their surgeon for the neck swelling.

Event Description
During the process of a post-implant follow up call with the pt, the mfr's representative learned that the pt is experiencing the following problems: edema in their throat, enlarged veins in their chest area, discomfort in their arm including numbness and tingling, tightness in their chest, and device migration. Further info revealed that during the pt's follow-up visit with their physician, they complained of breakthrough seizures, bowel incontinence, trouble breathing and rash. The pt reported that they were coughing up "yellowish/blood tinged matter. " during subsequent follow-up visits, the pt complained of headaches, ringing in their ears and chronic pain. On the office visit in 2002, the pt indicated that the vns is working well.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=443116



Title: Re: Increase in seizures
Post by: dennis100 on November 25, 2011, 02:17:34 AM
Model Number 102
Event Date 11/01/2002
Event Type Injury Patient Outcome Life Threatening;
Manufacturer Narrative
Further follow-up revealed that the pt has very bad seizures. Physician's office indicated that they have been increasing the pt's programmed parametes, but that it was hard to tell if there has been any improvement since the pt's seizures are so bad. Physician's office reported that the pt seems brighter and more alert. H. 6. : physician indicated that the ncp system is not related to the increase in seizures.

Manufacturer Narrative
Report is incomplete becuase no response has been received from physician to manufacturer's request for additional information to date.

Event Description
Reporter indicated that patient has experienced an increase in seizures since vns implant. The patient's stimulation was initiated in 2002. It was reported that the patient has gone from one seizure per week pre-vns to two seizures per week post-vns. It was also reported that the treating neurologist is slowly increasing the patient's medications. Investigation to date has been unable to determine severity of seizure increase, whether the ncp system caused or contributed to the event, or whether the increase was life-threatening.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=444042



Title: Re: Increase in seizures
Post by: dennis100 on November 25, 2011, 02:19:14 AM
Event Date 01/08/2003
Event Type Injury Patient Outcome Life Threatening;
Manufacturer Narrative
Two unsuccessful attempts have been made to gather further info from the physician.

Event Description
The pt has experienced an increase in their baseline seizure activity since 2003, when the device was programmed on. The device was programmed to 0. 25ma (the lowest setting). It was reported that the pt's device programmed off (date unknown) and that the pt was requesting it be turned back on.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=442863


Title: Re: Increase in seizures
Post by: dennis100 on November 25, 2011, 02:21:18 AM
Model Number 102
Event Date 12/01/2002
Event Type Injury Patient Outcome Required Intervention;
Manufacturer Narrative
Further follow-up revealed that the pt has not called the physician's office with any complaints of problems since having the device programmed back to on on low settings. The pt has not made an appointment to see the physician for follow-up.

Event Description
Physician had programmed pt's device to off. It was reported that in 2002, the pt suffered 8 petit mal seizures and has not been the same since then. The pt was reportedly getting worse every day and was "talking out of their head", shaking and couldn't eat. The pt later reported that the device was causing them to have a non-stop seizure. It was reported that the pt felt as if their eyes were popping out of their head and their family reportedly thought that they were going to kill them. It is not known at this time whether or not the device was programmed to on at this time. Further f/u revealed that when the pt's device was initially programmed to on, they did not have any problems. When programmed parameters were increased, the pt began to have problems with non-stop seizures and change in their behaivor. The pt's family stated that they felt that the pt might hurt themselves, although the pt had not actually attempted to hurt themselves. The pt's symptoms resolved after the device was programmed to off. The pt was considering explant, but has since changed their mind. The pt's device was programmed back to on in 2003 at low settings. Physician plans to leave the pt at these low settings for a while and monitor their progress.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=442896



Title: Re: Increase in seizures
Post by: dennis100 on November 25, 2011, 02:22:03 AM
Model Number 101
Event Date 12/27/2002
Event Type Injury Patient Outcome Life Threatening; Hospitalization Required Intervention
Manufacturer Narrative
H. 6. Conclusions: physician indicated that the vns is not believed to be related to the patient's symptoms.

Event Description
Reporter indicated that vns patient was admitted to the hospital in 2002 and is currently in the icu due to recurring seizures which caused the patient to lose consciousness. The physician plans to program the patient's device to off because he feels that the stimulation is causing the patient bradycardia. Further follow-up revealed that the patient was admitted to the hospital in december to a medicine floor and approximately 7-10 days later was moved to the icu because of blood pressure decrease and bradycardia. The vns was programmed to off in an effort to rule out possible causes. After programming the device to off and administering medication (type not known), the patient's bradycardia resolved. It was also noted that the patient's cortisol level was low. The vns was programmed back to on the next day and the bradycardia did not recur. Physicians reportedly do not believe that the patient's problems are related to the vns.

 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=441938





Title: Re: Increase in seizures
Post by: dennis100 on November 25, 2011, 02:31:07 AM
Model Number 101
Event Date 11/01/2002
Event Type Injury Patient Outcome Life Threatening; Hospitalization
Event Description
The pt had been experiencing an increase in seizures since being accidentally shocked by a car battery in november 2002. The increase in seizures was reported as being above the pt's pre-vns baseline frequency. The pt was seen in the emergency room in 2002 for an episode of status epilepticus. Device diagnostic testing was within normal limits, indicating proper device function. The elective replacement indicator was no, indicating that the generator was not at end of service. Further follow up with physician revealed that the pt had a history of status epilepticus and that the pt's seizure types had not changed since vns implant. The pt reportedly had not had an episode of status since vns implant, where pre-vns they averaged an episode of status every six months. Physician indicated that with vns implant, the pt's seizures are less severe and shorter. The pt has been seen for follow-up twice since hospitalization for status and has been seizure-free since that time.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=441180



Title: Re: Increase in seizures
Post by: dennis100 on November 25, 2011, 02:34:44 AM
Event Date 08/13/2002
Event Type Malfunction
Manufacturer Narrative
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 pt was doing well with good seizure control until 2002 when pt suffered an injury to their chest at the pulse generator site. While closing a car trunk, the pt was hit directly over the pulse generator resulting in pain and ecchymosis. Subsequent to that time, the pt noticed increased seizure activity and increased auras. The pt's device was tested on several occasions and found to be functioning properly; however, the pt noticed that the device had been functioning irregularly in that their voice changes would be quite infrequent. The pt noted multiple times when they required multiple passes of the magnet in order to successfully initiate magnet mode stimulation. Physician originall believed that the pt's symptoms might be related to medication changes and "pulse in and around the area", but there was no improvement over time. The pt's pulse generator was replaced on 3 months later and the pt reports excellent seizure control again with the new device.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=441474



Title: Re: Increase in seizures
Post by: dennis100 on November 25, 2011, 02:35:49 AM
Event Date 01/01/2001
Event Type Injury
Patient Outcome Life Threatening; Hospitalization Required Intervention
Manufacturer Narrative
Report is incomplete due to anonymous nature of reported event. No response to request for add'l info has been received to date.

Event Description
Reporter indicated that pt was hospitalized twice in 2001 for status. The pt reportedly went into status again in the summer of 2002 at which time pt requested that the physician program their vns to off. It was reported that the pt has been seizure-free since programming the device to off.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=440504


Title: Re: Increase in seizures
Post by: dennis100 on November 25, 2011, 02:37:05 AM
Model Number 100
Event Date 12/22/2002
Event Type Injury Patient Outcome Life Threatening; Hospitalization Required Intervention
Event Description
Reporter indicated that pt was admitted to the hosp emergency room in 2002 with an incidence of three seizures. The pt had 2 seizures at the nursing home where pt resides and 1 generalized tonic-clonic activity observed in the emergency room. The emergency room seizure lasted for a few minutes but had a prolonged postictal state. The pt had a tongue bite and urinary incontinence with the emergency room seizure. The pt admitted to recent sinusitis. The pt's device off time was reduced from 10 minutes to 5 minutes and lamictal (50mg po qd) was added to pt's drug regimen in an effort to regain seizure control. The pt was seen by neurologist for follow-up in 2003 at which time the following medication changes were made: lamictal increased from 50mg to 100mg bid, stop topamax 50m bid. Pt's spouse reported emotional changes and forgetfulness since decrease of off time in 2002. No changes were made to device settings. Physician indicated that the device battery was ok. The pt is scheduled to follow-up again with neurologist in 2003.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=439168



Title: Re: Increase in seizures
Post by: dennis100 on November 25, 2011, 02:37:50 AM
Model Number 100
Event Date 01/01/2001
Event Type Death Patient Outcome Death;
Manufacturer Narrative
Further follow up revealed that it is believed that the patient's death was related to a seizure.

Manufacturer Narrative
Report is incomplete because attempts to obtain additional information have been unsuccessful to date. 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
In the process of contacting the patient's physician to notify them that the patient's device may be nearing end of service, it was discovered that the patient had passed away. Exact date and cause of death are unknown at this time. There is no evidence at this time that the ncp system caused or contributed to the reported event.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=438545



Title: Re: Increase in seizures
Post by: dennis100 on November 25, 2011, 02:39:14 AM
Model Number 100
Event Date 12/01/2002
Event Type Injury Patient Outcome Life Threatening; Hospitalization
Manufacturer Narrative
Report is incomplete because attempts to obtain additional information were unsuccessful. Physician indicated that they felt that it was ridiculous that the manufacturer was requesting additional information because the patient made a claim and didn't know what patient was talking about. Physician indicated that they think it's unbelievable that the manufacturer puts this much weight into the patient complaints. Physician indicated that the fact that the manufacturer is required by fda regulations to follow-up patient complaints is preposterous and a waste of time.

Event Description
Patient was hospitalized for 10 days due to an increase in seizure activity. It was reported that prior to the hospitalization, the patient's programmed parameters were set to very low settings. It was also reported that during the patient's hospital stay, the patient's device was programmed to off so that they could undergo an mri. Reporter indicated that after the patient's device was programmed back to on, the patient experienced a shocking feeling from the device. The patient had reportedly been seizure-free for approximately one week at the time of the initial report with the device programmed to very low settings. Further follow-up with physician revealed that there are no longer any problems that the patient is experiencing. It was reported that the shocking feeling must have stopped because that patient would not have been discharged otherwise. Physician indicated that they did not see any problem with the patient or their device and that the patient's complaint was without substance. Physician indicated that the patient's device was disabled approximately 4 years ago (normal mode output current programmed to off) and that only device magnet output current remained active. The increase in seizures reportedly began last year at which time the normal mode output current was reactivated. Physician indicated that the patient complained about a shocking feeling at one point, but the tests were performed that showed that everything was fine and the patient has not complained since. Physician also indicated that the patient's original device had been replaced but did not indicate when.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=440951



Title: Re: Increase in seizures
Post by: dennis100 on November 25, 2011, 02:40:11 AM
Model Number 101
Event Date 01/01/2002
Event Type Injury Patient Outcome Life Threatening; Required Intervention
Event Description
Patient experienced a substantial increase in seizures following parameter reduction and was no longer able to control their seizures with use of the magnet. Additional programming changes were made and the patient is reportedly doing well since then.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=438628


Title: Re: Increase in seizures
Post by: dennis100 on November 25, 2011, 02:41:15 AM
Model Number 101
Event Date 12/12/2002
Event Type Injury Patient Outcome Life Threatening; Required Intervention
Event Description
Patient began gagging in 2002 and a few days later, the patient experienced six drop attacks (seizures that they had not had for quite a while). The patient reportedly continues to have staring spells about 4-5 times per day. Neck x-ray did not reveal any discontinuities in the ncp system and confirmed proper lead electrode placement. Physician added zonegran (200mg b. I. D. ) to patient's drug regimen and plans to see the patient again in six weeks for follow-up. Physician indicated that he does not know at this point what the cause of the patient's symptoms are. Recent device diagnostic testing was within normal limits, indicating that the ncp system was functioning properly. The patient's last parameter adjustment was in 2002 and there have been no changes in medication that could be contributing to the seizure increase. It was reported that the patient's overall health condition is not worsening at this time and that there were no enviromental stimuli that could have caused the increase in seizures.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=438644



Title: Re: Increase in seizures
Post by: dennis100 on November 25, 2011, 02:43:47 AM
Model Number 300-20
Event Date 10/01/2002
Event Type Malfunction
Patient Outcome Life Threatening; Hospitalization Required Intervention
Manufacturer Narrative
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. Dates are estimated. Only the month/year is known. Date of event.

Event Description
The pt's device reportedly stopped working in 2002 and the pt subsequently began to have an increase in seizures at that time. It is not known at this time whether the increase in seizures was above the pt's pre-vns baseline seizure frequency. The pt underwent generator replacement surgery for suspected end of service 2 months later. During the surgery, device diagnostic testing of the new generator with the original lead resulted in high lead impedance reading (dc-dc code 7 and limit), indicating possible device malfunction. Lead break was suspected by physician. The pt's incision site was closed with the decision to replace the lead at a later time. The pt's lead was replaced 2 weeks later. Visual inspection of the explanted lead by the o. R. Staff revealed a crack in the lead. It is not known at this time whether the lead was damaged during the generator explant procedure or whether a lead problem was in existence prior to the surgery.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=436446



Title: Re: Increase in seizures
Post by: dennis100 on November 25, 2011, 02:44:57 AM
Event Date 12/25/2002
Event Type Injury
Patient Outcome Hospitalization; Required Intervention
Event Description
Reporter indicated that patient's ncp system was programmed to on in 2002 and ever since then pt has experienced an increase in seizures. The patient was reportedly hospitalized for 3 days due to the increase in seizures. The patient was discharged from the hospital without any changes in medications or programmed parameters.

Manufacturer Narrative
Report is incomplete because no response has been received to numerous attempts to obtain additional information from initial reporter, neurologist and surgeon.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=441945



Title: Re: Increase in seizures
Post by: dennis100 on November 25, 2011, 02:45:49 AM
Model Number 102
Event Date 09/01/2002
Event Type Injury Patient Outcome Life Threatening;
Manufacturer Narrative
Report is incomplete because attempts to obtain additional information from physician have been unsuccessful to date. H6 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 since vns implant, the patient's seizures have increased in duration and intensity. Investigation to date has been unable to determine the severity of the seizure increase.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=438633


Title: Re: Increase in seizures
Post by: dennis100 on November 25, 2011, 02:46:56 AM
Model Number 101
Event Date 03/01/2002
Event Type Injury Patient Outcome Life Threatening; Hospitalization
Manufacturer Narrative
Dates are estimated. Only the month/year is known: date of event.

Event Description
Patient experienced an increase in seizures in 2002. The patient underwent generator replacement surgery 8 months later for end of service. It was reported that during the 7 days prior to the replacement surgery, the patient only had 2-3 nocturnal generalized tonic/clonic seizures and was controlled during the day. After programming the replacement generator to on the patient had constant absence and an average of 2 tonic/clonic seizures per night. Further follow-up revealed that the patient was hospitalized twice in the following month totaling 5 days due to episodes of status epilepticus.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=436049



Title: Re: Increase in seizures
Post by: dennis100 on November 25, 2011, 02:47:53 AM
Event Date 01/01/2002
Event Type Injury
Patient Outcome Life Threatening;
Manufacturer Narrative
Further follow-up revealed that the pt was seen by the physician on 02/11/2003 where it was reported that the urinary retention had resolved. The pt's mother wanted to have the pt's device settings increased at this visit; however, the physician decided to wait a while before increasing the settings. The pt has an appointment to follow-up with the physician in april 2003.

Event Description
Pt developed an eye tic when their programmed output current was increased from 0. 25ma to 0. 50ma. The magnet was used to temporarily stop stimulation and the symptom reportedly resolved. The pt is not on any anti-epileptic medications. The pt is also reportedly suffering from panic attacks, urine retention, inability to fight infections and a severe increase in seizures. Physician plans to continue to gradually increase device programmed output current.

Manufacturer Narrative
Report is incomplete due to anonymous nature of reported event.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=436093


Title: Re: Increase in seizures
Post by: dennis100 on November 25, 2011, 10:41:40 PM
Model Number 101
 Event Date 12/12/2002
Event Type Injury Patient Outcome Life Threatening; Required Intervention
Event Description
Patient began gagging in 2002 and a few days later, the patient experienced six drop attacks (seizures that they had not had for quite a while). The patient reportedly continues to have staring spells about 4-5 times per day. Neck x-ray did not reveal any discontinuities in the ncp system and confirmed proper lead electrode placement. Physician added zonegran (200mg b. I. D. ) to patient's drug regimen and plans to see the patient again in six weeks for follow-up. Physician indicated that he does not know at this point what the cause of the patient's symptoms are. Recent device diagnostic testing was within normal limits, indicating that the ncp system was functioning properly. The patient's last parameter adjustment was in 2002 and there have been no changes in medication that could be contributing to the seizure increase. It was reported that the patient's overall health condition is not worsening at this time and that there were no enviromental stimuli that could have caused the increase in seizures

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=438644





Title: Re: Increase in seizures
Post by: dennis100 on November 25, 2011, 10:43:27 PM
Event Date 12/01/2002
Event Type Injury Patient Outcome Life Threatening; Hospitalization
Manufacturer Narrative
Report is incomplete because attempts to obtain additional information were unsuccessful. Physician indicated that they felt that it was ridiculous that the manufacturer was requesting additional information because the patient made a claim and didn't know what patient was talking about. Physician indicated that they think it's unbelievable that the manufacturer puts this much weight into the patient complaints. Physician indicated that the fact that the manufacturer is required by fda regulations to follow-up patient complaints is preposterous and a waste of time.

Event Description
Patient was hospitalized for 10 days due to an increase in seizure activity. It was reported that prior to the hospitalization, the patient's programmed parameters were set to very low settings. It was also reported that during the patient's hospital stay, the patient's device was programmed to off so that they could undergo an mri. Reporter indicated that after the patient's device was programmed back to on, the patient experienced a shocking feeling from the device. The patient had reportedly been seizure-free for approximately one week at the time of the initial report with the device programmed to very low settings. Further follow-up with physician revealed that there are no longer any problems that the patient is experiencing. It was reported that the shocking feeling must have stopped because that patient would not have been discharged otherwise. Physician indicated that they did not see any problem with the patient or their device and that the patient's complaint was without substance. Physician indicated that the patient's device was disabled approximately 4 years ago (normal mode output current programmed to off) and that only device magnet output current remained active. The increase in seizures reportedly began last year at which time the normal mode output current was reactivated. Physician indicated that the patient complained about a shocking feeling at one point, but the tests were performed that showed that everything was fine and the patient has not complained since. Physician also indicated that the patient's original device had been replaced but did not indicate when.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=440951



Title: Re: Increase in seizures
Post by: dennis100 on November 25, 2011, 10:44:35 PM
Model Number 100
Model Number 302-20
Event Date 12/01/2002
Event Type Injury Patient Outcome Life Threatening; Required Intervention
Manufacturer Narrative
Further follow-up revealed that the pt has not returned the physician's office calls or come in for any appointments. The pt was last seen on 01/2003 by the physician. Physician's notes from this office visit revealed that both of the pt's incisions appeared to be healed and there are no further scare bubbles and no fluid around the left axilla. The pt had completed cipro 500mg every 12 hours for 15 days two to three days prior to the appointment in 01/2003.

Manufacturer Narrative
H. 6. Method: device mfg records were reviewed. Result: review of mfg records for both the pulse generator and the bipolar lead confirmed sterilization of devices. Ncp system labeling lists device (generator and/or lead) migration or extrusion and infection as a potential adverse events possibly associated with surgery or stimulation.

Event Description
Reporter indicated that pt's lead was protruding from the neck incision site, but had not yet broken through the skin. It was also reported that the pt had an infection and was prescribed antibiotics. Further follow-up revealed the pt reports continued serosanguinous drainage from neck incision in small amounts. Neurologist has not proceeded with programming of the device to on due to the infection. The pt has had recent increase in seizure activity with a fall during which pt sustained a jaw injury and dental fractures. Weight decline is reported secondary to the dental problems.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=440507


Title: Re: Increase in seizures
Post by: dennis100 on November 25, 2011, 10:45:29 PM
Model Number 101
Event Date 01/01/2003
Event Type Injury Patient Outcome Life Threatening;
Manufacturer Narrative
Report is incomplete because attempt to obtain additional information from physician has been unsuccessful to date.

Event Description
Patient had vns therapy for many years (first implant was in 1999) and has great success. However, lately patient has experienced an increase in seizures

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=448638


Title: Re: Increase in seizures
Post by: dennis100 on November 25, 2011, 10:46:50 PM
Model Number 102
Event Date 01/08/2003
Event Type Injury Patient Outcome Life Threatening; Required Intervention
Manufacturer Narrative
H. 6 ncp system labeling lists insomnia as a potential adverse event possibly associated with surgery or stimulation.
Event Description
The pt has been experiencing absence seizures immediately after having the vns programmed to on and also started having generalized seizures once a week. This is an increase in seizure activity from their baseline. Additionally, it was reported that the pt has had sleep distrubances and memory loss after having the vns programmed on. Initial device settings were 0. 5ma output current, 30 seconds on, 5 minutes off. At next office visit, the off time was decreased from 5 minutes off to 3 minutes off. At second office visit, the pt's device was programmed to off and their symptoms reportedly resolved immediately. Physician planned to reprogram device back to on at next office visit and monitor the pt's condition.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=446828




Title: Re: Increase in seizures
Post by: dennis100 on November 26, 2011, 10:54:25 AM
Event Date 06/03/2003
Event Type Injury Patient Outcome Life Threatening; Required Intervention
Manufacturer Narrative
Report is incomplete because attempts to obtain additional info have been unsuccessful to date. Initial reporter has not updated mfr on pt's current condition as requested. Foreign distributor has been unsuccessful to date in obtaining additional info from implanting hospital.

Event Description
Reporter indicated that vns patient experienced as many seizures in a 2. 5 hour airline flight as they have in a two-month period. It was reported that prior to boarding the flight, the pt was not allowed to pass through the airport metal detectors in their wheelchair. Airport security personnel reportedly passed a metal-detecting wand over the pt for a long period of time. This was reportedly performed right next to the walk-through metal detector. It was reported that the pt appeared to be fine just prior to boarding the plane, but that the pt seemed more tired than normal. The pt was very loud and vocal on the first leg of their trip with no seizing. After changing planes, the pt began to have continuous grand mal seizures and twitching. Ativan was administered but the seizures did not stop. The pt's family member did not seek medical attention once the plane landed because ". Lips were not blue, the pt was just seizing". The seizures reportedly stopped after the flight, but the pt continued to cry for the remainder of the day. It was reported that the pt was doing better two days later and that the pt's family member intended to take the pt to a local amusement park that day. It was reported that the pt has flown many times before and that this has never happened.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=468540




Title: Re: Increase in seizures
Post by: dennis100 on November 26, 2011, 10:55:03 AM
Model Number 101
Event Date 06/03/2003
Event Type Injury
Patient Outcome Life Threatening; Required Intervention
Manufacturer Narrative
H. 6. Vns therapy labeling states that the safety and efficacy of this therapy have not been systematically established for uses not covered in the "intended use / indications" section of the manual or in patients with history of previous therapeutic brain surgery.

Event Description
Reporter indicated that pt had 5 grand mal seizures in one night. It was reported that the pt's alertness had improved greatly since generator replacement surgery two years ago, but that pt had recently started having night-time seizures. The pt's neurologist was scheduled to check their dilantin level, but the pt started to stagger four days prior to scheduled appointment so their family member discontinued pt's dilantin. The pt reportedly got worse after that, so their family member gave pt diastat the next day. Two days later, the pt reportedly had 5 grand mal seizures. The pt's personality has reportedly changed and pt looks and walks differently. A caregiver had moved in with the pt just before the above mentioned incidents occurred. Further follow-up revealed that the pt's condition is much improved since office visit with parameter adjustment. The pt is still having seizures, but is back to their baseline seizure frequency. Treating neurologist indicated that the pt's seizure types had not changed and that the pt's overall health condition was not worsening. There were reportedly no medication changes or environmental stimuli that could have caused the pt's increase in seizures.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=468556



Title: Re: Increase in seizures
Post by: dennis100 on November 26, 2011, 10:55:58 AM
Model Number 101
Event Date 06/18/2003
Event Type Injury Patient Outcome Disability; Required Intervention
Event Description
Pt had a vagal nerve stimulator implanted. In 2002 for intractable epilepsy. Pt was doing well on rapid cycling mode, then at some point in the past 2 months the device reverted to baseline settings, and the pt's seizures have increased. When interrogated, the vns battery was fine and the device was programmed back to previous settings. The only recent occurrence was in 2003 when the school apparently used the pt's magnet multiple times in a 2 hour period.

Event Description
Add'l info rec'd from mfr 8/7/03: follow-up revealed that since the generator was reporgrammed back to the previous settings following the event, the pt is "doing much better". When the co asked whether or not an interrupted lead test may have occurred during the pt's prior office visit, the reporter could not recall if this happened. If a lead test is interrupted, the programmed settings will revert to nominal settings (1. 0ma). This interruption can occur when the programming wand is moved during a programming session. Cyberonics recommends that the device be interrogated after reprogramming to assure that the device is programmed appropriately. Device programming history was requested but not received. The reporter would not provide any pt info; therefore, co was unable to identify the implanted device and adequately complete the medwatch form.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=467651



Title: Re: Increase in seizures
Post by: dennis100 on November 26, 2011, 11:08:46 AM
Model Number 102
Event Date 10/01/2003
Event Type Injury Patient Outcome Life Threatening; Hospitalization
Event Description
Pt's seizures had increased from pre-vns seizure rate following an increase in device output current from 0. 75ma to 1. 0ma. Further follow-up revealed that treating neurologist did not believe that the increase in seizures was above the pt's pre-vns baseline frequency. It was reported that the pt first complained of a burning and choking sensation with stimulation after an increase in device output current from 0. 50ma to 0. 75ma. The burning became more intense when output current was increased to 1. 0ma and when the pt uses their magnet (1. 25ma output current) to initiate magnet mode stimulation. The pt has reportedly required immediate attention due to a severe seizure during which they experienced several hematomas and bruising.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=499989




Title: Re: Increase in seizures
Post by: dennis100 on November 26, 2011, 11:09:20 AM
Event Type Malfunction
Event Description
Reporter indicated that vns pt has been experiencing a possible generator malfunction. It was reported that the pt is experiencing erratic stimulation and an increase in seizures the pt is also experiencing pain from the stimulation. Reporter indicated that the pt is now using the magnet to inactivate the generator.

Manufacturer Narrative
Report is incomplete because attempts to obtain additional info have been unsuccessful to date.

 
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=465341



Title: Re: Increase in seizures
Post by: dennis100 on November 26, 2011, 11:09:46 AM
Model Number 101
Event Date 05/01/2003
Event Type Injury Patient Outcome Life Threatening; Hospitalization
Event Description
Reporter indicated that pt was hospitalized due to tonic-clonic seizures, a seizure type that pt did not have prior to vns implant. The vns therapy has reportedly provided seizure control for the pt's other seizure types. Further follow-up with treating neurologist revealed that pt's generalized motor seizures have recurred since vns implant and that pt is currently experiencing both complex partial and generalized motor seizure types. The pt's pre-vns seizure type (complex partial) has been much better controlled with the vns therapy. There have been no medication changes or environmental stimuli that could be contributing to the recurrence of the generalized motor seizures. It was reported that the pt's overall health condition is not worsening and that there have been no recent changes in device settings. The pt is reportedly in stable condition folowing release from the hospital with no further generalized motor seizures to date. Neurologist indicated that he believed that the ncp system was related to the reported event.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=464317


Title: Re: Increase in seizures
Post by: dennis100 on November 26, 2011, 11:10:22 AM
Model Number 102
Event Date 02/12/2003
Event Type Injury Patient Outcome Life Threatening;
Manufacturer Narrative
Report is incomplete because attempts to obtain additional info have been unsuccessful to date. No response has been received to manufacturer's requests for additional info from treating neurologist. H. 6. The vns therapy system is indicated for use as an adjunctive therapy in reducing the frequency of seizures in adults and adolescents over 12 years of age with partial onset seizures that are refractory to antiepileptic medications. In the united states, the vns therapy is approved for use in adults and adolescents over 12 years of age with partial onset seizures that are refractory to antiepileptic medications.

Event Description
Reporter indicated that vns pt's seizures have gotten worse since implant. It was reported that the pt is regressing and is more rigid. The pt reportedly stays rigid for approximately 5 seconds and now cries after their seizures. The pt is scheduled for follow-up with neurologist at which time medication changes will be considered.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=464360



Title: Re: Increase in seizures
Post by: dennis100 on November 26, 2011, 11:10:53 AM
Model Number 102
Event Date 04/01/2003
Event Type Injury Patient Outcome Life Threatening; Hospitalization Required Intervention
Event Description
Vns pt has been experiencing more seizures since stimulation was initiated. It was reported that the pt normally has seizures at night, but now the pt has seizures both at night and during the day. The pt's seizures are now longer lasting than normal and they reportedly affect pt worse. It was reported that the pt has fallen twice and had to get stitches. Reporter indicated that the pt seems to be more sleepy than usual because of the increase in seizures. Pt's family member plans to tape the magnet over the device to stop stimulation while the pt is sleeping and follow-up with neurologist. Pt's neurologist indicated that the pt's seizure types have not changed from general tonic clonic seizure history. It was reported that there have been no medication changes or environmental stimuli that may have contributed to the seizure increase, although the pt did have a cold. The pt's condition is reportedly not worsening and there have been no adjustments to device settings recently.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=464748


Title: Re: Increase in seizures
Post by: dennis100 on November 26, 2011, 11:11:33 AM
Model Number 101
Event Date 11/05/2003
Event Type Injury Patient Outcome Hospitalization;
Manufacturer Narrative
Report is incomplete because no response has been received to manufacturer's requests for additional information from treating neurologist.

Event Description
Reporter indicated that vns patient was seen in hospital emergency room due to an increase in seizure activity. It was reporte
d that it was an increase from efficacy received with the vns therapy, and not an increase above patient's pre-vns baseline seizure frequency. Device diagnostic testing was within normal limits, indicating proper device function. The elective replacement indicator was no, indicating that the generator had not reached end of service. Treating neurologist decreased programmed device pulse width and off time.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=499370





Title: Re: Increase in seizures
Post by: dennis100 on November 26, 2011, 11:12:54 AM
Model Number 101
Event Date 05/01/2003
Event Type Injury Patient Outcome Life Threatening;
Manufacturer Narrative
Report is incomplete because attempts to obtain additional info have been unsuccessful to date. No response has been received to manufacturer's requests for additional info from treating neurologists.

Event Description
Reporter indicated that vns pt has recently experienced six grand-mal seizures. It was reported that the treating neurologist would not adjust the pt's device settings. It was reported that the pt also has a lump on the back of the head. When having one of the seizures she stopped breathing for a short period of time. It was reported that since the pt went without oxygen for so long, the pt's memory has been "wiped out", and the pt is unable to do the basic skills finding things. Investigation to date has been unable to determine whether or not the recent seizure episodes are above the pt's pre-vns baseline seizure frequency and whether or not the events are related to the ncp system.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=463199



Title: Re: Increase in seizures
Post by: dennis100 on November 26, 2011, 11:14:07 AM
Model Number 100
Event Date 01/01/1999
Event Type Injury Patient Outcome Life Threatening; Required Intervention
Event Description
The pt's device had been programmed to off. It was reported that the pt's seizures worsened in duration, intensity and frequency with the vns therapy. The pt received the vns therapy for one year at the advice of the pt's physician until such time that the pt's family member demanded that the device be programmed to off. Treating neurologist indicated that the pt's seizure increase was not an increase above pre-vns baseline and that the family was too anxious with the device. Treating neurologist indicated that the ncp system was not related to the reported event.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=501727




Title: Re: Increase in seizures
Post by: dennis100 on November 26, 2011, 11:14:52 AM
Model Number 300-20
Event Date 05/01/2003
Event Type Malfunction
Patient Outcome Life Threatening;
Manufacturer Narrative
H. 6. Method: device manufacturing records were reveiewed. H. 6. Results: review of manufacturing records for both the pulse generator and the bipolar lead revealed no anomalies that would adversly effect device performance.

Event Description
Reporter indicated that vns patient had been seizure-free with the vns therapy until they recently experienced a grand mal seizure. It was reported that approximately three weeks before the grand mal sizure, the patient was experincing erratc stimulation and the approximately on week prior to the grand mal seizure, stimulation caused the pateint's neck (at the area of the neck incision site) to "bulge out in a knot". The patient has also indicated that sometimes they cannot feel the normal mode or magnet mode stimulation. The patient was seen by neurologist after having the grand mal seizure, at which time the device output current was increased to maximum setting (3. 5ma). The patient still did not feel stimulation. The neurologist indicated that the generator was functioning properly and that he suspected that something was wrong with the lead. The patient was referred to neurosurgeon. Review of x-rays by neurosurgeon did not reveal any obvious discontinuities in the ncp system. The neurosurgeon does not want to perform exploratory surgery as he is uncomfortable exploring the lead. It was reported that the patient's device had been programmed to rapid cycling, but the device diagnostic testing resulted in elective replacement indicator "no", indicating that the generator was not at end of service.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=463973



Title: Re: Increase in seizures
Post by: dennis100 on November 26, 2011, 11:16:49 AM
Model Number 102
Event Date 08/01/2003
Event Type Injury Patient Outcome Life Threatening; Required Intervention
Event Description
Reporter indicated that pt had experienced drop seizures which pt never had before vns implant. It was reported that treating neurologist increased device pulse width and decreased normal mode output current as well as increased the pt's medications (klonopin and zonegran). The pt's overall health condition is not worsening and there were reportedly no environmental stimuli that could have caused the change in seizure type. There had reportedly been no recent changes in device settings prior to the change in seizure type. Device diagnostic testing was within normal limits, indicating proper device function. The pt is reportedly seizure-free following parameter and medication adjustments.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=485986


Title: Re: Increase in seizures
Post by: dennis100 on November 26, 2011, 11:17:31 AM
Model Number 101 
Event Date 08/01/2003
Event Type Injury Patient Outcome Life Threatening; Hospitalization Required Intervention
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
Patient's device was explanted because the patient experienced "quite a few breakthrough seizures". The patient had not been able to feel their stimulation as much as they used to. There had been no parameter adjustments for approximately four months at the time of the initial report. Device diagnostic testing at that time was within normal limits, indicating proper device function. It was believed that the patient had simply become accustomed to the stimulation. It was later reported that the patient's device was explanted as a "prophylactic replacement" due to "increased seizures".

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=484754




Title: Re: Increase in seizures
Post by: dennis100 on November 26, 2011, 11:18:11 AM
Model Number 102
Event Date 07/01/2003
Event Type Injury Patient Outcome Life Threatening; Hospitalization
Event Description
Pt seems to be having more seizures than before they were implanted with the vns. Reporter wasn't sure whether caretakers at the nursing home were just paying more attention to the pt since vns implant or not. It was reported that the pt had a seizure that lasted 30 minutes resulting in an emergency room visit. Nursing home also indicated that the magnet did not work. The pt's family member indicated that when the pt was home with them, the magnet was used and did work. Further follow-up with treating neurologist revealed that the pt experienced 2-3 drop attacks per day pre-vns implant and that they now have 5-6 drop attacks per day. The pt's seizure types have reportedly not changed. The pt's overall health condition is not worsening. Treating neurologist was not sure whether there were any evironmental stimuli or current changes in medication regimen that may be contributing to the seizure increase. Neurologist indicated that the seizure increase was not related to the vns.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=483171


Title: Re: Increase in seizures
Post by: dennis100 on November 26, 2011, 11:19:05 AM
Model Number 300-20
Event Type Malfunction
Event Description
Reporter indicated that vns pt was scheduled for vns therapy system replacement surgery because both the neurologist and the neurosurgeon believed that there was a bad connection with the pt's current system as the pt was having an increase in seizures. Further follow up revealed that revision surgery was performed and the pt's lead was replaced. The generator was reportedly functioning properly. No generator/lead connection problem was noted during the revision surgery, but it was reported that there was a problem with the lead and that the lead needed to be replaced. Investigation to date has been unable to determine the nature of the led problem. The pt is reportedly doing well after the revision surgery. The pt's ant-epileptic medications were increased when pt began to experience the increase in seizures. The pt's seizures are well controlled following lead replacement surgery and pt's medications have been decreased back to the usual dosages.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=483628



Title: Re: Increase in seizures
Post by: dennis100 on November 26, 2011, 11:20:19 AM
Model Number 102
Event Date 06/01/2003
Event Type Injury Patient Outcome Life Threatening;
Manufacturer Narrative
Report is incomplete because treating neurologist indicated that they will not respond to manufacturer's requests for additional information until after they see the patient again for follow up.

Event Description
Reporter indicated that vns patient has experienced an increase in seizure frequency since vns implant. It was reported that the patient had seizures every 4-6 weeks pre-vns, but that since vns implant the patient has seizures every two weeks. The seizures have reportedly decreased in duration and now has auras which patient did not have pre-vns. It was reported that there have been some recent stressful events in the patient's life that may be contributing to the seizure increase and the patient has been more depressed.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=482394



Title: Re: Increase in seizures
Post by: dennis100 on November 26, 2011, 11:21:09 AM
Model Number 101
Event Date 07/01/2003
Event Type Injury Patient Outcome Life Threatening; Required Intervention
Manufacturer Narrative
The following dates are estimated. Only the month/year is known: b. 3, date of event.

Event Description
Reporter indicated that vns pt has experienced an increase in seizures. Treating neurologist indicated that the increase in seizures was above the pt's pre-vns baseline frequency. Device diagnostic testing was within normal limits, indicating proper device function. Elective replacement indicator was no, indicating that the generator has not reached end of service. It was reported that the pt's seizure frequency increase began with a change in their living situation. Treating neurologist indicated that he believes that the the pt's generator may be nearing end of service. Parameter adjustments were made in an effort to conserve generator battery life. The pt's condition was reported as "poor" with frequent seizures

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=482021



Title: Re: Increase in seizures
Post by: dennis100 on November 26, 2011, 11:22:00 AM
Model Number 101
Event Date 07/01/2003
Event Type Injury Patient Outcome Hospitalization; Life Threatening Required Intervention
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 over 12 years of age 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 over 12 years of age with partial onset seizures that are refractory to antiepileptic medications.

Event Description
Reporter indicated the vns patient was hospitalized for three days due to an episode of status. It was reported that the patient's device had been programmed to rapid cycling and that parameter adjustments were made during the patient's hospital stay. The patient's device is reportedly no longer set to rapid cycling parameters. Treating neurologist is planning to perform a 24-hour eeg and a pet scan and it was reported that the patient may also need a mri to check tumor growth. Further follow-up revealed that the patient's device had been programmed to rapid cycling parameters (activating approximately every 12 seconds) just prior to the status episode. Treating neurologist reportedly believes that the rapid cycling may have been cause of the status episode. Treating neurologist indicated that the patient was seen in the hospital emergency room at which time device parameters were reduced and the patient was sent home an hour later.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=482281



Title: Re: Increase in seizures
Post by: dennis100 on November 26, 2011, 11:23:09 AM
Model Number 101
Event Date 01/01/2002
Event Type Injury Patient Outcome Life Threatening; Hospitalization Required Intervention
Manufacturer Narrative
Report is incomplete because no response has been received to manufacturer's request for additional information from treating neurologist.

Event Description
Patient has been having episodes of jerking and shutting eyes that last for about 40 minutes. It was reported that the patient has a history of seizures, he falls backwards and eyes roll up, but the jerking and eye-shutting is new since vns implant. The patient reportedly had two of these episodes recently. It was reported that the last episode of this nature was last year when they ended up in the hospital emergency room and was kept asleep with another medication for three hours. The patient reportedly grabs head during these episodes and left three fingers go number on this left hand and it spreads up to neck. The patient was sent by neurologist recently and reported these episodes, but the neurologist did not seem too concerned about them. Swiping the device with the magnet during these episodes does not relieve the patient's symptoms, although magnet swipes do successfully interrupt other seizure activity for the patient.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=502185


Title: Re: Increase in seizures
Post by: dennis100 on November 26, 2011, 11:24:13 AM
Model Number 101
Event Date 01/01/2002
Event Type Injury Patient Outcome Life Threatening; Required Intervention
Manufacturer Narrative
Report is complete because no response has been recieved to manufacturer's requests for additional information from treating neurologist. H. 6. Ncp system labeling lists dyspnea as a potential adverse event possibly associated with surgery or stimulation. H. 6 ncp system labeling cautions that patients with obstructive sleep apnea (osa) may have increased apneic events during stimulation. Cyberonics recommends care when treating patient's with preexisting osa. Lowering stimulus frequency or prolonging off time may prevent exacerbation of osa.

Event Description
Vns patient's device was programmed to "off" due to a increase in seizures. It was reported that the device was programmed to off after the patient began to experience a "flurry" of seizures. The patient was fine after the device was programmed to "off", but has recently started to have an increase in seizures. Treating neurologist reportedly an mri and possibly programming the device back to "on". It was also reported that the patient was diagnosed with sleep apena and that had trouble breathing when first implanted. Treating neurologist reportedly believed that it was due to vns and subsequently programmed the device to "off". The patient currently uses a bipap machine that helps apnea.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=502171



Title: Re: Increase in seizures
Post by: dennis100 on November 26, 2011, 11:25:38 AM
Model Number 102
Event Date 10/01/2003
Event Type Injury Patient Outcome Life Threatening; Required Intervention
Event Description
Reporter indicated that vns patient's device was programmed to off due to an increase in seizures above pre-vns baseline frequency. Further follow-up revealed that the patient experienced 8 to 10 myoclonic and tonic seizures per week pre-vns and has reportedly experienced 2 to 7 seizures per day since the increase. Treating neurologist indicated that the patient felt as if the increase in seizures was caused by the vns. The patient's seizure types have not changed. Neurologist plans follow up as required and has no plans to program the device back to on at this time. The patient was a "no-show" at their next scheduled appointment following deactivation of device. It was reported that the patient's seizure types had not changed and that the patient's overall health condition was not worsening. There had reportedly been no recent medication changes or changes to programmed device parameters. Treating neurologist did not know whether there were any evironmental stimuli that may have contributed to the seizure increase. Device diagnostic testing was within normal limits, indicating proper device function. The elective replacement indicator was no, indicating the generator has not reached end of service.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=504027



Title: Re: Increase in seizures
Post by: dennis100 on November 26, 2011, 11:30:21 AM
Model Number 102
Event Date 11/01/2003
Event Type Injury Patient Outcome Life Threatening; Required Intervention
Manufacturer Narrative
H6. 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 abolescents with partial onset seizures that are refractory to antepileptic medications. Vns therapy system labeling cautions that pts with obstructive sleep apnea (osa) may have increased apneic events during stimulation. Cyberonics recommends care when treating pts with preexisting osa. Lowering stimulus frequency or prolonging off time may prevent exacerbation of osa.

Event Description
Reporter indicated that vns pt experienced an increase in seizures and abnormal breathing at night since an increase in programmed parameters approximately two weeks prior. It was reported that the increase in seizures was not above pre-vns baseline frequency and could possibly be attributed to a cold that the pt had a few weeks ago. The pt reportedly has difficulty breathing and stops breathing for short periods. The pt's family member, who is a physician, used a pulse oximeter on the pt at night and noted that their oxygen saturation fell from 97% to 90% and their heart rate increased from 82 beats per minute to 92 beats per minute. Treating neurologist indicated that the pt experienced an increase in lethargy and an increase in seizures, especially at night. It was reported that the pt experienced stridor during sleep with stimulation and that their oxygen saturation was 90% during these episodes. It was reported that the pt's overall health condition was worsening and that the pt was experiencing sleep apnea. Device diagnostic testing was within normal limits, indicating proper device function. Further follow-up revealed that the pt's condition had improved after a reduction in programmed device settings and changes to their drug regimen. The pt has experienced no further episodes of stridor and their seizure episodes have decreased.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=503250



Title: Re: Increase in seizures
Post by: dennis100 on November 26, 2011, 11:31:46 AM
Model Number 102
Event Date 01/01/2003
Event Type Injury Patient Outcome Life Threatening;
Manufacturer Narrative
Report is incomplete because no response has been received to mfr's request for add'l info from treating neurologist.

Event Description
Reporter indicated that vns patient has experienced an increase in seizures. The patient has reportedly never received efficacy from the vns therapy. Additionally, the patient has c3, c4, c5 and c6 herniated disks and feels as though the pain in their neck that patient was having with these herniated disks has worsened since vns implant. It was reported that pre-vns, physical therapy would help the pain and that since implant, the patient has had to begin taking extended release morphine and norflex. The pain is continuous and does not coincide with stimulation. Temporarily discontinuing stimulation with the magnet had no effect on the pain. The pain is described as "hot searing pain from the neck down to left arm. " investigation to date has been unable to determine whether the seizure increase is above pre-vns baseline frequency.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=503296



Title: Re: Increase in seizures
Post by: dennis100 on November 26, 2011, 11:32:45 AM
Model Number 101
Event Date 05/16/2003
Event Type Injury Patient Outcome Life Threatening; Required Intervention
Manufacturer Narrative
Report is incomplete because initial reporter asked mfr not to contact treating neurologist.

Event Description
Reporter indicated that pt has experienced an increase in grand mal seizures since vns implant. It was reported that pre-vns, the pt averaged 2-3 grand mal seizures per month. Post-vns implant, the pt reportedly experiences 5-6 grand mal seizures per month. The pt reportedly experiences daily small seizures, but these have not changed in frequency or intensity. Adjustments to device settings have not resolved the increase in grand mal seizures. Medication dosages were recently increased. The pt's family member indicated that they would like to have the device explanted.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=503329



Title: Re: Increase in seizures
Post by: dennis100 on November 26, 2011, 11:33:28 AM
Model Number 302-20
Event Date 09/24/2003
Event Type Injury Patient Outcome Life Threatening; Disability
Manufacturer Narrative
H. 6: vns therapy system labeling lists voice alteration (hoarseness) as a potential adverse event possibly associated with surgery or stimulation.

Event Description
Reporter indicated that vns patient has been experiencing hoarseness and frequent absence seizures since lead replacement surgery. The patient has also complained of intolerance to cold since lead replacement surgery.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=501918



Title: Re: Increase in seizures
Post by: dennis100 on November 26, 2011, 11:35:50 AM
Model Number 102
Event Date 10/01/2003
Event Type Injury Patient Outcome Life Threatening; Required Intervention
Manufacturer Narrative
Report is incomplete because no response has been received to manufacturer's request 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 effect device performance.

Event Description
Vns patient experienced an increase in seizures following parameter adjustment. It was reported that device pulse width was reduced from 500 msec to 250 msec because the patient was "getting shocked" when using cordless phone. It is believed that there may be a magnet in the cordless phone that the patient was using. A few days after the parameter adjustment, the patient experienced an increase in seizures with loss of consciousness like pre-vns. It was reported that there had been no injury or trauma that may have damaged the vns therapy system. Review of x-rays by neurosurgeon did not reveal any discontinuities in the vns therapy system. Further follow-up revealed that the patient was seen by neurologist after the increase in seizures and additional parameter adjustments were made. Patient condition following parameter adjustment is not known.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=502481



Title: Re: Increase in seizures
Post by: dennis100 on November 26, 2011, 11:36:31 AM
Model Number 101 
Event Date 08/01/2003
Event Type Injury Patient Outcome Life Threatening; Hospitalization Required Intervention
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
Patient's device was explanted because the patient experienced "quite a few breakthrough seizures". The patient had not been able to feel their stimulation as much as they used to. There had been no parameter adjustments for approximately four months at the time of the initial report. Device diagnostic testing at that time was within normal limits, indicating proper device function. It was believed that the patient had simply become accustomed to the stimulation. It was later reported that the patient's device was explanted as a "prophylactic replacement" due to "increased seizures".

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=484754




Title: Re: Increase in seizures
Post by: dennis100 on November 26, 2011, 11:37:12 AM
Model Number 101
Event Date 01/01/2003
Event Type Injury Patient Outcome Life Threatening; Required Intervention
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. The vns therapy system is approved for use in adults and adolescents over 12 years of age with partial onset seizures that are refractory to antiepileptic medications. Ncp system labeling cautions that pts with obstructive sleep apnea (osa) may have increased apneic events during stimulation. Cyberonics recommends care when treating pts with preexisting osa. Lowering stimulus frequency or prolonging off time may prevent exacerbation of osa.

Event Description
Vns pt experienced an increase in seizures following an increase in programmed output current from 1. 25ma to 1. 50ma. It was reported that the pt began having cluster seizures following the parameter increase. The pt was seen by a different neurologist who decreased programmed output current from 1. 50ma back down to 1. 25ma and the pt is reportedly seizure-free once again. Investigation to date has been unable to determine whether the seizure increase was an increase above the pt's pre-vns baseline frequency or simply an increase from previous efficacy with the vns therapy.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=500256



Title: Re: Increase in seizures
Post by: dennis100 on November 26, 2011, 11:38:14 AM
Model Number 102
Event Date 01/01/2003
Event Type Injury Patient Outcome Life Threatening; Hospitalization Required Intervention
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 over 12 years of age 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 over 12 years of age with partial onset seizures that are refractory to antiepileptic medications. Additionally, vns therapy system labeling states that the safety and efficacy of this therapy have not been systematically established for use in pts with neurological diseases other than epilepsy.

Event Description
Vns pt has been experiencing constant seizures. The pt reportedly has seizures all day and all night until they finally have a grand mal seizure after which they sleep for hours. This cycle of seizure activity reportedly starts again the following day in the same pattern. Further follow-up revealed that the pt's device was programmed off for a day while they were hospitalized for the constant seizures. When the device was programmed back to on, parameters were not set to rapid cycling as they were previously programmed to and new medications were added to their drug regimen. The pt was discharged to home but still has a problem getting their seizures under control.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=502768



Title: Re: Increase in seizures
Post by: dennis100 on November 26, 2011, 11:39:21 AM
Model Number 302-20
Event Type Malfunction
Manufacturer Narrative
H. 6. Device manufacturing records were reviewed. X-rays were reviewed. Review of manufacturing records for both the pulse generator and the bipolar lead revealed no anomalies that would adversely effect device performance. Review of x-rays dated july 2002 showed no anomalies other than a less than adequate strain relief bend. Later x-rays dated november 2003 showed a tie-down much closer to the positive electrode than originally viewed, indicating that either the electrode migrated or the tie-down came loose from the fascia and slid down the lead body toward the bifurcation, resting finally on the thin bifurcated positive and negative lead wires. The latter x-ray also showed a sharp turn in the leadwire path near this tie-down. No obvious discontinuities were identified via x-ray.

Event Description
Reporter indicated that vns pt experienced an increase in seizures above previous efficacy with the vns therapy system. The seizure increase was not above pre-vns baseline frequency. It had previously been reported that device diagnostic testing of the pt's device resulted in high lead impedance reading which prompted the treating neurologist to order x-rays. Upon review of x-rays, neurologist first believed that the lead connector pin was slightly out of the generator header, but then later indicated that he may have been mistaken. No further action was planned at that time because the pt was receiving the therapy as programmed, had not experenced a loss of seizure control and could still feel stimulation. It was later reported that the pt began to experience an increase in seizures over a few months time. There had been no changes in device programming, diet, medications or habit that may have contributed to the seizure increase. Evoked potential monitoring did not conclusively confirm a lead discontinuity, but review of x-rays by manufacturer did show two areas of concern regarding lead integrity. The vns therapy system was replaced. During replacement surgery, surgeon noted that the lead anchor tether was off of the nerve. Tissue covered the area of bifurcation at the anchor tether, preventing visual inspection of lead integrity at that location at time of explant. Lead break is suspected.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=545160



Title: Re: Increase in seizures
Post by: dennis100 on November 26, 2011, 11:40:13 AM
Model Number 101
Event Date 01/01/2004
Event Type Malfunction
Event Description
Reporter indicated that patient has experienced an increase in seizures and no longer feels stimulation. Neurologist indicated that the patient has experienced daily seizures. Further follow-up revealed that the patient has been scheduled for re-implant consultation. It is unknown whether or not the increase in seizures is above the patient's pre-vns baseline.

Manufacturer Narrative
H. 6. Device manufacturing records were reviewed. H. 6. Review of manufacturing records for both the pulse generator and the bipolar lead revealed no anomalies that would adversely effect device performance.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=586417



Title: Re: Increase in seizures
Post by: dennis100 on November 26, 2011, 11:41:04 AM
Model Number 300-20
Event Date 02/01/2004
Event Type Malfunction
Manufacturer Narrative
The following dates are estimated. Only the month/year is known: b. 3, date of event.

Event Description
Device diagnostic testing at office visit resulted in high lead impedance reading, indicating possible device malfunction. The elective replacement indicator was no, indicating that the generator was not at end of svc. There was no known injury or trauma that may have damaged the ncp system, but it was reported that the pt had a seizure that lasted for 14 mins prior to the high impedance reading. Additionally, it was reported that the pt could no longer feel stimulation and that they have experienced an increase in seizure activity. Review of x-rays revealed that the negative lead connector pin did not appear to be fully inserted into the generator header. Ncp system replacement surgery is planned. Treating neurologist reportedly believes that fibrosis may be the cause of the high lead impedance test result due to the length of time that the lead has been in place.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=539044



Title: Re: Increase in seizures
Post by: dennis100 on November 26, 2011, 12:40:13 PM
I still have 9 more years worth of MAUDE to sift through. Expect approx 2000 increased seizure reports

Where the hell is the FDA??? Guess they don't really give a shit about epileptics and the severely depressed.

Birdbomb and i can't get this deadly device off the market by ourselves. We need your help.

The FDA's Dr. Shuren and Dr. Maisel are well aware of all the problems associated with the vns. I was told so by Mr. Maisel during our telephone conversation where he filled me up with all kinds of empty promises. His phone call came within a few days of an article critical of the FDA and Cyberonics in The British Medical Journal (with my story included).

I suggest you direct all of your complaints and horror stories to them. Maybe, just maybe they will get so sick and tired of hearing about the vns that they will actually start do their job.....Protecting the public against dangerous/deadly medical devices.

FYI-Dr. Maisel is the man with the final say-so on recalls.

 
OFFICE OF THE CENTER DIRECTOR
Main tel: 301-796-5900
Fax: 301-847-8510
Address: WO Bldg 66 Rm 5429
10903 New Hampshire Ave
Silver Spring, MD 20993


Center Director
Jeffrey Shuren, M.D., J.D.
301–796–5900
jeff.shuren@fda.hhs.gov

Deputy Center Director for Science and CDRH Chief Scientist
William Maisel, M.D., M.P.H.
301–796–5900
william.maisel@fda.hhs.gov


Title: Re: Increase in seizures
Post by: dennis100 on November 26, 2011, 12:51:01 PM
Model Number 102
Event Date 11/30/2010
Event Type Injury Patient Outcome Required Intervention;
Event Description
It was initially reported to the manufacturer that the pt is "having seizures everyday new. " device diagnostics at the time of the report were within normal limits and the device was not at an end of service condition. It was unk if the increased seizure level that the pt was experiencing was above or below pre-vns baseline measurements. The pt's settings were increased at that time. Later, the pt was referred for generator revision and was replaced, which has yet to be returned to date. Good faith attempts to obtain additional info have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1947555



Title: Re: Increase in seizures
Post by: dennis100 on November 26, 2011, 03:11:04 PM
Model Number 103
Event Date 09/01/2010
Event Type Injury Patient Outcome Required Intervention;
Manufacturer Narrative
Review of programming/device diagnostic history.

Event Description
It was reported that a pt began to experience an increase in seizure in (b)(6) 2010 and would be referred for generator revision surgery as the device was suspected to be nearing end of service. The nurse practitioner who treats the pt believed the end of service may be premature, however, based on the patient's settings; the end of service projection appeared to be accurate. A different physician adjusted the patient's settings in order to prolong battery life and the patient's parents indicated that the setting change could have contributed to the increase in seizure activity. A copy of the flashcard will be sent to the manufacturer for further analysis. The pt underwent generator revision surgery and the explanted generator has been returned to the manufacturer. Product analysis has not been completed at this time. Good faith attempts to obtain additional info are currently being made.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1943798



Title: Re: Increase in seizures
Post by: dennis100 on November 26, 2011, 11:31:48 PM
Event Date 01/01/2003
Event Type Injury Patient Outcome Life Threatening;
Manufacturer Narrative
Report is incomplete because device tracking information was not forwarded to manufacturer. Additionally, no response has been received to manufacturer's requests for additional information from treating neurologist. It was reported that the patient has not been seen by their neurologist for a while. H. 6. : the vns therapy system labeling lists choking sensation and dyspnea as potential adverse events possibly associated with surgery or stimulation.

Event Description
Reporter indicated that patient's seizures seem to be getting worse since vns implant. It was reported that the patient has been set to the lowest settings since implant and that when increases in programmed parameters are attempted, the patient feels "strangled" and has trouble breathing. The patient also reports headache pain that they believe is related to the vns. Investigation to date has been unable to determine whether the patient has experienced an increase in seizures above pre-vns baseline frequency.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=487259



Title: Re: Increase in seizures
Post by: dennis100 on November 26, 2011, 11:34:08 PM
Model Number 100
Event Date 01/01/2000
Event Type Injury Patient Outcome Life Threatening; Required Intervention
Event Description
In the process of contacting the patient's neurologist to notify him that the patient's device may be nearing end of service, it was discovered that the patient had experienced an increase in seizures over a one year period with the vns therapy. The patient had 160 seizures in the year prior to vns implant and 390 seizures in the year after vns implant. The patient's device was subsequently programmed to off approximately 15 months post-implant and was programmed back to on 20 months later. Various medication changes were made during this time. Treating neurologist is attempting to adjust device settings for favorable seizure control and continues medication changes. Device diagnostic testing was within normal limits, indicating proper device function. The elective replacement indicator was no, indicating that the generator had not reached end of service. It was reported that during the time of the increased seizures, the patient's post-ictal state was better and their appetite, sleep pattern and behavior were unchanged. Stimulation was gradually reduced over a period of one month prior to programming the device to off. It was reported that the patient had less frequent but more intense seizure without the vns therapy. It was also reported that during the time that the generator was programmed to off, the patient had several episodes of suddenly becoming unresponsive. There was a question of whether there was no heart rate or respiratory effort during these episodes, but by the time caregivers obtained a stethoscope, the patient was reportedly breathing and their heart rate had recovered. The patient was seen by a cardiologist who indicated that the patient was having syncope, but that since patient was a do not resusciate, no further workup was warranted. Caregivers are seeking second cardiac opinion.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=487256




Title: Re: Increase in seizures
Post by: dennis100 on November 26, 2011, 11:36:17 PM
Model Number 100 
Event Date 01/01/2000
Event Type Injury Patient Outcome Life Threatening; Required Intervention
Event Description
In the process of contacting the patient's neurologist to notify him that the patient's device may be nearing end of service, it was discovered that the patient had experienced an increase in seizures over a one year period with the vns therapy. The patient had 160 seizures in the year prior to vns implant and 390 seizures in the year after vns implant. The patient's device was subsequently programmed to off approximately 15 months post-implant and was programmed back to on 20 months later. Various medication changes were made during this time. Treating neurologist is attempting to adjust device settings for favorable seizure control and continues medication changes. Device diagnostic testing was within normal limits, indicating proper device function. The elective replacement indicator was no, indicating that the generator had not reached end of service. It was reported that during the time of the increased seizures, the patient's post-ictal state was better and their appetite, sleep pattern and behavior were unchanged. Stimulation was gradually reduced over a period of one month prior to programming the device to off. It was reported that the patient had less frequent but more intense seizure without the vns therapy. It was also reported that during the time that the generator was programmed to off, the patient had several episodes of suddenly becoming unresponsive. There was a question of whether there was no heart rate or respiratory effort during these episodes, but by the time caregivers obtained a stethoscope, the patient was reportedly breathing and their heart rate had recovered. The patient was seen by a cardiologist who indicated that the patient was having syncope, but that since patient was a do not resusciate, no further workup was warranted. Caregivers are seeking second cardiac opinion.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=488323




Title: Re: Increase in seizures
Post by: dennis100 on November 27, 2011, 09:24:00 AM
Model Number 101
Event Date 01/01/2003
Event Type Injury Patient Outcome Life Threatening; Required Intervention
Event Description
Reporter indicated that vns patient has experienced worsening of seizures since last two programming sessions during which device settings were adjusted. It was reported that the patient used to have 3 to 5 seizures per month and occasionally went up to 3 months without a seizure. Since the last two adjustments in device settings, the patient is reportedly experiencing 4 to 5 seizures per month and has bumped their head, broken their ankle and bruised their back during these seizures. Treating neurologist increased both normal mode and magnet mode output current settings (from 1. 50ma to 1. 75ma and from 1. 75ma to 2. 0ma respectively). Neurologist indicated that it was not clear whether or not the seizure increase was above pre-vns baseline frequency and that the event was not related to the ncp system. Neurologist indicated that the patient's seizure types had not changed and that the patient's overall health condition was not worsening. There were reportedly no medication changes that may have contributed to the seizure increase. Neurologist did not know whether there were any environmental stimuli that may have contributed to the seizure increase.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=503923



Title: Re: Increase in seizures
Post by: dennis100 on November 27, 2011, 09:24:29 AM
Model Number 102R
Event Date 02/01/2004
Event Type Injury Patient Outcome Life Threatening;
Manufacturer Narrative
Further follow-up revealed that x-rays did not identify any discontinuities with the vns therapy system. Physician reduced the device duty cycle slightly. Physician indicated that the pt is doing much better experiencing a 25% reduction in seizures with an adjustment the pt's lamictal.

Event Description
Reporter indicated that patient has experienced an increase in seizures since generator replacement surgery and that the patient was having seizures during the day instead of at night as usual. The patient's complex partial seizures had increased but were not as severe as pre-vns. It is not known whether seizure increase is above pre-vns baseline frequency or whether it is simply an increase from previous efficacy with the vns therapy. Device diagnostic testing was within normal limits, indicating proper device function.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=516679



Title: Re: Increase in seizures
Post by: dennis100 on November 27, 2011, 09:25:01 AM
Event Date 01/01/2003
Event Type Injury Patient Outcome Disability; Required Intervention
Manufacturer Narrative
Report is incomplete because no response has been received to mfr's requests for additional info from treating neurologist.

Event Description
Reporter indicated that the patient has experienced an increase in seizures since re-implant surgery. The patient is being seen by neurologist every two weeks due to increase in seizures. It was also reported that the patient's speech has slowly decreased and that now patient is non-verbal. Report also indicated that the magnet has been effective when using it to abort the patient's seizures

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=516684



Title: Re: Increase in seizures
Post by: dennis100 on November 27, 2011, 09:37:33 AM
Event Date 01/01/2003
Event Type Injury Patient Outcome Disability; Required Intervention
Manufacturer Narrative
Report is incomplete because no response has been received to mfr's requests for additional info from treating neurologist.

Event Description
Reporter indicated that the patient has experienced an increase in seizures since re-implant surgery. The patient is being seen by neurologist every two weeks due to increase in seizures. It was also reported that the patient's speech has slowly decreased and that now patient is non-verbal. Report also indicated that the magnet has been effective when using it to abort the patient's seizures

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=516684


Title: Re: Increase in seizures
Post by: dennis100 on November 27, 2011, 09:38:26 AM
Model Number 102
Event Date 02/01/2004
Event Type Injury Patient Outcome Life Threatening; Required Intervention
Event Description
Reporter indicated that patient experienced an increase in seizures and incontinence after device output current was initially programmed to on (0. 5ma). It was reported that the patient experienced a few seizures per month prior to vns therapy system implant and after implantation prior to having the device programmed to on. After programming the device to on the patient experienced up to 3 seizures per day in combination with incontinence. The device was later programmed to off. The patient's family is willing to have the device programmed back to on; however, would like to wait until the patient is on holiday from school to prevent further embarrassment to the patient. It was also reported that the patient usually experiences seasonal deterioration around this time of year, however, it has never been this dramatic or sudden.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=516686


Title: Re: Increase in seizures
Post by: dennis100 on November 27, 2011, 09:40:41 AM
Model Number 102
Event Date 01/01/2003
Event Type Injury Patient Outcome Life Threatening; Required Intervention
Event Description
The explanted pulse generator was returned to mfr for analysis. No anomalies were noted via visual inspection and the device met electrical test specifications.

Manufacturer Narrative
The following dates are estimated. Only the year is known: b. 3, date of event.

Event Description
Reporter indicated that pt experienced an increase in seizures after vns implant. The device was programmed to off for one week, after which the pt had no seizures. When the device was programmed back to on, the pt's seizures again increased. Normal mode output current is currently programmed to off (oma), but magnet mode output current is still programmed to on. The pt has requested explant of the vns and plans to pursue epilepsy surgery as they are a candidate for temporal lobectomy.

Event Description
Further follow-up revealed that the patient was explanted due to undergoing brain surgery. It was reported that the brain surgery cured the patient's seizures and that vns therapy was no longer needed. Neurosurgeon indicated that the patient is healing well since explant. It is unnkown if the bipolar lead was also explanted or left in situ.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=516729


Title: Re: Increase in seizures
Post by: dennis100 on November 27, 2011, 09:41:27 AM
Model Number 101
Event Date 01/01/2004
Event Type Injury Patient Outcome Life Threatening;
Event Description
Reporter indicated that pt has experienced an increase in seizures since generator replacement surgery. It is not known whether the seizure increase is above pre-vns baseline frequency or whether it is simply an increase from previous efficacy with the vns therapy. It was reported that the pt was seizure-free for seven months prior to generator replacement and the pt is now having more seizures. Device diagnostic testing was within normal limits, indicating proper device function.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=516753



Title: Re: Increase in seizures
Post by: dennis100 on November 27, 2011, 09:42:28 AM
Model Number 102
Event Date 02/13/2004
Event Type Injury Patient Outcome Life Threatening; Required Intervention

Event Description
Reporter indicated that vns pt experienced an increase in seizures with the vns therapy. It was reported that stimulation was initiated 16 days post-implant and that the pt did well on the day of activation and the morning after, but that pt then experienced an increase in seizures above pre-vns baseline frequency. It was reported that the pt had a seizure every time the device stimulated with both normal mode and magnet mode stimulation. There were reportedly no medication changes prior to the increase in seizures. Normal mode output current was programmed to off (oma), but magnet mode output current was left at 0. 25 ma and pt's topamax dosage was increased. The pt is scheduled for video eeg monitoring. The pt's family member wants the vns therapy system explanted.

Manufacturer Narrative
Report is incomplete because no response has been received to manufacturer's request of additional info from treating neurologist. H. 6. : review of manufacturing records for both the pulse generator and the bipolar lead revealed no anomalies that would adversely effect device performance. 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.

Manufacturer Narrative
Further follow-up revealed that the pt experiences photophobia and irritability. The pt's family member wants the device to be explanted. Neurologist indicated that a recent eeg did not show an increase in seizures and there are no plans to explant the pt's device. Neurologist feels that the pt's issues may be behavioral.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=515986



Title: Re: Increase in seizures
Post by: dennis100 on November 27, 2011, 09:43:44 AM
Model Number 102
Event Date 10/23/2003
Event Type Injury Patient Outcome Life Threatening;
Manufacturer Narrative
Report is incomplete because no response has been received to mfr's request for additional info from treating neurologist. 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 patient has experienced an increase in seizures since vns implant. According to initial reporter, the patient reportedly experienced 1 seizure every other week before vns implant, but now experiences 3 seizures per day. Treating neurosurgeon has documented patient's pre-vns seizure history as being an average of once per week up to 5 or 6 times per week.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=515574



Title: Re: Increase in seizures
Post by: dennis100 on November 27, 2011, 09:44:20 AM
Model Number 102
Event Date 02/01/2004
Event Type Injury Patient Outcome Life Threatening; Required Intervention
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 adolesecents 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
The pt experienced an increase in seizures. The increase in seizures occurred when the vns output was increased. The pt had strep throat which might have contributed to the increase in seizures. The pt experienced shortness of breath and had swallowing problems. These problems resolved when the vns output was decreased.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=523050


Title: Re: Increase in seizures
Post by: dennis100 on November 27, 2011, 09:45:03 AM
Event Date 02/06/2004
Event Type Injury Patient Outcome Life Threatening; Hospitalization
Manufacturer Narrative
Report is incomplete because initial reporter would not provide patient info to mfr due to hipaa regulations.

Event Description
Reporter indicated that vns patient was in hospital emergency room due to an increase in seizures. The patient had reportedly not had their device checked by a neurologist in over a year. Er physician gave the patient names and phone number of local neurologists that are familiar with the vns therapy, as the patient was new to the area.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=514365


Title: Re: Increase in seizures
Post by: dennis100 on November 27, 2011, 09:45:46 AM
Model Number 102
Event Type Malfunction
Manufacturer Narrative
H. 6. : device mfg records were reviewed. H. 6. Review of mfg records for both the pulse generator and the bipolar lead revealed no anomalies that would adversely effect device performance. H. 6. The vns therapy system is indicated for use as an adjunctive therapy in reducing the frequency of seizures in adults and adolescents over 12 years of age 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 over 12 years of age with partial onset seizures that are refractory to antiepileptic medications. The following dates are estimated. Only the month/year is known: d. 8, explant date.

Event Description
Device diagnostic testing at office visit resulted in high lead impedance reading (dc-dc code 7), indicating possible device malfunction. The elective replacement indicator was yes, indicating the generator has reached end of svc. Device diagnostic testing at last office visit 9 mos prior was within normal limits, indicating proper device function at that time. The pt has reportedly experienced an increase in seizures over the past 2 or 3 mos. X-rays reviewed by neurologist revealed that the lead connector pin does not appear to be fully inserted into the generator header. The pt has not suffered any injury or trauma that may have damaged the vns therapy system. It is suspected that the bad connection between the lead and generator may have caused premature end of svc due to excessive current drainage. The reason for the apparent connection problem has not yet been ascertained.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=532473



Title: Re: Increase in seizures
Post by: dennis100 on November 27, 2011, 09:47:13 AM
Model Number 102
Event Date 02/01/2004
Event Type Injury Patient Outcome Hospitalization; Required Intervention
Manufacturer Narrative
Product analysis results will not change the conclusion of the reported event because explanted products are decontaminated prior to return; therefore, microbiological testing is not performed. In the event that the device is explanted and returned, product analysis results will only be reported if a device malfunction is noted that would be likely to cause or contribute to a death or serious injury if the malfunction were to recur. H. 6. Vns therapy system labeling lists infection as a potential adverse event possibly associated with surgery. Review of manufacturing records for both the pulse generator and the bipolar lead confirmed sterilization of devices.

Event Description
Reporter indicated that vns pt had developed an infection and was experiencing an increase in seizures. The pt was traveling out of the country at the time of the event. The pt went to hosp e. R. Because pt was having severe pain at the generator site. The generator site was warm to the touch and there were 3 small red dots that appeared on their incision. The hosp did not known how to deal with the vns therapy system, so the pt was presecribed darvocet and discharged. The pt has not suffered any injury or trauma that may have damaged the vns therapy system and has no fever with the pain. It was reported that the pt fell after an increase in seizure activity approximately 5 months prior and was hospitalized for a week at that time. Since then, the pt has had a decreased appetite and has lost 40 to 50 pounds. Further follow-up revealed that the pt went to another hosp where infection was confirmed via blood work. The pt's temperature was just under 100 degrees f. The pt was prescribed iv antibiotics and then discharged with a prescription of oral antibiotics. The pt was reportedly feeling much better and was eating again. The pain and rash at the generator site had both resolved. It was reported that approximately 48 hours after starting the oral antibiotics, the pt had 6 seizures in a 12-hour period. The pt subsequently stopped taking the antibiotics and the pain pills that were prescribed by the hosp and has since been seizure-free. The pt planned to follow-up with a neurologist, but returned to the hosp because their low grade fever and pain had returned. A different antibitotic was prescribed.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=515394



Title: Re: Increase in seizures
Post by: dennis100 on November 27, 2011, 09:47:52 AM
Model Number 300-20
Event Type Malfunction
Manufacturer Narrative
H. 6. Review of manufacturing records for both the pulse generator and the bipolar lead revealed no anomalies that would adversely effect device performance.

Event Description
Reporter indicated that device diagnostic testing at office visit resulted in high lead impedance reading (dc-dc code 7 and limit), indicating possible device malfunction. The elective replacement indicator was no, indicating the generator had not reached end of service. It was reported that the patient had recently experienced an increase in seizure activity and may have fallen with one of their seizures, potentially causing damage to the ncp system. Review of x-rays by radiologist revealed no obvious discontinuities in the ncp system. The device was programmed to off pending ncp system replacement surgery.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=515688


Title: Re: Increase in seizures
Post by: dennis100 on November 27, 2011, 09:48:37 AM
Model Number 101
Event Date 01/01/2004
Event Type Injury Patient Outcome Life Threatening;
Manufacturer Narrative
Report is incomplete because no response has been rec'd to mfr's request for add'l info from treating neurologist.

Event Description
Pt's seizure types have changed. The pt started having blackout seizures again during school and that pt had not had those types of seizures since grade school.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=523057



Title: Re: Increase in seizures
Post by: dennis100 on November 27, 2011, 09:49:23 AM
Model Number 102
Event Date 03/01/2004 Event Type Injury
Patient Outcome Life Threatening;
Event Description
Reporter indicated that pt has recently experienced an increase in seizures. It was reported that the pt experienced 1-2 seizures per year prior to vns implant and that pt recently experienced 3 seizures within one month. Treating neurologist indicated that the pt was doing fine and that the reported event was not related to the vns. The pt's seizures types had not changed. The pt's health condition is reportedly not worsening and there were no environmetal stimuli that may have contributed to the increase in seizure activity. Neurologist indicated that programming the pt's device to off resulted in no change to the pt's condition or symptoms.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=522645



Title: Re: Increase in seizures
Post by: dennis100 on November 27, 2011, 09:50:08 AM
Model Number 102
Event Date 01/01/2004
Event Type Injury Patient Outcome Life Threatening;
Manufacturer Narrative
Report is incomplete because no response has been rec'd to mfr's request for add'l info from initial reporter.

Event Description
Reporter indicated that pt was experiencing an increase in night time seizures as well as an increase in seizures at school. Investigation to date has been unable to determine whether the seizure increase is above pre-vns baseline frequency.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=522649


Title: Re: Increase in seizures
Post by: dennis100 on November 27, 2011, 09:50:53 AM
Model Number 300-20
Event Type Malfunction
Manufacturer Narrative
H6. 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. 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 device diagnostic testing at office visit resulted in high lead impedance reading (dc-dc code 7 and limit), indicating possible device malfunction. The elective replacement indicator was no, indicating that the generator was not at end of service. The patient is reportedly experiencing an increase in seizures. Review of x-rays by physician revealed a break in the lead.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=557851



Title: Re: Increase in seizures
Post by: dennis100 on November 27, 2011, 09:56:20 AM
Model Number 101
Event Date 01/01/2004
Event Type Injury Patient Outcome Life Threatening; Required Intervention
Manufacturer Narrative
Report is incomplete because no response has been received to manufacturer's requests for additional info from treating neurologist.

Event Description
Reporter indicated that vns pt was experiencing an increase in seizures. Device diagnostic testing was within normal limits, indicating proper device function. The elective replacement indicator was no, indicating that the generator was not at end of service. Device settings were adjusted. Investigation to date has been unable to determine whether the seizure increase was an increase from previous efficacy with the vns therapy or an increase above pre-vns baseline frequency.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=518949



Title: Re: Increase in seizures
Post by: dennis100 on November 27, 2011, 09:58:09 AM
Model Number 300-20
Event Date 01/01/2004
Event Type Injury Patient Outcome Life Threatening;
Manufacturer Narrative
Report is incomplete because no response has been received to manufacturer's request for additional info from treating neurologist. H. 6. Review of mfg records for both the pulse generator and the bipolar lead revealed no anomalies that would adversely effect device performance.

Event Description
Reporter indicated that vns pt was experiencing an increase in seizures and that pt was no longer able to feel magnet mode stimulation. It was reported that pt recently experienced a fall that resulted in bruising to their eyes, but no apparent trauma to the area of the ncp system. Investigation to date has been unable to determine if the increase in seizures was an increase above previous efficacy experienced with the vns therapy or an increase above pre-vns baseline frequency. Additionally, investigation to date has been unable to determine whether the device has reached normal end of service or whether the device was functioning properly.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=519012




Title: Re: Increase in seizures
Post by: dennis100 on November 27, 2011, 09:59:06 AM
Model Number 102
Event Date 02/24/2004
Event Type Injury Patient Outcome Life Threatening; Hospitalization Required Intervention
Event Description
Reporter indicated that vns patient experienced an increase in seizure intensity since implantation. It was reported that the patient was seen in hosp e. R. Approx one month post-implant due to an episode of status epilepticus. The patient was seen again in the e. R. Less than two weeks later having had a seizure that lasted for 22 hours. Device output current was increased to 0. 75ma and the patient has reportedly had some improvement with less severe seizures. No medication changes have been made. It was reported that the patient's overall health condition is not worsening. There are no known environmental stimuli that may have contributed to the increase in seizure intensity, although the patient was reportedly nervous at the time of the events. Device diagnostic testing was within normal limits, indicating proper device function. Treating neurologist indicated that the events were not related to the vns and that the cause is unknown.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=519537


Title: Re: Increase in seizures
Post by: dennis100 on November 27, 2011, 09:59:52 AM
Model Number 102   
Event Date 10/01/2002
Event Type Injury Patient Outcome Life Threatening; Required Intervention
Manufacturer Narrative
H. 6. Vns therapy system labeling lists dyspena, neck pain, incision site pain, dizziness, increased coughipng, insomnia and tinnitus as potential adverse events possibly associated with surgery or stimulation.
Event Description
Reporter indicated that patient's device was programmed to off due to adverse side effects. It was reported that the patient was experiencing neck and chest pain with shortness of breath and an increase in seizures. The patient reported that they have been having large seizures like they had before they were implanted with the vns. The patient reports that they sometimes fall with their seizures. Treating neurologist indicated that the patient currently complains of dizziness most of the time, lack of energy, some night time coughing, shortness of breath at times and continuous pain around the generator and along the left side of the neck. The patient also has trouble sleeping and has a noise in their ears at times. It was reported that the increase in seizures was above the patient's pre-vns baseline frequency and that the patient's device was programmed to off to see if symptoms subside wihtout the vns therapy. The device remains programmed to off at this time. Further follow-up revealed that the patient perviously experienced an increase in seizures shortly after implant. The patient's device was programmed to off approx two months after stimualtion was intiated and was programmed back to on two months later.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=519523




Title: Re: Increase in seizures
Post by: dennis100 on November 27, 2011, 10:00:30 AM
Model Number 300-20
Event Date 12/16/2003
Event Type Malfunction
Manufacturer Narrative
Device manufacturing records were reviewed. Review of mfg records for both the pulse generator and the bipolar lead revealed no anomalies that would adversely affect device performance.

Event Description
Device diagnostic testing at office visit resulted in high lead impedance reading indicating possible device malfunction. The pt was experiencing an increase in seizures for the past two weeks and had fallen and broken their arm one week before office visit. It was reported that the pt had undergone generator replacement surgery approx 3 months prior. It is not known whether intraoperative diagnostic testing was performed at the time of generator replacement surgery, but post implant testing of the device approx 2 months prior to high lead impedance reading was within normal limits, indicating proper device function at that time. Review of x-rays did not reveal any obvious discontinuities in the ncp system. Revision surgery was performed during which the lead pins were removed from the generator and reinserted. Subsequent device diagnostic testing was within normal limits. No product was explanted and the pt was closed

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=549503




Title: Re: Increase in seizures
Post by: dennis100 on November 27, 2011, 10:01:13 AM
Model Number 102
Event Date 01/27/2004
Event Type Injury Patient Outcome Life Threatening; Required Intervention
Event Description
Reporter indicated that patient has experienced an increase in seizures since initially programming the device on to. 25ma. Neurologist also indicated that the patient's device was programmed off approx 6 weeks later. Neurologist reported that the patient has not experienced any recent changes in medication that could be contributing to the increase in seizures. Further follow-up revealed that the pt experienced approx 30-40 seizures per month pre-vns therapy system implant. Neurologist indicated that prior to programming the device to off, device output current was increased to. 50ma. Neurologist also indicated that after programming the device to off the pt's seizures improved back to pre-vns baseline. Neurologist plans to program the pt's device back to on at low settings within a few weeks. Neurologist indicated that the vns therapy system is related to the increase in seizures.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=519791


Title: Re: Increase in seizures
Post by: dennis100 on November 27, 2011, 10:02:35 AM
Model Number 300-20
Event Type Malfunction
Manufacturer Narrative
H. 6. Device manufacturing records were reviewed h. 6. Review of manufacturing records for both the pulse generator and the bipolar lead revealed no anomalies that would adversely effect device performance.

Event Description
Device diagnostic testing at office visit resulted in high lead impedance reading indicating possible device malfunction. The elective replacement indicator was no, indicating that the generator was not at end of service. It was also reported that the pt had had an increase in seizures above previous efficacy with the vns therapy, but not an increase above pre-vns basline frequency. There have been no recent medication changes or adjustments to programmed parameters that may have contributed to the increase in seizure frequency. It was reported that the pt's seizure types had not changed and that their overall health condition was not worsening. There were no environmental stimuli that could have caused the increase in seizures. X-rays reviewed by neurologist did not reveal any obvious discontinuities in the ncp system. The pt reports no recent injury or trauma that may have damaged the ncp system. Ncp system replacement surgery is planned.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=548927



Title: Re: Increase in seizures
Post by: dennis100 on November 27, 2011, 10:03:25 AM
Event Type Malfunction
Event Description
Vns pt can no longer feel magnet mode stimulation and has to swipe the device at least 6 times with the magnet before they feel it stimulate. It was also reported that the pt's seizures are returning to pre-vns baseline frequency. The pt has continued to experience clusters of seizures with the vns therapy, but is now having daily seizure activity as well as breakthrough clusters of seizures. The pt plans to follow up with their neurologist. Investigation to date has been unable to determine whether the device is functioning properly.

Manufacturer Narrative
Report is incomplete becuase no response has been received to mfr's request for additional info from treating neurologist.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=548897


Title: Re: Increase in seizures
Post by: dennis100 on November 27, 2011, 10:04:01 AM
Model Number 101
Event Date 01/01/2004
Event Type Injury Patient Outcome Life Threatening; Hospitalization Required Intervention
Manufacturer Narrative
Report is incomplete because no response has been received to mfr's requests for additional info from treating neurologist. H. 6. Ncp system labeling lists weight change as a potential adverse event possibly associated with surgery or stimulation.

Event Description
Reporter indicated that the pt was recently hospitalized due to an increase in seizures. The pt's medications were increased during their hospital stay. The increase in seizures is an increase above previous efficacy with the vns therapy and not an increase above pre-vns baseline frequency. The reporter also stated that the pt has recently been ill with gastroenteritis and has lost 10 lbs. In the last week. It was also reported that the pt can feel the device stimulating; however, activating the device with the magnet was not aborting the pt's seizures. Investigation to date has been unable to determine whether the device has reached or is nearing normal end of service.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=520256




Title: Re: Increase in seizures
Post by: dennis100 on November 27, 2011, 10:05:16 AM
Model Number 101
Event Date 03/01/2004
Event Type Injury Patient Outcome Hospitalization;
Event Description
The reporter indicated that the pt was admitted to the hospital due to intractable epilepsy. It was also reported that the pt's vns device has stopped working and that it used to work "great" for the pt. The pt reportedly began having seizures like pt used to before vns implant.

Manufacturer Narrative
The vns device may have reached end-of-service. Report is incomplete because no response has been received to mfr's requests for additional info from treating neurologist.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=520198




Title: Re: Increase in seizures
Post by: dennis100 on November 27, 2011, 10:06:34 AM
Event Date 01/01/2003
Event Type Injury Patient Outcome Life Threatening;
Manufacturer Narrative
Report is incomplete because no response has been received to mfr's request for additional info from treating neurologist. H. 6. Ncp system labeling states that during stimulation, the pulse generator may interfere with devices operating in the 40 khz to 100 khz range, such as pocket transistor radios and hearing aids. This interference is a theoretical possibility, and no effects on hearing aids have yet been reported, although the pulse generator can interfere with a transistor radio when held directly over one. No specific testing has been done to date, and no definite info on effects is available.

Event Description
Reporter indicated that vns patient has recently experienced an increase in seizures. It was reported that the pt wears hearing aids and has recently begun laser treatments on their ears to try to restore some of their hearing. The pt has reportedly experienced an increase in seizures since beginning the laser treatments. Investigation to date has been unable to determine whether the increase in seizures is an increase from previous efficacy with the vns therapy or an increase above pre-vns baseline frequency. Pre-vns seizure frequency is reported as 10-12 seizures per week.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=520242



Title: Re: Increase in seizures
Post by: dennis100 on November 27, 2011, 10:08:40 AM
Model Number 102
Event Date 03/01/2004
Event Type Injury Patient Outcome Life Threatening;
Manufacturer Narrative
Report is incomplete because no response has been received to manufacturer's requests for additional information from treating neurologist.

Event Description
The reporter indicated that for approximately one week, the pt has experienced an increase in seizures. No adverse events were reported. Investigation to date has been unable to determine whether the seizure increase was an increase above previous efficacy with the vns therapy or an increase above pre-vns baseline frequency.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=520198



Title: Re: Increase in seizures
Post by: dennis100 on November 27, 2011, 10:09:33 AM
Model Number 102
Event Date 01/01/2004
Event Type Injury Patient Outcome Life Threatening;
Manufacturer Narrative
Report is incomplete because no response has been received to manufacturer's requests for additional information from treating neurologist.

Event Description
The reporter indicated that the pt is experiencing pain at the generator site and has had an increase in seizures. The reporter also indicated that the increase in seizures may be due to stress or tapering the pt off of their anti-epileptic medication. Investigation to date has been unable to determine whether the pt's chest pain is cardiac-related or whether the increase in seizures is above the pt's pre-vns baseline frequency.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=520795




Title: Re: Increase in seizures
Post by: dennis100 on November 27, 2011, 10:10:53 AM
Model Number 100
Event Date 07/01/2003
Event Type Injury Patient Outcome Life Threatening;
Manufacturer Narrative
H. 6. Review of manufacturing records for both the pulse generator and the bipolar lead revealed no anomalies that would adversely effect device performance.

Event Description
Reporter indicated that vns pt has experienced "lots of" petite mal seizures over an eight-month period and can no longer feel magnet mode stimulation. The pt also complained of hoarseness during this time along with a more recent earache. The pt was reportedly diagnosed with carotid inflammation by an ent. Treating neurologist indicated that it was unk whether the pt's symptoms were related to the vns therapy. Investigation to date has been unable to determine whether the pt has experienced an increase in seizure activity above pre-vns baseline frequency.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=521626



Title: Re: Increase in seizures
Post by: dennis100 on November 27, 2011, 10:11:45 AM
Model Number 102
Event Date 07/16/2003
Event Type Injury Patient Outcome Life Threatening; Required Intervention
Manufacturer Narrative
H. 6. Review of mfg 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 an increase in seizure frequency following vns therapy system replacement surgery. The pt reportedly experienced 2-3 seizures per day before replacement surgery due to end of service of their original system. Since system replacement surgery, the pt has experienced 10-15 seizures per day. Adjustments to device settings and medications have not resolved the increase in seizure activity. Investigation to date has been unable to determine whether the increase in seizures is above pre-vns baseline frequency.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=521796




Title: Re: Increase in seizures
Post by: dennis100 on November 27, 2011, 10:12:58 AM
Model Number 102
Event Date 03/01/2004
Event Type Injury Patient Outcome Life Threatening; Hospitalization Required Intervention
Manufacturer Narrative
Report is incomplete because no response has been received to manufacturer's requests for additional info from treating neurologist. 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 antepileptic 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 medication.

Event Description
Pt is experiencing more drop attacks and grand mal seizures than before vns implant. Treating neurologist had been making adjustments to device settings in an attempt to acheive efficacy. The pt was seen in hospital emergency room with an increase in atonic seizures at which time treating neurologist made additional adjustments to device settings.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=522106



Title: Re: Increase in seizures
Post by: dennis100 on November 27, 2011, 10:14:07 AM
Model Number 102
Event Type Malfunction
Model Number 102
Manufactturer Narrative
Review of manufacturing records for the pulse generator revealed no anomalies that would adversely effect device performance. 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 device diagnostic testing at office visit resulted in high lead impedance reading (dc-dc code 7 and limit), indicating possible device malfunction. The elective replacement indicator was no, indicating that the generator was not at end of service. It was also reported that the patient had experienced a recent increase in seizure activity. Review of x-rays did not reveal any obvious discontinuities in the vns therapy system. The patient underwent revision surgery during which the lead pins were noted to be loosely connected to the generator. Surgeon indicated that he remembered hearing the tightening clicks and seeing the lead pin visible past the connector blocks at the time of initial implant, indicating that the lead was properly connected at that time. The lead pins were removed from the generator and then reconnected. Subsequent device diagnostic testing was within normal limits, indicating proper device function, but surgeon reportedly believed that there may be something wrong with the set screw on the original generator as he could not explain why the lead pins became loose after initial implant. The generator was explanted and a new generator was implanted with the original lead.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=557862




Title: Re: Increase in seizures
Post by: dennis100 on November 27, 2011, 10:15:34 AM
Event Date 01/01/2003
Event Type Injury Patient Outcome Disability; Required Intervention
Manufacturer Narrative
Report is incomplete because no response has been received to mfr's requests for additional info from treating neurologist.

Event Description
Reporter indicated that the patient has experienced an increase in seizures since re-implant surgery. The patient is being seen by neurologist every two weeks due to increase in seizures. It was also reported that the patient's speech has slowly decreased and that now patient is non-verbal. Report also indicated that the magnet has been effective when using it to abort the patient's seizures

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=516684


Title: Re: Increase in seizures
Post by: dennis100 on November 28, 2011, 03:31:56 AM
Model Number 101
Event Date 12/01/2003
Event Type Injury Patient Outcome Life Threatening; Hospitalization Required Intervention Event Description
Reporter indicated that vns patient was seen in hospital emergency room due to seizures. Further follow-up revealed that the patient began to experience blackout episodes and totally lose consciouness. It was reported that the patient sometimes stopped breathing during these episodes. During one of these episodes, the pt's family member swiped the device with the magnet and the pt reportedly regained consciousness. The pt was seen in the hospital emergency room at which time the er physician reportedly indicated that the pt's medicaion levels were toxic. The pt's tegretol and dilantin were discontinued at that time. At subsequent follow-up visit with treating neurologist, the pt's medication were restarted, valium was added to their drug regimen and the device magnet mode output current was increased. Before the increase in magnet mode output current, it had been programmed to the same stimulation level as the normal mode output current. Treating neurologist indicated that the device was functioning properly at that time. These adjustments reportedly worked well for the pt for approx two weeks, after which the episodes recurred and the pt was again seen in the hospital emergency room. Drug levels were reportedly not toxic at the time of the second emergency visit. The pt's family member is unhappy with the pt's current neurologist and has scheduled follow-up with a new neurologist who reportedly plans to perform an eeg.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=504875


Title: Re: Increase in seizures
Post by: dennis100 on November 28, 2011, 03:32:33 AM
Model Number 300-20
Event Date 01/01/2003
Event Type Malfunction
Manufacturer Narrative
H. 6. Review mfg records for both the pulse generator and the bipolar lead revealed no anomalies that would adversely effect device performance.

Event Description
Reporter idicated that pt was seen for neurosurgical consult regarding battery replacement, but was referred to their original neurosurgeon due to suspectecd lead malfunction. Further follow-up revealed that the pt experienced facial pain with stimulation during device diagnostic testing. It was also reported that the pt had experienced an increase in seizures. Investigation to date has been unable to determine the nature of the suspected lead malfunction and whether or not the increase in seizures is above pre-vns baseline frequency.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=509971


Title: Re: Increase in seizures
Post by: dennis100 on November 28, 2011, 03:33:15 AM
Model Number 101
Event Date 01/01/2003
Event Type Injury Patient Outcome Life Threatening; Required Intervention
Manufacturer Narrative
Report is incomplete because no response has been received to manufacturer's requests for additional information from treating neurologist. H. 6. Ncp system labeling states that the safety and efficacy of this therapy have not been systematically established for uses not covered in the "intended use/indications" section of device labeling or in patients with history of previous therapeutic brain surgery.

Event Description
Vns pt was experiencing an increase in seizures. Investigation to date has been unable to determine whether the seizure increase was above pre-vns baseline frequency or simply an increase over previous efficacy with the vns therapy. The pt coughs a lot and experiences throat discomfort with stimulation, but they do not have any problems swallowing. Device diagnostic testing was within normal limits, indicating proper device function. Treating neurologist indicated that he was going to attempt adjustments in device setting in an effort to decrease the adverse side effects that the pt was experiencing and increase efficacy.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=505621



Title: Re: Increase in seizures
Post by: dennis100 on November 28, 2011, 03:33:58 AM
Model Number 101
Event Date 01/01/2003
Event Type Injury Patient Outcome Life Threatening;
Event Description
Further follow-up revealed that the pt's device was programmed off approx 1 yr prior. The pt's family member also indicated that the pt developed intracranial hypertension and had to have a gastrostomy tube inserted because vns therapy "killed their hunger" and the pt would not eat. The pt's family member reported that the pt is on the ketogenic diet at this time and is doing okay.

Manufacturer Narrative
Report is incomplete because no response has been received to manufacturer's requests for additional information from treating neurologist.

Event Description
Reporter indicated that vns pt was experiencing an increase in seizures. It was reported that pre-vns, the pt only had seizures 2-3 times per month and that now pt has them every day. Additionally, it was reported that the pt experienced a seizure that lasted for 40 minutes. The patient's drug regimen had been changed due to recently diagnosed papilledema.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=505604



Title: Re: Increase in seizures
Post by: dennis100 on November 28, 2011, 03:34:34 AM
Model Number 102
Event Date 11/24/2003
Event Type Injury Patient Outcome Life Threatening; Required Intervention
Event Description
Reporter indicated that vns patient had experienced an increase in seizures above their pre-vns baseline frequency. It was reported that there had been no recent changes to the patient's drug regimen that may have contributed to the seizures increase. Further follow-up revealed that the patient's device has been programmed to off due to the seizure increase and that their seizure frequency and intensity had returned to pre-vns levels. Treating physician indicated that the seizure increase occurred immediately after stimulation was initiated and that she believed that the event was related to the vns therapy system. The pt reportedly experienced 2-3 seizures per week pre-vns. After initiation of stimulation, the pt reportedly expereinced 3-4 seizures per week and they were more severe. The patient's seizure types have not changed. It was reported that the patient's overall health condition was not worsening, but that the pt had lost their job after having a seizure at work. No device diagnostic testing has been performed.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=505718


Title: Re: Increase in seizures
Post by: dennis100 on November 28, 2011, 03:35:17 AM
Model Number 101
Event Date 11/01/2003
Event Type Malfunction
Event Description
Reporter indicated that pt's stimulation no longer felt like it normally did. It was reported that for a couple of weeks, the pt does not feel stimulation cycle begin and experiences pain at the generator site with stimulation. The pt has experienced an increase in seizures as compared to previous efficacy with the vns therapy but not above pre-vns baseline frequency. Further follow-up revealed that the pt's seizures have become more violent at night for the past 7 months. There have been no recent changes to device settings or to the pt's drug regimen that would contribute to the seizure increase. Device diagnostic testing was within normal limits, indicating proper device function. The elective replacement indicator was no, indicating that the generator was not at end of service. Device magnet mode output current was increased at last office visit because the pt indicated that they could no longer feel magnet mode stimulation. Treating neurologist indicated that the pt's pain and increase in seizures were not related to the vns. The pt had been diagnosed with gastritis that is believed to have altered the pt's metabolic state resulting in inadequate absorption of anti-epileptic medicines. Investigation to date has been unable to confirm whether the magnet mode stimulation is functioning properly. It is not known whether the pt can feel magnet mode stimulation since the increase in output current as pt has not shown up for the last two scheduled follow-up appointments with the neurologist.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=510212



Title: Re: Increase in seizures
Post by: dennis100 on November 28, 2011, 03:36:22 AM
Model Number 100
Event Date 01/01/1999
Event Type Injury Patient Outcome Life Threatening; Hospitalization Required Intervention
Manufacturer Narrative
Report is incomplete because no response has been received to manufacturer's requests for additional information from treating neurologist. H. 6. Device programming history was reviewed. H. 6 review of device programming history revealed no anomailes. H. 6 ncp system labeling cautions the patients with obstructive sleep apnea (osa) may have increased apneic event during stimulation. Cyberonics recommends care when treating patients with preexisting osa. Lowering stimulus frequency or prolonging off time may prevent exacerbation of osa.

Event Description
In the process of contacting the patient to notify patient that their device may be nearing end of service, it was discovered that the patient's device had been programmed to off for appoximately 4 months due to atonic seizures. It was reported that the patient began having atonic seizures after vns implant. The patient's device was programmed to rapid cycling, but at low settings since the patient wanted their voice changes with stimulation to be less noticeable. The patient was hospitalized for long-term monitoring for one week during which time the vns was programmed to off and their eeg reportedly improved. The vns was later permanently programmed to off and the patient has since experienced no grand mal seizures and no atonic seizures, but patient continues to experience a lot of petit mal and partial complex seizures. Neurologist is reportedly considering explant of the generator.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=506520



Title: Re: Increase in seizures
Post by: dennis100 on November 28, 2011, 03:37:01 AM
Event Date 08/05/2003
Event Type Injury Patient Outcome Life Threatening; Hospitalization
Event Description
Reporter indicated that vns patient's seizure frequency has increased from pre-vns baseline. There have reportedly been no changes to the patient's drug regimen, but the pt has been on antibiotics for an upper respiratory infection. The device output current settings have been gradually increased by 0. 25ma increments since initiation of stimulation to the current settings of 2. 0ma for normal mode and 2. 25ma for magnet mode. Patient's family member later reported that the pt had been hosptialized several times for facial twitching. The twitching reortedly began when programmed output current was increased to "full capacity. " the patient's family member indicated that treating neurologist increased device settings to the highest level in hopes that the pt may be able to decrease some of their medications.

Manufacturer Narrative
Report is incomplete because no response has been received to manufacturer's requests for additional info from treating neurologist. H. 6: vns therapy system labeling lists ataxia (muscle movements or twitching, generally associated with stimulation) as a potential adverse event possibly associated with surgery or stimulation.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=506852



Title: Re: Increase in seizures
Post by: dennis100 on November 28, 2011, 03:37:40 AM
Model Number 302-20
Event Date 01/25/2004
Event Type Malfunction
Manufacturer Narrative
H. 6. Review of manufacturing records for both the pulse generator and the bipolar lead revealed no anomalies that would adversely effect device performance. Review of x-ray did not reveal any obvious discontinuities in the vns therapy system.

Event Description
Reporter indicated that device diagnostic testing at office visit resulted in high lead impedance readings (dc-dc ode 7 and high), indicating possible device malfunction. The elective replacement indicator was no, indicating that the generator had not reached end of service. It was reported that the pt had experienced an increase in seizures and that pt claimed that their device had stopped working. Review of x-rays did not reveal any obvious discontinuities in the vns therapy system. The pt underwent an exploratory surgery during which the generator/lead connections were verified as acceptable and the generator was tested separately from the lead with normal results. Two weeks later the pt underwent lead replacement surgery. Intraoperative device diagnostic testing of the new lead connected to the original generator was within normal limits. Lead break is suspected.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=528674



Title: Re: Increase in seizures
Post by: dennis100 on November 28, 2011, 03:38:35 AM
Event Date 12/01/2003
Event Type Injury Patient Outcome Life Threatening; Hospitalization
 Manufacturer Narrative
Report is incomplete because no response had been received to manufacturer's requests for additional information from treating neurologist.

Event Description
Reporter indicated that vns pt has recently experienced an increase in their grand mal seizures from 4/month to 3-4/week. It was reported that the pt went to the hospital emergency room, but that they could not help because they did not know how to deal with the vns therapy system. It was also reported that use of the magnet no longer interrupts the pt's seizures. The pt plans to contact their neurologist for follow-up.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=507336


Title: Re: Increase in seizures
Post by: dennis100 on November 28, 2011, 03:39:25 AM
Model Number 300-20
Event Date 01/01/2003
Event Type Malfunction
Manufacturer Narrative
The pt had previously complained of their neck becoming "locked in certain positions if the system is going off and their neck is turned a certain way. " neurologist indicated at that time that the pt was experiencing "intermittent left sternocleidomastoid spasm" not necessarily related to stimulation as the pt could not really feel stimulation. X-rays at that time did not reveal any obvious discontinuities in the ncp system. H. 6. Review of manufacturing records for both the pulse generator and the bipolar lead reveealed no anomalies that would adversely effect device performance.

Event Description
Reporter indicated that device diagnostic testing at office visit resulted in high lead impedance reading (dc-dc code 7 and limit), indicating possible device malfunction. The elective replacement indicator was no, indicating that the generator had not reached end of service. It was reported that the pt has experienced an increase in seizures and muscle twitching in their neck. The pt was pregnant at the time the high lead impedance readings were obtained and has since given birth. X-ray results are pending. Further follow-up revealed that the pt experienced an increase in seizures over the past year, but that pt was tapered off of their usual medications (carbatrol & depakote) prior to becoming pregnant. The pt's seizures decreased after pt had the baby. Treating neurologist indicated that the relationship between the increase in seizures and the ncp system was unk. Neurologist plans to review x-ray for possible discontinuities in the ncp system.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=516301



Title: Re: Increase in seizures
Post by: dennis100 on November 28, 2011, 03:40:20 AM
Model Number 102
Event Date 11/01/2003
Event Type Injury Patient Outcome Life Threatening; Disability
Event Description
Reporter indicated that vns pt has experienced an increase in seizure activity since implant. It was also reported that pre-vns implant, the pt would experience episodes of blindness for 4-5 minutes and that since implant the episodes last for up to 1 1/2 hours.

Manufacturer Narrative
H6: the vns therapy system is indicated for use as an adjunctive therapy in reducing the frequency of seizures in adults and adolescents over 12 years of age with partial onset seizures that are refractory to antiepileptic medications. In the us the vns therapy system is approved for use in adults and adolescents over 12 years of age with partial onset seizures that are refractory to antiepileptic medications.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=508389



Title: Re: Increase in seizures
Post by: dennis100 on November 28, 2011, 03:42:06 AM
Model Number 102
Event Date 10/01/2003
Event Type Injury Patient Outcome Life Threatening; Required Intervention

Event Description
Further follow-up revealed that the patient wants to have the device programmed to off and possibly explanted. Neurologist is considering programming the device to off.

Event Description
Reporter indicated that vns pt had experienced an increase in seizures since stimulation was initital. It was reported that pre-vns implant, the pt had one seizure per year. The pt has had approximately one seizure per week since initiation of vns therapy and that there had been no recent changes to their drug regimen. Further follow-up revealed that treating neurologist plans to increase vns settings and possibly decrease anti-epileptic medications. Neurologist indicated that the relationship between the vns therapy system and the reported event was unknown. The pt is still with increased seizures.

Event Description
Further follow-up revealed that the pt has been seizure free for approximately 4 months. Neurologist indicated that the pt has likey experienced greater benefits from vns therapy than the pt realizes. The cause of the reported increased seizures in unknown due to conflicting information from the pt and neurologist.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=508838



Title: Re: Increase in seizures
Post by: dennis100 on November 28, 2011, 03:49:03 AM
Model Number 102
Event Date 12/15/2003
Event Type Injury Patient Outcome Life Threatening;
Manufacturer Narrative
Pt's neurologist indicated that the pt has not been seen for approximately three months and that no complaints or concerns were expressed at last office visit. The pt has not contacted their neurologist's office regarding the event and does not currently have an appointment scheduled. 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 vns pt has experienced an increase in grand mal seizures since implant and that they have never been able to feel stiumlation. It was reported that the pt experienced one grand mal seizure per year pre-vns implant, but that they recently had two grand mal seizures in one day. The pt does not have auras before a seizure, but uses the magnet to initiate magnet mode stimulation when they begin having "little jerks". It was reported that the little jerks are less since vns implant. The pt has reportedly never felt normal mode or magnet mode stimulation and plans to follow-up with their neurologist.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=508889



Title: Re: Increase in seizures
Post by: dennis100 on November 28, 2011, 03:53:05 AM
Model Number 102
Event Date 10/01/2003
Event Type Injury Patient Outcome Life Threatening;
Manufacturer Narrative
Report is incomplete because no response has been received to manufacturer's requests for additional info from treating neurologist. The following dates are estimated. Only the month/year is known: b. 3, date of event.

Event Description
Reporter indicated that pt's seizures have gotten more frequent and more severe since implant. It was reported that the pt goes through periods where seizures are smaller or lighter and at other times they are a lot harder and last longer than normal. The pt recently fell out of bed during a seizure. There have reportedly been no recent medication changes.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=508853



Title: Re: Increase in seizures
Post by: dennis100 on November 28, 2011, 03:53:49 AM
Model Number 102
Event Date 01/01/2003
Event Type Injury Patient Outcome Life Threatening;
Manufacturer Narrative
Report is incomplete due to the anonymous nature of the reported event. No preponse has been received to manufacturer's request for additional information from initial reporter. The following dates are estimated. Only the year is known; b. 3, date of event.

Event Description
Reporter indicated that vns pt has experienced an increase in seizures and that their seizure types have changed since implant. It was reported that the pt now experiences nocturnal seizures, usually about one to one-and-one-half hours into their sleep pattern. The nocturnal seizures reportedly occur sometimes when the pt goes to bed and sometimes just before they full awaken. The pt has also experienced another type of tremor which appears to be the start of a generalized seizure but then stops. The tremor lasts from two to five seconds.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=508847



Title: Re: Increase in seizures
Post by: dennis100 on November 28, 2011, 03:54:34 AM
Model Number 101
Event Date 11/01/2003
Event Type Injury Patient Outcome Life Threatening;
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 patient has experienced an increase in seizures over the past year with more of a drastic change in the last two months. It was reported that the increase was an increase in previous efficacy experienced with the vns therapy. Further follow-up revealed that the pt began to experience episodes of status epilepticus after a trial of acth (adrenocorticotrophic hormone). Treating neurologist indicated that the patient's overall health condition was not worsening. Device diagnostic testing was within normal limits, indicating proper device function.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=510180



Title: Re: Increase in seizures
Post by: dennis100 on November 28, 2011, 03:55:30 AM
Model Number 100
Event Date 01/05/2004
Event Type Injury Patient Outcome Life Threatening; Hospitalization Required Intervention
Manufacturer Narrative
Report is incomplete because the pt reportedly moved to a different state one year ago and has not seen a new neurologist since relocating. No response has been received to mfr's requested for additional info from last known neurologist.

Event Description
Reporter indicated that vns pt was experiencing a life-threatening increase in seizures. Treating physicians believe that the pt's device has reached end of service. Further follow-up revealed that the pt was seen at local hosp at which time neurologist adjusted device settings and recommended that pt make an appointment for follow-up to schedule ncp system replacement.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=510059



Title: Re: Increase in seizures
Post by: dennis100 on November 28, 2011, 03:56:00 AM
Model Number 102
Event Date 01/01/2003
Event Type Injury Patient Outcome Life Threatening;
Event Description
Reporter indicated that vns pt has experienced an increase in seizure activity since implant. Treating neurologist indicated that the pt was frustrated because pt felt that the vns therapy was not working. Neurologist indicated that the pt has "good" months and "bad" months but that he did not believe that the pt had experienced an increase in seizures with the vns therapy. No intervention has been taken and none is planned at this time.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=511294



Title: Re: Increase in seizures
Post by: dennis100 on November 28, 2011, 03:56:40 AM
Event Type Malfunction
Event Description
Vns pt is planning to have device replaced because it is not working.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=523627



Title: Re: Increase in seizures
Post by: dennis100 on November 28, 2011, 03:57:40 AM
Model Number 101
Event Date 12/01/2003
Event Type Injury Patient Outcome Life Threatening;
Manufacturer Narrative
The following dates are estimated. Only the month/year is known: b. 3. Date of event.

Event Description
Reporter indicated that vns pt experienced an increase in seizures following an increase in programmed parameters. The pt reportedly went 2 1/2 months with no seizures and then experienced 3 seizures in 4 weeks time prior to the increase in programmed parameters. The pt reportedly experienced 7-10 seizures during a 3-week period following the increase in programmed parameters.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=511453



Title: Re: Increase in seizures
Post by: dennis100 on November 28, 2011, 04:01:45 AM
Model Number 302-20
Event Date 04/28/2003
Event Type Malfunction
Manufacturer Narrative
H. 6. Ncp system labeling states that the helical electrodes and anchor tether should be coiled around the nerve, beginning with the electrode that is farthest from the lead bifurcation (with green suture embedded in the helical material). This electrode should be nearest (proximal to) the pt's lead. To maximize system performance and minimize possible mechanical damage to the nerve or lead, pay careful attention to electrode placement. 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
Rptr indicated pt's lead was implanted in an inverted configuration. The pt was having good response to the vns therapy until such time that their family member was made aware of the inverted lead position. Since becoming aware of the inverted lead position, the pt's family member claims that the pt is not getting seizure control with the vns therapy.The implanting surgeon was inadequately trained and the vns labeling is inadequate.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=523475


Title: Re: Increase in seizures
Post by: dennis100 on November 28, 2011, 04:08:08 AM
Model Number 300-20
Event Date 06/17/2002
Event Type Malfunction
Manufacturer Narrative
H. 6. Ncp system labeling states that the helical electrodes and anchor tether should be colled around the nerve, beginning with the electrode that is farthest from the lead bifurcation (with green suture embedded in the helical material). This electrode should be nearest (proximal to) the pt's head. To maximize system performance and minimize possible mechanical damage to the nerve or lead, pay careful attention to electrode placement. 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 adolesecents with partial onset seizures that are refractory to antiepileptic medications.

Event Description
Pt's lead was implanted in an inverted configuration. The pt was experiencing seizure control with the vns therapy, but then later reported that the pt was not experiencing seizure control with the vns therapy. The implanting surgeon was inadequately trained and the vns labeling is inadequate. Further follow-up revealed that the pt's lead may not be implanted in the inverted configuration, but this has not yet been confirmed.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=523465


Title: Re: Increase in seizures
Post by: dennis100 on November 28, 2011, 04:09:24 AM
Event Date 01/01/2004
Event Type Injury
Manufacturer Narrative
Report is incomplete because no response has been received to manufacturer's request for additional info from initial reporter. The following dates are estimated. Only the month/year is known: b. 3, date of event. D. 7, implant date.

Event Description
Reporter indicated that vns pt has experienced an increase in seizures. It was reported that the pt experienced some seizure control after vns implant, but that the seizures were worse again after a period of time. There have reportedly been many changes to device settings along with several medication changes. The pt reports that recently, when they raise their arms in an effort to give someone a hug, the motion seems to trigger seizures.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=511852


Title: Re: Increase in seizures
Post by: dennis100 on November 28, 2011, 04:10:31 AM
Model Number 102
Event Date 01/01/2004
Event Type Injury
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 was experiencing "hard vibrations" and an increase in drop attacks. It was reported that the pt's device is implanted in their back instead of in the recommended position just below the clavicle in the left upper chest. The pt is feeling the vibrations in the left side of their back between the axilla and the rib cage area and is reportedly experiencing 5 to 6 drop attacks per day. The pt was referred to implanting neurosurgeon who indicated that the pulse generator was in an excellent position on the pt's back and that their incisions had healed well. Neurosurgeon believes that the vibrations are a response of some kind of pain stimulus that seem to cause some sort of spasm from the pain and discomfort. Neurosurgeon recommended a reduction in stimulation intensity to see if that would lessen the discomfort and the reaction to it. Neurosurgeon does not believe that the pt's problems are related to surgical placement of the device and indicated that the pt's condition was stable. No intervention was taken and none is planned. Device diagnostic testing was within normal limits, indicating proper device function.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=511930



Title: Re: Increase in seizures
Post by: dennis100 on November 28, 2011, 04:11:41 AM
Model Number 300-20
Event Type Malfunction
Manufacturer Narrative
H. 6. Review of manufacturing records for both the pulse generator and the bipolar lead revealed no anomalies that would adversely effect device performance. Review of x-rays revealed that lead connector pins did not appear to be fully inserted into the generator header and that there were two area near the strain relief loop where the lead wire may be compromised.

Event Description
Reporter indicated that device diagnostic testing at office visit resulted in high lead impedance reading (dc-dc code 7 and limit), indicating possible device malfunction. The elective replacement indicator was no, indicating that the generator had not yet reached end of service. The pt had not suffered any recent injury or trauma that may have damaged the ncp system. The pt was able to feel stimulation, but had noticed an increase in seizure activity. The pt has had 14 seizures in the past 25 days which is an increase above previous efficacy obtained with the vns therapy but not an increase above pre-vns baseline. It was reported that the pt's seizures are now lasting longer and that the pt has a longer post-ictal period. The pt feels pain in the left neck area that is somewhat relieved when pt turns their head toward the right. Review of x-rays revealed that the lead connector pins did not appear to be fully inserted into the generator header and that there were two areas near the strain relief loop where the lead wire may be compromised. Revision surgery is planned. Due to the pain, the pt's device was programmed to off pending revision surgery.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=525869



Title: Re: Increase in seizures
Post by: dennis100 on November 28, 2011, 04:13:25 AM
Model Number 101
Event Date 01/22/2004
Event Type Injury Patient Outcome Life Threatening;
Manufacturer Narrative
Report is incomplete because no response has been received to manufacturer's request for additional info from treating neurologist.

Event Description
Reporter indicated that vns pt was experiencing an increase in grand mal seizures. It was reported that the pt did not normally have grand mal seizures, but that there had been an increase in this seizure type over the past 2 or 3 months and that the pt experienced 6 grand mal seizures in one day.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=512355



Title: Re: Increase in seizures
Post by: dennis100 on November 28, 2011, 04:15:11 AM
Model Number 100
Event Date 08/04/1999
Event Type Injury Patient Outcome Life Threatening;
Manufacturer Narrative
Report is incomplete because no response has been received to manufacturer's request for additional info from treating neurologist. H. 6. : the vns therapy system is indicated for use as an adjunctive therapy in reducing the frequency of seizures in adults and adolescents over 12 years of age 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 over 12 years of age with partial onset seizures that are refractory to antiepileptic medications.

Event Description
In the process of contacting the pt to notify them that their device may be nearing end of service, it was discovered that the vns therapy has not helped the pt at all and that the pt has fewer seizure-free days since vns implant. It was reported that pre-vns, the pt would have approx 8 seizure-free days after a bad night of seizures. Since implant, the pt now has only 3 or 4 seizure-free days after a bad night of seizures.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=512349



Title: Re: Increase in seizures
Post by: dennis100 on November 28, 2011, 04:15:47 AM
Model Number 102R
Event Date 05/25/2004
Event Type Injury Patient Outcome Life Threatening; Required Intervention
Event Description
Reporter indicated that pt has experienced an increase in seizures since generator replacement surgery. It was reported that prior to generator replacement surgery, the pt's device was programmed to highest output current settiing (3. 5ma). After generator replacement surgery, the pt's device was programmed to an output current setting approximately 50% lower than their original device was set to. Programmed output current of the new generator has been ramped up on a daily basis in an attempt to get back to the previously prescribed setting of 3. 5ma. The pt has also been treated with diastat during the period of increased seizure activity and now experiences seizure clusters with approximately 70 magnet activations during a 24-hour period. Further follow-up revealed that the pt was experiencing good seizure control on current device settings (2. 0ma output current), but the paitent was experiencing abdominal quivering and an elevated keppra level (from 50 to 90 in one week). In spite of a decrease in keppra dosage.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=531640


Title: Re: Increase in seizures
Post by: dennis100 on November 28, 2011, 04:16:32 AM
Model Number 102
Event Type Injury
Patient Outcome Required Intervention;
Event Description
Reporter indicated that pt has experienced continuous seizures. Treating neurologist also indicated that the pt has done well with vns therapy with personality improvements; however, the pt's seizures have changed in characteristic. Treating neurologist plans to continue to change device settings in order to obtain better seizure control.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=530313


Title: Re: Increase in seizures
Post by: dennis100 on November 28, 2011, 04:17:18 AM
Model Number 101
Event Date 01/01/2004
Event Type Malfunction
Event Description
Patient is no longer able to feel magnet mode stimulation and he has experienced increase in seizures. Magnet mode output current is normally set to 1. 75ma. But when treating neurologist increased magnet mode output current to 2. 5ma, the patient still could not feel stimulation. It is unknow at this time whether the device is functionng properly. Review of x-rays revelaed that the electrodes appear to be placed lower on the nerve than normal; however, this cannot be confirmed to lead to the reported event. No other anomalies were identified with the ncp system.

Manufacturer Narrative
Review of the manufacturing records for both the pulse generator and the bipolar lead revealed no anomalies that would adversely effect device performance.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=596462



Title: Re: Increase in seizures
Post by: dennis100 on November 28, 2011, 04:18:55 AM
Model Number 102R
Event Date 04/01/2004
Event Type Injury Patient Outcome Life Threatening;
Manufacturer Narrative
Report is incomplete because attempts to obtain additional information from physician have been unsuccessful to date.

Event Description
Reporter indicated that the pt had an increase in seizures. The pt was doing well with vns therapy. However, within the last two weeks, the pt has experienced an increase in seizures (approximately 6 seizures). It was also reported that the pt was not experiencing any unusual stress and the device appears to be stimulating as programmed. Prior to these events, the pt's seizure frequency was about one every 3 months. It is unknown if the recent seizure frequency is above the pt's pre-vns baseline frequency.


http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=529257


Title: Re: Increase in seizures
Post by: dennis100 on November 28, 2011, 04:20:14 AM
Model Number 102
Event Date 01/01/2004
Event Type Injury Patient Outcome Life Threatening;
Manufacturer Narrative
Report is incomplete because no response has been received to manufacturer's request for additional information from treating neurologist. H. 6. Review of manufacturing records for both the pulse generator and the bipolar lead revealed no anomalies that would adversely effect device performance.

Event Description
Vns pt believed that their device may not be working properly as pt had recently experienced a flurry of seizures. Programmed device settings had not been changed for approx 6 months with exception of recent adjustment to off time. Off time had recently been reduced from 5 minutes to 3 minutes. Device diagnostic testing was within normal limits, indicating proper device function. The elective replacement indicator was no, indicating that the generator had not reached end of service. Treating neurologist plans to monitor the pt and adjust medications. Investigation to date has been unable to determine whether the flurry of seizures is an increase above the pt's pre-vns baseline seizure frequency.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=528240



Title: Re: Increase in seizures
Post by: dennis100 on November 28, 2011, 04:21:11 AM
Model Number 300-20
Event Type Malfunction
Manufacturer Narrative
Review of manufacturing records for the concomitant device revealed no anomalies that would adversely effect device performance.

Event Description
Device diagnostic testing at office visit resulted in high lead impedance reading (dc-dc code 7 and limit). Indicating possible device malfunction. It was reported that the patient had experienced an increase in seizure activity for the past six weeks and had even experienced a few grand mal seizures, a seizure type that patient had not experienced for some time. The patient's seizures had not increased above pre-vns baseline frequency. The patient no longer feels stimulator. There had been no recent injury or trauma that may have damaged the vns therapy system.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=586762



Title: Re: Increase in seizures
Post by: dennis100 on November 28, 2011, 04:22:09 AM
Model Number 102
Event Date 04/01/2004
Event Type Injury Patient Outcome Life Threatening;
Manufacturer Narrative
Report is incomplete because no response has been received to mfr's request for additional info from treating neurologist. H. 6. Vns therapy system labeling states that the safety and efficacy of this therapy have been not been systematically established for uses in pts with history or previous therapeutic brain sugery.

Event Description
Reporter indicated that vns pt experienced an increase in seizures after an increase in programmed device output current. It was reported that stimulation was initiated at time of implant at 0. 25ma normal mode output current and that introperative device diagnostic testing was within normal limits. At follow-up office visit, programmed device output current was increased to 0. 75ma, after which the pt exprerienced 21-22 seizures in a 24-hour period. It was reported that this was more seizures than the pt ever had in one day. After programmed device output current was increased to 1. 0ma, the pt reportedly had no further seizure activity.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=525927



Title: Re: Increase in seizures
Post by: dennis100 on November 28, 2011, 04:22:49 AM
Model Number 100
Event Date 10/01/1998
Event Type Injury Patient Outcome Life Threatening; Hospitalization Required Intervention
Event Description
In the process of contacting the pt's neurosurgeon to notify him that the pt's device may be nearing end of service, it was discovered that the pt's device had been programmed to off and was later explanted due to an increase in seizure frequency and severity with the vns therapy. With the vns therapy, the pt at times experienced 30 or more seizures over a two-hour period. Additionally, the pt was seen in hosp e. R. Approximately 6 months post-implant due to a severe flurry of seizures. It was reported that the pt's usual baseline seizure frequency was 4-5 seizures each day and 15-20 seizures each night. The pt reportedly had an excellent response to the vns therapy after initial parameter adjustments, with seizures stopping completely for a few days. The seizures then returned and the pt could no longer feel the stimulation. Device diagnostic testing was within normal limits, indicating proper device function. Cortical resection prior to programming the vns to off along with tapered reduction of gabitril dosage resulted in complete seizure control for the pt. Only the pulse generator was explanted. The bipolar lead was left in situ.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=525507



Title: Re: Increase in seizures
Post by: dennis100 on November 28, 2011, 04:23:38 AM
Model Number 102
Event Date 01/01/2004
Event Type Injury Patient Outcome Life Threatening;
Event Description
Reporter indicated that vns pt's seizures had returned to pre-vns baseline frequency. It was reported that the pt was seizure-free for over a year immediately after vns implant, but that treating neurologist began reducing the pt's medications and increasing programmed parameters. At recent office visit, vns settings were again increased, after which the pt immediately experienced a severe grand mal seizure in the office. The pt's family member believes that vns settings have been programmed to a level that is too high.

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 refractroy 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.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=525547



Title: Re: Increase in seizures
Post by: dennis100 on November 28, 2011, 04:24:20 AM
Model Number 300-20
Event Date 09/01/2002
Event Type Malfunction
Event Description
Reporter indicated that the device diagnostic testing at office visit resulted in high lead impedance reading (dc-dc code 7 and limit), indicating possible device malfunction. The elective replacement indicator was no, indicating that the generator had not reached end of service. It was reported that the pt has experienced an increase in seizure activity since undergoing generator replacement surgery approximately 18 months prior. Intraoperative device diagnostic testing at the time of generator replacement surgery was within normal limits, indicating proper device function at that time. It is unk whether the pt feels stimulation as pt is non-communicative. X-rays reviewed by treating neurologist did not reveal any obvious discontinuities in the ncp system. The pt is scheduled for revision surgery. Lead break is suspected.

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 affect device performance.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=561273



Title: Re: Increase in seizures
Post by: dennis100 on November 28, 2011, 04:25:19 AM
Model Number 102
Event Date 03/01/2004
Event Type Injury Patient Outcome Life Threatening;
Manufacturer Narrative
H. 6. Vns therapy system labeling states that although cyberonics recommends adjusting output current as necessary, there are no controlled data at this time to indicate that higher current levels are associated with better efficacy. Patients whose seizures are well controlled at follow up should not have their settings changed unless they experience uncomfortable side effects. There is no proven correlation at present between high output current (m amps) and device effectiveness, nor is there a standard treatment level that needs to be achieved during treatment ramping.

Event Description
Reporter indicated that vns patient experienced an increase in seizures above pre-vns baseline frequency that apparently coincided with increase in device normal mode output current. It was reported that the patient experienced 3-4 seizures per month before vns implant. When normal mode output current was sent to 1. 0ma, the patient experienced only 1 seizure during that month. Two months later, normal mode output current was increased to 1. 75ma and the patient reportedly experienced 9 seizures that month. There have been no medication changes that may have contributed to the seizure increase and blood work was normal for aed levels. Patient plans to follow-up with neurologist to discuss reducing normal mode output current back to level where good seizure control was apparently achieved.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=524128



Title: Re: Increase in seizures
Post by: dennis100 on November 28, 2011, 04:26:13 AM
Model Number 300-20
Event Type Malfunction
Event Description
A portion of the explanted lead assembly was returned to manufacturer for analysis. All but the electrode bifurcation portion of the lead was returned. The condition of the returned portion of the lead assembly is consistent with conditions that typically exist following an explant procedure. The lead pin showed evidence of a proper mechanical and electrical connection. Incisions in the outer tubing were noted during visual inspection; however, no obvious damage to either the inner tubing or to the lead coil wires was noted at these locations. Dry body fluids were noted at these locations, but it is unknown whether this condition existed during the implant life of the lead or if this condition is a result of the explant procedure. Scanning electron microscopy was performed at these locations and revealed no pitting or electro-plating conditions. Investigation to date hasbeen unable to determine the cause of the reportedhigh lead impedance test result.

Manufacturer Narrative
H6. Review of mfg records revealed no anomalies that would adversely effect device performance. 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.

Event Description
Reporter indicated that device diagnostic testing at office visit resulted in high lead impedance reading (dc-dc code 7 and limit), indicating possible device malfunction. The elective replacement indicator was no, indicating that the generator had not reached end of service. The pt has reportedly experienced a recent increase in seizure activity. Review of x-rays by treating neurologist was inconclusive in determining whether there were any discontinuities in the ncp system. The pt had not suffered any recent injury or trauma that may have damaged ncp system. The pt is scheduled for revision surgery.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=558911



Title: Re: Increase in seizures
Post by: dennis100 on November 28, 2011, 04:27:37 AM
Model Number 102
Event Date 04/15/2004
Event Type Injury Patient Outcome Life Threatening; Hospitalization
Manufacturer Narrative
Report is incomplete because no response has been received to manufacturer's request for additional info from treating neurologist.

Event Description
Reporter indicated that vns pt was air-lifted to hospital because pt experienced 27 seizures within a 24-hour period. The seizures were described as a breakthrough cluster. The pt's pre-vns seizure frequency is documented as being between 0 and 4 generalized seizures per month.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=525388


Title: Re: Increase in seizures
Post by: dennis100 on November 28, 2011, 12:47:53 PM
Model Number 102
Event Date 03/04/2004
Event Type Injury Patient Outcome Life Threatening;

Manufacturer Narrative
H. 6. Vns therapy system labeling states that the safety and efficacy of this therapy have not been systematically established for use in pts with history or previous therapeutic brain surgery.

Event Description
Pt's seizures have increased in severity since vns implant. It was reported that the pt's seizures last from 5-20 secs and that the pt experiences a second seizure when they use the magnet. The pt reports that if they do not use the magnet, then a second seizure does not occur. The pt has not been seen by neurologist for 2-3 mos because it is too far a drive and neither they nor their spouse drive. Additionally, the pt indicated that they have been changing their own medication regimen and that "they knew more about the medications than the dr. " the pt was scheduled for a follow-up appointment with their neurologist approx four mos ago, but did not keep that appointment. The pt has since scheduled another follow-up appointment with their neurologist.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=547111



Title: Re: Increase in seizures
Post by: dennis100 on November 28, 2011, 12:48:30 PM
Model Number 102
Event Date 03/29/2004
Event Type Injury Patient Outcome Life Threatening;
Manufacturer Narrative
Report is incomplete because no response has been received to mfr's requests for add'l info from treating neurologist (via fax x2). This event is currently under investigation.

Event Description
The pt has experienced an increase in seizure frequency since vns therapy system implant. It was also reported that the pt's seizure strength has decreased with vns therapy and that the magnets are effective in stopping the pt's seizures. It is unk if the increase in seizures is above the pt's pre-vns baseline frequency.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=547115



Title: Re: Increase in seizures
Post by: dennis100 on November 28, 2011, 12:49:13 PM
Model Number 102
Event Date 01/01/2004
Event Type Injury Patient Outcome Life Threatening;
Event Description
Vns pt has been experiencing an increase in seizures. Rptr stated that pt's seizures have been increasing with each programming change. It was reported that pre-vns, the pt had 8-9 seizures per month and that they are now experiencing seizures on a daily basis. Pt's family member reported that use of the magnet does not seem to stop or shorten seizures or help with recovery time of seizures. Initially physician reported that he would be decreasing the device off time from 5 mins to 3 mins. Physician stated that the reported event is not related to the vns.

Manufacturer Narrative
This event is currently under investigation.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=547118



Title: Re: Increase in seizures
Post by: dennis100 on November 28, 2011, 12:50:18 PM
Model Number 100
Event Date 07/01/2003
Event Type Injury Patient Outcome Life Threatening; Hospitalization Required Intervention
Manufacturer Narrative
This event is currently under investigation. The following dates are estimated. Only the month/year is known: b. 3, date of event.

Event Description
In the process of contacting the pt to notify them that their device may be nearing end of service, it was discovered that the pt experienced an increase in seizure activity above pre-vns baseline frequency. Based on the time frame of the reported increase in seizure activity, it does not appear that the increase was a result of generator end of service. Device diagnostic testing at that time was within normal limits, indicating proper device function. Physician's notes from that office visit do not contain info regarding whether the elective replacement indicator was yes or no. Additionally, it was reported that there were device parameter changes and medication changes around the time of the increase in seizure activity. The pt has since undergone generator replacement surgery and is reportedly doing well. Review of manufacturing records for both the pulse generator and the bipolar lead revealed no anomalies that would adversely effect device performance.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=547303



Title: Re: Increase in seizures
Post by: dennis100 on November 28, 2011, 12:50:55 PM
Model Number 302-30
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. 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 device diagnostic testing at office visit resulted in high lead impedance (dc-dc code unk), indicating possible device malfunction. It was also reported that the pt experienced an increase in seizures. It is unk if the increase in seizures is above the pt's pre-vns baseline frequency. Revision surgery was performed. During revision surgery, neurosurgeon noted that the generator setscrew was stripped. Both the pulse generator and bipolar lead were then replaced, it is likely that the high lead impedance reading was a result of the negative electrode not being attached to the pt's vagus nerve.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=612165



Title: Re: Increase in seizures
Post by: dennis100 on November 28, 2011, 12:51:24 PM
Model Number 102
Event Date 04/24/2003
Event Type Injury Patient Outcome Life Threatening; Required Intervention
Manufacturer Narrative
Report is incomplete because no response has been received to manufactuer's requestes for additional information from treating neurologist. 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 patient has experienced an increase in seizure activity since vns implant and that the patient's medications have subsequently been increased. The patient experienced 5-10 seizures per month pre-vns. Investigation to date has been unable to determine the severity of the reported seizure increase.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=479997


Title: Re: Increase in seizures
Post by: dennis100 on November 28, 2011, 12:52:59 PM
Model Number 100
Event Date 01/01/2003
Event Type Injury Patient Outcome Life Threatening; Required Intervention
Manufacturer Narrative
Report is incomplete because no response has been received to manufacturer's requests for additional info from treating neurologist.

Event Description
Reporter indicated that vns pt had experienced five status seizures in the past six months, which was more than the pt had previously experienced throughout an entire year. Normal mode output current had reportedly been programmed to off in preparation for an mri as the pt was being considered for brain surgery. It was reported that the pt had not experienced any seizure improvement with the vns therapy. Treating neurologist reportedly plans to leave the device normal mode output current programmed to off for two months to see how the pt does.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=480077


Title: Re: Increase in seizures
Post by: dennis100 on November 28, 2011, 12:53:43 PM
Model Number 102
 Event Date 02/18/2003
Event Type Injury Patient Outcome Life Threatening;
Manufacturer Narrative
Report is incomplete because no response has been received to manufacturer's requests for additional info from treating neurologist. The pt is scheduled for a follow-up visit with neurologist in the near future and the neurologist has indicated that he will respond to the request for info after he sees the pt.

Event Description
Reporter indicated that pt has experienced an increase in seizures since vns implant. It was reported that the pt's seizures were reportedly increasing before vns implant. The pt had been taking lamictal for approximately six years and had recently been reduced for 500mg/day to 400mg/day. It was reported that the pt's seizure patterns have changed in the past and that this seizure increase may just be another change in the seizure pattern. Investigation to date has unable to determine the relationship between the seizure increase and the vns.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=479088



Title: Re: Increase in seizures
Post by: dennis100 on November 28, 2011, 12:54:42 PM
Model Number 102
Event Date 07/02/2003
Event Type Injury Patient Outcome Life Threatening; Required Intervention
Event Description
Reporter indicated that vns patient has experienced an increase in seizures since stimulation was initiated. It was reported that before vns therapy, the patient had 7 - 8 petit mal seizures per month and that post therapy, patient has 3 - 4 petit mal seizures per day. Treating neurologist indicated that the patient had requested a reduction in programmed parameters due to the increase in seizures. Neurologist indicated that the increase was possibly related to the vns therapy.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=478603


Title: Re: Increase in seizures
Post by: dennis100 on November 28, 2011, 12:55:55 PM
Model Number 100
Event Date 01/01/2000
Event Type Injury Patient Outcome Life Threatening; Required Intervention
Manufacturer Narrative
Report is incomplete because no response has been received to manufacturer's requests for additional information from treating neurologist.

Event Description
In the process of contacting the patient to notify patient that the device may be nearing end of service, it was discovered that the patient's device had been programmed to off approximately two years prior due to an increase in seizures and has been off ever since. It was reported that the patient experienced an increase in seizures following vns implant. The patient's seizures have reportedly been difficult to treat and patient still has 100-150 seizures per day. Patient's mother is considering having the device explanted in the future.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=478612

Model Number 101
Event Type Injury Patient Outcome Life Threatening;
Manufacturer Narrative
Report is incomplete because no response has been received to manufacturer's requests for additional information from treating neurologist. Neurologist is moving to a new office and indicated that patient reocrds are currently packed in boxes and not readily accessible.

Event Description
Reporter indicated that the patient had experienced drop attacks. It was reported that the patient's seizure type changed from tonic clonic to atonic seizures. Physician described the atonic seizures as drop attacks. It was stated that the change in seizure type corresponded to an increase in duty cycle.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=476426



Title: Re: Increase in seizures
Post by: dennis100 on November 28, 2011, 12:56:39 PM
Model Number 300-20
Event Type Malfunction
Event Description
Reporter indicated that vns patient was scheduled for revision surgery due to suspected device malfunction with an increase in seizure activity. Device diagnostic testing at office visit resulted in high lead impedance reading (dc-dc code 7 and limit), indicating possible device malfunction. It was reported that the patient was still able to feel stimulation at this office visit. Device diagnostic testing at previous office visit, approximately 1 1/2 months prior, yielded the same results. The patient reported ten seizure-free days following a parameter adjustment at previous office visit. The patient reportedly then had an increase in seizures between the two office visits and was started on keppra to which patient responded well. The patient's seizures had reportedly improved somewhat after starting the new medication. It was reported that the patient has a remarkable amount of seizures and that it is not known whether the increase in seizures was above the paient's pre-vns baseline frequency. Prior to the seizure increase, the patient had complex partial and simple partial seizures. With the seizure increase, the patient had more generalized tonic clonic seizures. It was reported that the patient's overall health condition is not worsening. The elective replacement indicator was no at both office visits, indicating that the generator had not reached end of service. Treating neurologist indicated that the generator may be nearing end of service due to length of time that it has been implanted. If the generator is not nearing end of service, then it is possible that fibrosis may be the cause of the high lead impedance readings due to the length of time that the lead has been implanted. Investigation to date has been unable to determine whether or not device malfunction is the cause of the high lead impedance condition.

Manufacturer Narrative
H. 6. Method: device mfg records were reviewed. H. 6. Results: review of manufacturing records for both the pulse generator and the bipolar lead revealed no anomalies that would adversely effect device performance.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=478366



Title: Re: Increase in seizures
Post by: dennis100 on November 28, 2011, 12:57:10 PM
Event Date 07/01/2003
Event Type Malfunction
Manufacturer Narrative
Report is incomplete because no response has been received to manufacturer's requests for additional info from treating neurologist. Vns therapy system labeling lists dyspnea (difficulty breathing, shortness of breath) as a potential adverse event possibly associated with surgery or stimulation.

Event Description
Reporter indicated that vns pt has been experiencing as many as 6 seizures a day after being seizure free for approx 15 weeks. It was reported that the increase in seizures is above the pt's pre-vns baseline seizure frequency. The magnet is reportedly no longer effective in stopping the pt's seizures. The physician checked the magnet results and found that the magnet is functioning. The pt reportedly experiences difficulty breathing and gets "worn out" following device parameter changes.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=476255


Title: Re: Increase in seizures
Post by: dennis100 on November 28, 2011, 12:57:52 PM
Model Number 100
Event Date 01/01/2003
Event Type Injury Patient Outcome Life Threatening; Required Intervention
Manufacturer Narrative
No response has been received to manufacturer's requests for additional info from treating neurologist.

Event Description
The pt's seizure activity has become worse and that it was never improved with vns therapy. The pt's device is still implanted; however, it has been deactivated.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=474996


Title: Re: Increase in seizures
Post by: dennis100 on November 28, 2011, 12:58:33 PM
Model Number 102
Event Date 06/01/2003
Event Type Injury Patient Outcome Life Threatening; Hospitalization Required Intervention
Event Description
The pt has been experiencing an increase in seizures. It is unk whether the increase in seizure is above the pt's pre-vns baseline. It was reported that previously the pt did not experience seizures everyday, but that now they experience many seizure per day. The pt will be admitted to the hospital to undergo eeg's and device parameter increase. Further follow-up revealed that while the device was set to very low settings (. 25ma), the pt went into status and was admitted to the hospital where they received stitches.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=475032



Title: Re: Increase in seizures
Post by: dennis100 on November 28, 2011, 12:59:31 PM
Model Number 102
Event Date 12/11/2002
Event Type Injury Patient Outcome Life Threatening; Hospitalization Required Intervention
Manufacturer Narrative
Report is incomplete because no response has been received to manufacturer's request for additional information from treating neurologist.

Event Description
Vns patient's seizures are worse following vns implant. It was reported that the patient has experienced an increase in the number of seizures. The patient reportedly had a recent seizure during which they blacked-out and fell. The patient subsequently underwent ear surgery because they damaged their ear during the fall. The patient reported that they did have black-outs prior to vns implant.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=473853



Title: Re: Increase in seizures
Post by: dennis100 on November 28, 2011, 01:00:17 PM
Model Number 102
Event Date 06/10/2003
Event Type Injury Patient Outcome Life Threatening; Hospitalization Required Intervention
Event Description
Reporter indicated that vns pt experienced a grand mal seizure that resulted in hospitalization. It was reported that the pt experienced grand mal seizures pre-vns implant, but that their recent seizure was more violet and had a longer postictal period. Pre-vns, the pt's grand mal postictal period would be 20-30 minutes. With the recent grand mal seizure, the postictal period was 12 hours. Medications were reportedly increased during the pt's hosp stay. The pt is scheduled for follow-up with their neurologist.

Manufacturer Narrative
Report is incomplete because no response has been received to mfr's requests for add'l info from treating neurologist. H. 6. : device programming history was reviewed. H. 6. : review of device programming history did not reveal any abnormalities. No device diagnostic test results were available for review.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=471200



Title: Re: Increase in seizures
Post by: dennis100 on November 28, 2011, 01:01:03 PM
Model Number 102
Event Date 04/01/2003
Event Type Injury Patient Outcome Hospitalization; Required Intervention
Event Description
Reporter indicated that vns pt has experienced "full body drop seizures" since vns implant. It was reported that the pt had only head drop seizures pre-vns. It was reported that the pt has had 80 "full body drop seizures" since vns implant and that they have subsequently suffered injuries from these seizures (broken collar bone, lacerations on head requiring stitches). There have reportedly been no medication changes during this period, but it was reported that the pt's depakote level was low (68) at recent emergency room visit due to injury suffered from drop seizure. The pt's mother does not feel that the pt's neurologist is aggressive enough with their therapy. The pt's device has been programmed to the lowest normal mode output current setting (0. 25ma) since initiation of stimulation. Treating neurologist indicated that the relationship between the pt's condition and the vns therapy system was unknown. Both the treating neurologist and the pt's parents are considering either explant or programming the device to off permanently.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=471503



Title: Re: Increase in seizures
Post by: dennis100 on November 28, 2011, 01:01:46 PM
Event Description
Reporter indicated that pt has experienced an increase in seizures since vns implant. It was reported that the pt has been having more seizures during the day, but that their nighttime seizure activity had decreased. Investigation to date has been unable to determine the severity of the seizure increase.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=479448



Title: Re: Increase in seizures
Post by: dennis100 on November 28, 2011, 01:02:52 PM
Model Number 101
Event Date 07/01/2003
Event Type Injury Patient Outcome Life Threatening; Hospitalization Required Intervention
Manufacturer Narrative
H6: 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 had been experiencing an increase in seizures and was currently hospitalized for status epilepticus. The pt's generator had been programmed to rapid cycling, but the elective replacement indicator was no, indicating that the generator had not reached end of service. The pt underwent generator replacement surgery, but continues to have seizures. There was reportedly no environmental stimuli that may have contributed to the pt's seizure increase. Treating neurologist indicated that the relationship between the reported event and the ncp system was unknown.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=479865








Title: Re: Increase in seizures
Post by: dennis100 on November 29, 2011, 03:12:33 AM
Model Number 101
Event Date 05/01/2003
Event Type Injury Patient Outcome Life Threatening;
Event Description
Reporter indicated that pt has experienced an increase in seizures since vns therapy was initiated. It was reported that the pt experienced 6-8 seizures per month pre-vns and that after stimulation was initiated, the pt has experienced approx 15 seizures per month.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=493009


Title: Re: Increase in seizures
Post by: dennis100 on November 29, 2011, 03:15:17 AM
Model Number 102
Event Type Malfunction
Manufacturer Narrative
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
Device diagnostic testing at office visit resulted in an elective replacement indicator of yes, indicating possible premature end of service since device had only been implanted for 8 months and had not been programmed to aggressive settings. The pt reportedly feels like seizure frequency had slightly increased, but no noticeable difference. The pt reported that they do not feel stimulation. Treating neurologist plans to monitor the pt.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=493676



Title: Re: Increase in seizures
Post by: dennis100 on November 29, 2011, 03:15:59 AM
Model Number 101
Event Date 09/01/2003
Event Type Injury Patient Outcome Life Threatening; Hospitalization
Manufacturer Narrative
Report is incompleting because no response has been received to manufacturer's request for additional information from treating neurologist.

Event Description
Reporter indicated that vns patient recently experienced 4 severe seizures which required hospitalization and icu care. It was reported that the patient's device settings were increased twice at their first programming visit with their neurologist. The patient reportedly began having seizures that same night and was hospitalized in the icu. The patient is reportedly doing better now and has only had the aforementioned seizures since vns implant. Investigation to date has been unable to determine whether the vns setting increase contributed to the reported event.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=493172



Title: Re: Increase in seizures
Post by: dennis100 on November 29, 2011, 03:16:56 AM
Model Number 102
Event Date 08/01/2003
Event Type Injury Patient Outcome Life Threatening;
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 patient hasn't been able to keep any food down for two days and that the patient had a fever and lots of seizures. Further follow-up revealed that treating neurologists have reportedly stopped increasing the patient's programmed parameters and have added keppra to the patient's drug regimen. The patient's phelbamate dosage has also been reduced, but these changes have reportedly not been effective in regaining seizure control. It was reported that patient's stomach problems seem to be an effect to the valium that patient was given to stop a flurry of seizures. Investigation to date has been unable to determine whether the patient's seizure increase is above the pre-vns baseline frequency.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=493339



Title: Re: Increase in seizures
Post by: dennis100 on November 29, 2011, 03:18:05 AM
Model Number 101
Event Type Injury
Patient Outcome Life Threatening;
Manufacturer Narrative
Report is incompolete because no response has been received to manufacturer's request for additional information from treating physician.

Event Description
Patient has experienced a 20% increase in seizures since vns implant. It was reported that the patient is not able to use magnet to interrupt seizures because seizures begin in right arm which keeps them from swiping the device. Additionally, it was reported that the patient no longer has auras since vns implant.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=491772



Title: Re: Increase in seizures
Post by: dennis100 on November 29, 2011, 03:18:53 AM
Model Number 101
Event Date 08/05/2003
Event Type Injury Patient Outcome Life Threatening; Hospitalization Required Intervention
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 over 12 years of age 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 over 12 years of age with partial onset seizures that are refractory to antiepileptic medications.

Event Description
Reporter indicated that vns pt was hospitalized due to an increase in seizures. The pt was discharged after 5 days. Numerous medication adjustments were made during the pt's hospital stay. Investigation to date has been unable to rule out vns as a contributing factor to the pt's seizure increase. Device diagnostic testing was within normal limits, indicating proper device function. 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=491349



Title: Re: Increase in seizures
Post by: dennis100 on November 29, 2011, 03:19:55 AM
Model Number 102
Event Date 04/01/2003
Event Type Injury Patient Outcome Life Threatening;
Event Description
Further follow-up revealed that there are no plans to program the patient's device back to on. Neurologist indicated that the patient's seizures are now stable. Neurologist reported that it is unknown if the vns therapy system is related to the patient's increase in seizures and that the patient's natural evolution to seizures is a possible cause.

Manufacturer Narrative
Vns therapy system labeling lists vomiting as a potential adverse event possibly associated with surgery or stimulation. The vns therapy system is indicated for use as an adjunctive therapy in reducing the frequency of seizures in adults and adolescents over 12 years of age 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 over 12 years of age with partial onset seizures that are refractory to antiepileptic medications.

Event Description
The vns therapy has seemed to make the patient's seizures worse. Pre-vns, the patient's seizure pattern followed a pattern of good control for 5 to 9 months and then the patient's condition would worsen until they went into status and was hospitalized. With medication changes and hospitalization, the patient would return to another 5 to 9 months of good control. The patient was implanted with the vns "in the middle of a seizure-free time" and they began to have seizures five days after stimulation was initiated. The patient's seizure pattern has not been the same since initiation of stimulation and the patient's family member believes that the vns therapy "somehow messes patient up". It was reported that the patient's condition is improving as device settings have increased but is still having problems. It was also reported that the patient now vomits every couple of weeks which they did not do prior to vns implant.

Event Description
Further follow-up revealed that the patient's device was programmed to off (date unknown).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=491640



Title: Re: Increase in seizures
Post by: dennis100 on November 29, 2011, 03:20:44 AM
Model Number 102
Event Date 01/01/2003
Event Type Injury Patient Outcome Life Threatening; Required Intervention
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 over 12 years of age 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 over 12 years of age with partial onset seizures that are refractory to antiepileptic medications.

Event Description
Reporter indicated that patient has experienced an increase in seizures since vns implant and that they are now having tonic seizures which they did not have pre-vns. Patient's family member used the magnet to temporarily discontinue stimulation and planned to make an appointment with physician the following day.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=489989



Title: Re: Increase in seizures
Post by: dennis100 on November 29, 2011, 03:21:26 AM
Model Number 302-20
Event Date 01/01/2003
Event Type Injury Patient Outcome Life Threatening; Hospitalization Required Intervention
Manufacturer Narrative
Product analysis results will not change the conclusion of the reported event because explanted products are decontaminated prior to return; therefore, microbiological testing is not performed. In the event that the explanted device returned, product analysis result will only be reported if a device malfunction is noted that would be likely to cause a death or serious injury if the malfunction were to recur. Device manufacturing records were reviewed. Vns therapy system labeling lists infection as a potential adverse event possibly associated with surgery. Review of manufacturing records for both the pulse generator and the bipolar lead confirmed sterilization of devices.

Event Description
Reporter indicated that vns patient was explanted due to wound dehiscence, infection and an increase in seizures. It was reported that the patient's incisions never healed properly and that the patient's family member believed that the patient had more seizures after being implanted with the vns. Treating physician indicated that patient had a stitch abscess five months before explant. Local debridement was performed. The patient reportedly developed an infection and was later explanted. The patient's family member indicated that the infection started in the neck and ended up in the chest area as well.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=490234



Title: Re: Increase in seizures
Post by: dennis100 on November 29, 2011, 03:22:19 AM
Model Number 302-20
Event Date 11/22/2002
Event Type Malfunction
Manufacturer Narrative
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
Vns pt underwent revision surgery due to an increase in seizures and a high lead impedance result during device diagnostic testing. During the revision surgery, it was noted that the lead connector pins were loose in the generator header. The lead pins were reconnected to the generator header and subsequent device diagnostic testing was within normal limits. High lead impedance results were initially reported to the manufacturer eight months prior (dc-dc code 6 and ok). Treating neurologist indicated at the time that he believed that the high impedance result was related to the way that the device was implanted. The pt could feel stimulation and was receiving the programmed therapy since the device diagnostic testing did not result in "ok" and not "limit". The pt was reportedly doing fine at that time and no intervention was planned. Revision surgery was later performed when the pt began to experience an increase in seizure activity.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=490264



Title: Re: Increase in seizures
Post by: dennis100 on November 29, 2011, 03:23:06 AM
Model Number 101
Event Type Injury
Patient Outcome Life Threatening;
Event Description
Reporter indicated that patient's family believed that the patient had more seizures with the vns implant. It was initially reported that the patient was explanted due to end of service. Further follow-up revealed that the patient complained of constant pain and that the patient's family believed that patient had more seizures with the vns implant.

Manufacturer Narrative
Concomitant device was returned and analyzed. The condition of the lead was consistent with conditions that exist after the explant procedure. Visual and electrical testing revealed no anomalies on the portion of the lead assembly that was returned. Ncp system labeling states that the safety and efficacy of this therapy have not been systematically established for uses not covered in the "intended use / indications" section of the manual or in patients with history of previous therapeutic brain surgery.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=489083



Title: Re: Increase in seizures
Post by: dennis100 on November 29, 2011, 03:23:56 AM
Model Number 102
Event Date 09/08/2003
Event Type Injury Patient Outcome Life Threatening; Hospitalization Required Intervention
Event Description
Reporter indicated that vns pt was hospitalized for four days due to prolonged seizures. It was reported that the pt was experiencing an increase in seizures and that the device off time was subsequently reduced. Later that same day, the pt was hospitalized for prolonged seizures. Tegretol doseage was increased and iv antiepileptic medications were administered. The pt denied any recent illness, missed medication doses or use of new over-the-counter medications. The pt's tegretol dosage was increased upon discharge from hosp with plans for a follow-up visit with treating neurologist in two weeks time. Device diagnostic testing was within normal limits, indicating proper device function

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=488293


Title: Re: Increase in seizures
Post by: dennis100 on November 29, 2011, 03:24:52 AM
Model Number 101
Event Date 03/25/2003
Event Type Injury Patient Outcome Life Threatening;
Manufacturer Narrative
Report is incomplete because no response has been received to manufacturer's requests for additional information from treating neurologist.

Event Description
Vns patient's seizures had changed in frequency (increased) and type (drop events) since generator replacement surgery. It was reported that treating neurologist is making adjustments to programmed parameters and medications.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=498036



Title: Re: Increase in seizures
Post by: dennis100 on November 29, 2011, 03:25:40 AM
Model Number 101
Event Date 01/01/2000
Event Type Injury Patient Outcome Life Threatening; Required Intervention
Event Description
Rptr indicated that the pt only had seizures at night pre-vns and that they started to have seizures during the day after vns implant. Parameter adjustments did not resolve the issue. Last known neurologist had not seen the pt for over 2 yrs. Further follow-up revealed that the vns therapy seemed to help for the first year and a half, but the pt then developed a seizure pattern of having seizures about every 3 weeks for about 3-5 days straight and then going about 3 weeks with no seizures. The pt's device had recently been programmed to off per the family member's request. The pt's family member reports that since the device was programmed to off, the pt is not having any more seizures.

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 of 12 years of age 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 over 12 years of age with partial onset seizures that are refractory to antiepileptic medications.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=497003



Title: Re: Increase in seizures
Post by: dennis100 on November 29, 2011, 03:26:48 AM
Model Number 102
Event Date 10/01/2003
Event Type Injury Patient Outcome Hospitalization;
Manufacturer Narrative
Report is incomplete because attempt to obtain additional information from physician has been unsucessful to date.

Event Description
The patient was in icu due to seizures. The patient claimed that they no longer feel stimulaton; feels that vns is not working. Diagnostic testing was performed which resulted in a dc dc code of 2 indicating that the system is delivering stimulation. It was also reported that the patient had been "seizure free" prior to this event. The reporter stated that the patient was in the process of being weaned off of seizure medications. The vns device settings were increased and the patient then felt the stimulation.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=495998



Title: Re: Increase in seizures
Post by: dennis100 on November 29, 2011, 03:27:31 AM
Event Date 01/01/2003
Event Type Injury Patient Outcome Hospitalization;
Manufacturer Narrative
Report is incomplete because attempt to obtain additional information from physician has been unsuccessful to date.

Event Description
The patient has been hospitalized twice due to an increase in seizures. It was reported that the patient was having good seizure control after vns was implanted; however, now seizure control has decreased. The patient's seizure medication had to be increased due to the seizures.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=496020


Title: Re: Increase in seizures
Post by: dennis100 on November 29, 2011, 03:28:10 AM
Model Number 102
Event Type Malfunction
Manufacturer Narrative
Report is incomplete because no response has been received to manufacturer's requests for additional information from treating neurologist. Review of manufacturing records for both the pulse generator and the bipolar lead revealed no anomalies that would adversely effect deice performance.

Event Description
Reporter indicated that treating neurologist was unable to communicate with patient's device at office visit. The patient had reportedly experienced an increase in seizures and no longer experienced voice change with stimulation. It is not known whether the increase in seizures is above pre-vns baseline seizure frequency or merely an increase from efficacy previously obtained with the vns therapy. Based on reported device settings, the estimated battery life for the patient's generator was calculated to be 0. 56 to 1. 0 years. Investigation to date has been unable to determine whether the device has reached normal end of service due to the aggressive device settings or whether a malfunction occurred. Further follow-up revealed that the patient was scheduled for surgery.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=496592



Title: Re: Increase in seizures
Post by: dennis100 on November 29, 2011, 03:28:45 AM
Model Number 101
Event Date 10/11/2003
Event Type Injury Patient Outcome Life Threatening;
Event Description
Vns patient had a very bad seizure and almost died. It was reported that patient had been seizure-free for almost three years, but that in the past year the patient has had seizures shortly after leaving the physician's office. Programmed parameters have remained the same for two years and the only thing that physician has done to patient's device is interrogate it. The patient's family member is concerned that something may be wrong with the device. It was reported that the patient is exhibiting similar signs (facial drooping) as when they had a stroke.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=494772



Title: Re: Increase in seizures
Post by: dennis100 on November 29, 2011, 10:46:42 PM
Event Date 05/25/2004
Event Type Injury Patient Outcome Life Threatening; Hospitalization
Manufacturer Narrative
Report is incomplete because no response has been received to mfr's requests for additional info from treating neurologist.

Event Description
Reporter indicated that vns pt experienced a grand mal seizure for the first time. Reporter also indicated that the seizure lasted 2-3 minutes and that the pt vomited following the seizure. The pt was taken to the emergency room. Physician reportedly believes that the seizure was a result of the pt missing a dose of keppra. The pt's liver enzymes were reportedly elevated at that time, but have since normalized.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=537128


Title: Re: Increase in seizures
Post by: dennis100 on November 29, 2011, 10:47:20 PM
Model Number 101
Event Date 01/01/2004
Event Type Malfunction
Event Description
Reporter indicated that the pt is not having the response to vns therapy as in the past. The reporter also indicated that the pt's seizures are increasing. The reporter indicated that the magnet is no longer working for the pt. The pt's caretaker reported that they had swiped the device several times with the magnet to get it to stop a seizure. They were unsure if the magnet swipe stopped the seizure or the seizure ended. The pt indicated that they no longer felt magnet stimulation as in the past. Further follow-up with the pt's neurologist indicated that the pt was having 4 to 10 seizures a day even with medication increases and changing the vns settings. Physician indicated that the pt's seizures have not increased and it is unknown if the vns is related to the event.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=611967


Title: Re: Increase in seizures
Post by: dennis100 on November 29, 2011, 10:47:54 PM
Model Number 101
Event Date 06/01/2004
Event Type Injury Patient Outcome Life Threatening;
Manufacturer Narrative
Report is incomplete because no response has been received to manufacturer's requests for additional info from treating neurologist (via fax x2). The pt has been in jail for approximately 11 months.

Event Description
The reporter indicated that the pt is experiencing an increase in seizures and the device is not working. It is unk if the increase in seizures is above the pre-vns frequency. The reporter also stated that the pt is currently in jail and was 'beaten up' on their left side by the police.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=535386



Title: Re: Increase in seizures
Post by: dennis100 on November 29, 2011, 10:48:26 PM
Event Date 06/01/2004
Event Type Malfunction
Manufacturer Narrative
Investigation to date has been unable to rule out potential device malfunction. Report is incomplete because device tracking information was not forwarded to manufacturer after implant. Additionally, no response has been received to manufacturer's requests for additional information from treating neurologist (via fax x2).

Event Description
Vns pt could no longer feel device stimulation and that they were experiencing an increase in seizure activity from previous efficacy experienced with the vns therapy. The pt has recently been seen by treating neurologist, at which time they complained of no longer feeling device stimulation and an increase in seizure activity. Neurologist reduced programmed device off time from 5 minutes to 3 minutes at this office visit. The pt denies any recent injury or trauma that may have damaged the ncp system.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=535386



Title: Re: Increase in seizures
Post by: dennis100 on November 29, 2011, 10:48:55 PM
Model Number 102
Event Type Injury Patient Outcome Required Intervention;
Event Description
Reporter indicated that the pt is experiencing an increase in seizures above the pt's pre-vns baseline. It was also reported that the pt becomes irritated when the device stimulates. Neurologist indicated that the pt is not doing good and that the magnet is not effective in aborting the pt's seizures. It is unk if the magnet was ever effective in aborting the pt's seizures. Neurologist also indicated that the pt's overall health condition is not worsening and there has not been any environmental stimuli that could have caused the increase in seizures. Neurologist indicated that their has been a recent change in medications that could be contributing to the pt's increase in seizures. The pt requested the device be programmed to off due to feeling vibrations in their neck which were painful and uncomfortable.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=534777



Title: Re: Increase in seizures
Post by: dennis100 on November 29, 2011, 10:49:56 PM
Model Number 300-20
Event Type Malfunction
Manufacturer Narrative
H. 6. The vns therapy system is indicating for use as an adjunctive therapy in reducing the frequency of seizures in adults and adolescents over 12 years of age 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 over 12 years of age with partial onset seizures that are refractory to antiepileptic medications.

Event Description
Reporter indicated that device diagnostic testing at office visit resulted in high lead impedance reading (dc-dc code 7), indicating possible device malfunction. The elective replacement indicator was no, indicating that the generator was not at end of service. Additionally, it was reported that the pt was not experiencing their typical seizures. The pt reportedly experienced 6 grand mal seizures in a 1 1/2 month time period, which is considered to be an increase above pre-vns baseline frequency. The pt has pre-vns history of occassional grand mal seizures. The pt has not experienced any recent injury or trauma that may have damaged the ncp system and the pt does not manipulate the device through the skin. Neurologist ordered x-rays, increased pt's lamictal dosage and referred pt to neurosurgeon for consult. The pt has not experienced another episode of seizures since the increase in lamictal dosage and referred pt to neurosurgeon for consult. The pt has not experienced another episode of seizures since the increase in lamictal dosage. Review of manufacturing records for both the pulse generator and the bipolar lead revealed no anomalies that would adversely affect device performance

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=611910



Title: Re: Increase in seizures
Post by: dennis100 on November 29, 2011, 10:50:40 PM
Model Number 101
Event Date 01/01/2004
Event Type Injury Patient Outcome Life Threatening;
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 is experiencing an increase in seizures. It was reported that the pt has begun seizing every 60-90 seconds for 12-15 seconds each time. It was reported that the pt's device was programmed to rapid cycling (possibly 14sec on and 1. 1min off). Treating neurologist indicated that the pt's condition was fair and that the event was possibly related either to the vns or to the pt's worsening health condition. No intervention is planned or has been taken. Investigation to date has been unable to rule out the vns as the cause of the increase in seizure activity or to determine whether the seizure increase is above the pt's pre-vns baseline seizure frequency.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=534336



Title: Re: Increase in seizures
Post by: dennis100 on November 29, 2011, 10:51:49 PM
Model Number 101
Event Date 01/01/2004
Event Type Injury Patient Outcome Life Threatening;
Event Description
Reporter indicated that vns pt has recently experienced an increase in seizure activity. Investigation to date has been unable to determine whether it is simply an increase above previous efficacy experienced with the vns therapy or an increase above the pre-vns baseline frequency. Device diagnostic testing was within normal limits, indicating proper device function. The elective replacement indicator was no, indicating the generator had not reached end of service. Review of manufacturing records for both the pulse generator and the bipolar lead revealed no anomalies that would adversly effect device performance. Pre-vns seizure frequency is documented as being 1-2 noncatamenial seizures with generalized convulsions per month lasting 1-2 minutes. It was reported that these seizures occurred about 90% of the time during sleep and rarely clustered.

Manufacturer Narrative
Report is incomplete because no response has been received to mfr's requests for additional info from treating neurologist (questionnaire sent via fax twice).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=534610



Title: Re: Increase in seizures
Post by: dennis100 on November 29, 2011, 10:52:43 PM
Model Number 101
Event Date 04/26/2004
Event Type Injury Patient Outcome Life Threatening;
Manufacturer Narrative
H. 6. The vns therapy system is indicated for use as adjunctive therapy in reducing the frequency of seizures in adults and adolescents with parital 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 parital onset seizures that are refractory to antiepileptic medications. Vns therapy system labeling cautions not to program the vns therapy system to a on or periodic stimulation treatment for at least 14 days after the initial or replacment implantation. Failure to observe this precaution may result in pt discomfort or adverse events. Additionally, labeling states that during the first few weeks after implantation, the pt should be seen to confirm wound healing and proper pulse generator operation. The pulse generator's output current for both the magnet and the programmed stimulation must be 0. 0ma for the first 14 days after implantation.

Event Description
Reporter indicated that vns pt has experienced an increase in seizure frequency since vns implant. It was reported that the pt experienced one seizure every six weeks before vns implant and that since implant, the pt has a seizure shortly after each parameter adjustment. The pt's device was reportly programmed to on at the time of implant. Programmed parameters were reportedly increased approx two weeks later and the pt had a seizure the next day, which was less than six weeks since the pt's last seizure. It was reported that use of the magnet did not abort this seizure. Programmed device settings were again increased two weeks later and the pt had a seizure 13 days later. Use of the magnet was successful in aborting this seizure. Programmed parameters were again increased 8 days after the pt's last seizure and the pt reportedly experienced a seizure on the way home from the office visit. Use of the magnet was unsuccessful in aborting this seizure and diastat was administered. The pt's family member reports that drug levels were checked approx 3 weeks prior to last parameter increase and were within normal limits. The pt's seizure types have not changed and the pt's overall health condition is not worsening. There have been no medication changes and no known environmental stimuli that may have contributed to the increase in seizure activity. Treating neurologist indicated that the events were possibly related to adjustment of device parameters. No intervention is planned, however, neurologist is considering valium if pt continues to experience seizures after parameter adjustments.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=534424



Title: Re: Increase in seizures
Post by: dennis100 on November 29, 2011, 10:53:51 PM
Event Type Malfunction
Manufacturer Narrative
Report is incomplete because no response has been received to manufactur's request for additional information from treating neurologist. H. 6. Device manufacturing records were reviewed. H. 6. Vns therapy system labeling states that the pulse generator is usually implanted just below the clvicle in a subcutaneous pocket in the left upper chest. Suggested placement for the lead is the area of the left vagus nerve just above the clvicle, with the lead subcutaneously tuneled between the stimulation site in the nect and pocket formed in the upper chest. It is recommended that both the lead body and the pulse generator be positioned on the left side of the body. The cyberonics vns therapy tunneler is recommended for subcutaneous routing of the lead. Review of manufacturing records for the pulse generator revealed no anomalies that would adversely effect device performance.

Event Description
Device diagnostic testing at office visit resulted in high lead impedance reading (dc-dc code 7 and limit), indicating possible device malfunction. The elective replacement indicator was no, indicating that the pulse generator had not reached end of service. The patient reports that their seizure frequency had increased over the past 3 weeks and that they no longer feels stimulation. It was reported that the patient is usually very sensitive to device stimulation, but that they still could not feel it after treating neurologist indicated that the generator was originally implanted in the axillary area and that each time the patient turns their head, pulling of the lead wire can be visualized under the skin and something that resembles a tie-down "pokes out" treating neurologist ordered x-rays and has referred patient to neurosurgeon for follow-up.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=610828



Title: Re: Increase in seizures
Post by: dennis100 on November 29, 2011, 10:54:50 PM
Model Number 102
Event Date 08/01/2004
Event Type Injury Patient Outcome Life Threatening;
Manufacturer Narrative
Report is incomplete because the pt's neurologist did not respond to all of the mfr's questions. This event is currently under investigation.

Event Description
Since the pt had the vns implant they have been experiencing "a considerable" increase in seizures. Intraoperative device diagnostic testing was within normal limits, indicating proper device function at the time of implant. The pt was reportedly set to the lowest output setting two weeks following surgery and does not feel stimulation. Further follow-up revealed that the device output setting was increased to 0. 5ma and the pt could then feel stimulation. The treating neurologist indicated that the cause of the increase in seizures is unk.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=545267


Title: Re: Increase in seizures
Post by: dennis100 on November 29, 2011, 10:55:36 PM
Model Number 101
Event Date 08/01/2004
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. Analysis of the returned generator revealed no anomalies that would adversely affect device performance. The device was successfully interrogated and the elective replacement indicator was no, indicating that the generator had not reached end of service. The device met electrical test specifications and visual inspection criteria. Investigation to date had been unable to determine the cause of the apparent loss of seizure control. The patient has reportedly had no further seizures since generator replacement surgery this event is currently under investigation.

Event Description
Reporter indicated that vns patient underwent generator replacement surgery after only 11 months of service. It was reported that the patient was experiencing exacerbation of their condition similar to what is consistent with prior battery depletion. It was reported that the patient experienced "horrible seizures" for an entire week prior to generator replacement surgery and that they had also started having drop seizures, which was an extremely unusual seizure type for patient. It was reported that the last time the patient had seizures of this nature was when their previous generator had reached end of service. Device diagnostic testing at office visit prior to generator replacement surgery was within normal limits, indicating proper device function.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=612014



Title: Re: Increase in seizures
Post by: dennis100 on November 29, 2011, 10:56:19 PM
Model Number 300-20
Event Date 06/01/2004
Event Type Malfunction
Event Description
The reporter indicated that a lead test was done and resulted in a dcdc code of 7, limit, high and eri (elective replacement indicator) no, indicating a possible device malfunction. The reporter also stated that x-rays were done and were difficult to read. The reporter stated that the patient's seizure have begun to increase and the increase is above baseline (harder and more frequent). There have been no medication changes that may have attributed to the increase in seizure activity. Further follow-up with a nurse from the neurologist's office revealed the following; 1) evoked potential monitoring was done which in the their opinion confirmed a lead malfunction. 2) the patient frequently falls and this is suspected to be the cause of the alleged lead break. 3) medication changes were made in june to help control the patient's seizures. 4) the patient has 30-50 brief myoclonic seizures per month, and the seizures are more severe with falls and severe injuries including head lacerations have occurred. 5) patient has brief tonic/clonic seizures with drooling and the patient sometimes has non-epileptic seizures. 6) the patient recently had a clavicle fracture as a result of a seizure. Revision surgery was done, however, at this time it is unknown if the genertor and lead were replaced.

Manufacturer Narrative
At this time, the event is still under investigation.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=612087



Title: Re: Increase in seizures
Post by: dennis100 on November 29, 2011, 10:57:16 PM
Model Number 101
Event Date 08/01/2004
Event Type Injury Patient Outcome Required Intervention;
Manufacturer Narrative
H. 6. Unable to verify if the device was nearing end of service because the entire parameter history is unk at this time.

Event Description
The pt is experiencing an increase in seizures above their pre-vns baseline frequency. The reporter also indicated that the "last couple" of magnet activations were not displayed. The reporter believed that the generator was nearing end of service. Further follow-up concluded that the pulse generator was replaced and the physician indicated that this is "not an incident. " the pt seizure efficacy has returned and the pt is doing well. No serious injuries were reported due to the seizure increase. A battery life estimation was performed using the last known device settings. The estimation concluded that the device was nearing its end of life with approx 6 months left. Review of manufacturing records for the pulse generator revealed no anomalies that would adversely effect device performance.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=543663



Title: Re: Increase in seizures
Post by: dennis100 on November 29, 2011, 10:57:56 PM
Event Date 01/01/2004
Event Type Injury
Patient Outcome Life Threatening;
Manufacturer Narrative
Report is incomplete because attempts (1 letter to hospital, 1 fax to surgeon, 1 fax to neurologist) to obtain additional information from physician have been unsuccessful to date. The hospital did not forward implant data to the manufacturer.

Event Description
Prior to the vns implant, pt was experiecing one seizure a month and now pt is having one a week. The reporter also stated that there have been no medication changes and the magnet is effective in stopping the seizures. The cause of the increase in seizures is unknown at this time.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=543694



Title: Re: Increase in seizures
Post by: dennis100 on November 29, 2011, 10:58:47 PM
Model Number 102
Event Date 08/14/2004 Event Type Injury Patient Outcome Hospitalization; Event Description
The reporter indicated that the pt is experiencing an increase in seizures. The pt experienced status and went to the emergency room. The reporter indicated that they are not sure if the pt is adequately receiving their medications from the care takers at the group home where they reside. Further follow-up revealed that diagnostic test was performed and resulted in a dcdc code of 3 indicating proper device function. The neurologist also reported that the pt is still having seizures (5 within one month). An increase in the device settings and an increase in trileptol is planned. The pt's neurologist reported that it is unknown if the increase in seizures is related to the vns therapy.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=543383



Title: Re: Increase in seizures
Post by: dennis100 on November 29, 2011, 10:59:36 PM
Model Number 102
Event Date 06/01/2004
Event Type Injury Patient Outcome Hospitalization;
Manufacturer Narrative
H6. The vns therapy system is indicated for use as an adjunctive therapy in reducing the frequency of seizures in adults and adolescents over 12 years of age 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 over 12 years of age with partial onset seizures that are refractory to antiepileptic medications.

Event Description
The reporter indicated that after the pt received their vns implant, they started having several seizures, which were more violent than before. Approximately 2. 5 weeks following the vns implant, the pt was hospitalized (icu) due to severe seizures. The reporter also stated that the pt had severe sleep apnea which they had never had before. The generator was reprogrammed at the hospital. The reporter stated that the pt is now doing "great. " further follow-up with the treating neurologist revealed that device parameters were increased approximately two months following the reported event, and the pt is stable. The physician also reported that the event is "probably not" related to the vns; it may have occurred because of medications

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=543385



Title: Re: Increase in seizures
Post by: dennis100 on November 29, 2011, 11:00:25 PM
Event Date 02/10/2004
Event Type Injury Patient Outcome Life Threatening;
Manufacturer Narrative
Report is incomplete because product information was not forwarded to manufacturer after implant. No response has been received to manufacturer's requested for product information from implanting hospital.

Event Description
Reporter indicated that pt's seizures have worsened in frequency and severity since vns implant. It was reported that use of the magnet had no effect on the pt's seizures and that the pt's recovery time has increased. The pt continues to have seizures that last 3-6 minutes and continues to be immobile for 1-2 hours after a seizure with a 4-6 hour recovery time. The pt was seen for follow-up by neurologist 6 days after the event was reported to the manufacturer, at which time both the neurologist and the pt's family member determined that their seizures were improving. It was reported that over the past two months, there had been a decrease in the pt's seizure clusters and the pt experienced only 1-2 grand mal seizures per week instead of 4 days in a row of seizures followed by 4 days with no grand mal seizures.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=543167



Title: Re: Increase in seizures
Post by: dennis100 on November 29, 2011, 11:01:16 PM
Model Number 102R
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. This event is currently under investigation.

Event Description
Reporter indicated that vns patient had undergone generator replacement surgery due to end of service approximately 11 months ago, but has begun having seizures again. It was reported that the patient normally gets great results with the vns therapy and that treating neurologist was surprised that the patient was having seizures again. It was reported that the patient was experiencing an increase in seizure activity above previous efficacy with the vns therapy and not an increase above pre-vns baseline frequency. Investigation to date has been unable to rule out possible device malfunction due to conflicting reports of device diagnostic test results. It was initially reported that normal mode test resulted in high lead impedance reading (dc-dc code 7), indicating that the generator battery may have depleted to the point that the device is no longer able to deliver 2. 25ma normal mode output current as prescribed. It was later reported that lead test resulted in dc-dc code 7 and ok, which is not an expected test result. Lead test results with an impedance of dc-dc code 7 would be expected to yield output current status of limit as opposed to ok as reported. Neurologist indicated that the patient is currently doing well and that there are no plans for intervention at this time. Neurologist plans to follow-up with patient in one month, at which time device diagnostic testing will be performed again.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=612111



Title: Re: Increase in seizures
Post by: dennis100 on November 29, 2011, 11:02:19 PM
Model Number 102
Event Date 08/01/2004
Event Type Injury Patient Outcome Life Threatening;
Event Description
Reporter indicated that vns patient experienced 11 seizures in one day and that the patient could not feel either normal mode device stimulation. Additionally, it was reported that magnet swipes by the patient were not registering in the device programming history. Device diagnostic testing was within normal limits, indicating proper device function. The elective replacement indicator was no, indicating that the generator had not reached end of service. Device interrogation following a magnet swipe performed in neurologist's office while applying slight pressure to the device did register in the device programming history. At that point, the neurologist indicated that she believed that the patient's problem was simply that the patient was not receiving efficacy from the vns therapy. Investigation to date has been unable to determine if the episode of 11 seizures in one day was above pre-vns baseline seizure frequency for the patient.

Manufacturer Narrative
Report is incomplete because no response has been received to manufacturer's requests for additional information from treating neurologist(via fax x2).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=543306



Title: Re: Increase in seizures
Post by: dennis100 on November 29, 2011, 11:03:07 PM
Event Date 07/08/2004
Event Type Injury Patient Outcome Life Threatening;
Manufacturer Narrative
Report is incomplete because attempts to obtain additional information have been unsuccessful to date.

Event Description
Reporter indicated that vns patient has experienced an increase in seizures since implant. Treating neurologist increased programmed device output current, but reportedly does not believe that the seizure increase was related to the vns. The patient is scheduled for follow-up with the neurologist in one month.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=543310



Title: Re: Increase in seizures
Post by: dennis100 on November 29, 2011, 11:04:14 PM
Model Number 102
Event Date 08/01/2004
Event Type Injury Patient Outcome Life Threatening;
Manufacturer Narrative
H. 6. Neurologist indicated that the event was not related to the vns therapy system and that it was normal fluctuation in seizure frequency.

Event Description
Reporter indicated that pt has experienced an increase in seizure activity above pre-vns baseline frequency since a recent adjustment to programmed parameters. Additionally, it was reported that the pt had not yet experienced efficacy with the vns therapy and that use of the magnet only provides seizure control if the seizure is caught early. Follow-up with treating neurologist revealed that the pt's seizure frequency had returned to baseline. Device diagnostic testing was within normal limits, indicating proper device function. No intervention is planned.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=542668


Title: Re: Increase in seizures
Post by: dennis100 on November 29, 2011, 11:05:10 PM
Model Number 102
Event Date 08/02/2004
Event Type Injury Patient Outcome Life Threatening;
Event Description
Further follow-up revealed that the device was programming to off. The patient reported that she wants the vns theraphy system explanted.

Manufacturer Narrative
Report incomplete because no response has been received to mfr's requests for additional info from treating neurologist.

Event Description
Reporter indicated that vns pt has experienced an increase in seizure activity since the last increase to device programmed output current. The pt typically experiences 1-2 seizures per week, but that after the increase in output current pt experienced 5 seizures in 4 days. The pt plans to follow-up with their neurologist.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=542178



Title: Re: Increase in seizures
Post by: dennis100 on November 29, 2011, 11:05:55 PM
Model Number 102
Event Date 08/02/2004
Event Type Injury Patient Outcome Life Threatening;
Event Description
Further follow-up revealed that the device was programming to off. The patient reported that she wants the vns theraphy system explanted.

Manufacturer Narrative
Report incomplete because no response has been received to mfr's requests for additional info from treating neurologist.

Event Description
Reporter indicated that vns pt has experienced an increase in seizure activity since the last increase to device programmed output current. The pt typically experiences 1-2 seizures per week, but that after the increase in output current pt experienced 5 seizures in 4 days. The pt plans to follow-up with their neurologist.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=542178



Title: Re: Increase in seizures
Post by: dennis100 on November 29, 2011, 11:07:06 PM
Model Number 302-20
Event Date 02/02/2004
Event Type Injury Patient Outcome Life Threatening; Disability
Manufacturer Narrative
H. 6. Vns therapy system labeling lists voice alteration (hoarseness) as a potential adverse event possibly associated with surgery or stimulation.

Event Description
Vns pt has experienced an increase in seizure activity above pre-vns baseline frequency and no improvement in hoarseness since implant. It was reported that the pt's voice is "very soft and hoarse. " the pt reportedly sleeps with their magnet attached to their wrist. Treating neurologist indicated that the pt's pre-vns seizure varied from 1 seizure per month to 2-3 seizures per week and that since implant, the pt's seizure frequency had not reduced. The pt's seizure types have not changed and their overall health condition is not worsening. There are no recent medication changes or environmental stimuli that may have contributed to the reported increase in seizure activity.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=541541



Title: Re: Increase in seizures
Post by: dennis100 on November 29, 2011, 11:07:54 PM
Event Date 07/18/2004
Event Type Injury Patient Outcome Life Threatening;
Manufacturer Narrative
Report is incomplete because no response has been received to mfr's requests for additional info from treating neurologist.

Event Description
Reporter indicated that vns pt experienced an increase in seizure activity after initiation of stimulation. It was reported that the pt had been seizure-free for approximately six months. Device stimulation was initiated approximately 26 days post-implant and the pt experienced a seizure on that day after stimulation was initiated. Two days later, the pt had 3 seizures and device output current was increased from 0. 25ma to 0. 50ma. The following day the pt had 2 seizures. Two days later, the pt had 2 more seizures, then 2 more seizures the next day and 3 more seizures the day after that. Two days later the pt experienced 1 seizure per day for two days in a row and reportedly has not had any other seizures since that time.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=540907



Title: Re: Increase in seizures
Post by: dennis100 on November 29, 2011, 11:08:34 PM
Model Number 101
Event Date 07/01/2004
Event Type Injury Patient Outcome Life Threatening;
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 experienced an increase in drop attacks. The pt reportedly experienced 40/day for one week. It is not known whether this was an increase above pre-vns baseline frequency or an increase above previous efficacy with the vns therapy, although it was reported that the pt had previously been seizure-free for approximately two months. Device diagnostic testing was within normal limits, indicating proper device function. The elective replacement indicator was no, indicating that the generator had not reached end of service. The pt's condition was reported as stable and pt is scheduled for follow-up with their primary neurologist. It was reported that the pt had knots on their left neck that were felt to be the "tie downs". The pt's family member was instructed to observe for skin breakdown in these areas.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=540921



Title: Re: Increase in seizures
Post by: dennis100 on November 29, 2011, 11:38:02 PM
Event Date 06/14/2004
Event Type Injury Patient Outcome Life Threatening; Hospitalization Required Intervention
Event Description
Reporter indicated that vns pt was experiencing an increase in seizure activity above pre-vns baseline frequency. It was reported that the pt experienced 15 seizures one day and 11 seizures so far the next day at the time of the initial report. It was reported that caregivers were able to abort the seizures by initiating magnet mode stimulation. The pt's neurologist was on vacation and it was reported that caregivers were advised by neurologist's office to take the pt to the emergency room for eval if they felt that the seizure increase was a medical emergency. The pt was taken to hosp emergency room by caregivers and reportedly experienced 50 seizures while in hosp emergency room. Valium ivp was administered three times during the emergency room visit and a prescription for diastat was written for use upon discharge from hosp emergency room. Caregivers cannot tell if the pt feels stimulation as pt is nonverbal. The pt has reportedly suffered no recent injury or trauma that may have damaged the vns therapy system. Caregivers plan to follow-up with treating neurologist

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=534609


Title: Re: Increase in seizures
Post by: dennis100 on November 29, 2011, 11:40:13 PM
Model Number 102
Event Date 07/16/2004
Event Type Injury Patient Outcome Life Threatening; Hospitalization
Event Description
The rptr indicated that approx one hr following the vns implant surgery, the pt went into status, was reintubated, and admitted to the icu. The pt was reportedly given iv antiepileptic medications and was hospitalized for two days for observation. Further follow-up with the neurologist concluded that the pt is now doing "excellent" and the event of status was not related to the vns implant. Stimulation had not been initiated at the time of the event. The neurologist also reported that the event was most likely caused by emotional stress and believed to be nonepileptic.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=539782


Title: Re: Increase in seizures
Post by: dennis100 on November 29, 2011, 11:40:43 PM
Model Number 100
Event Date 01/01/2000
Event Type Injury Patient Outcome Life Threatening; Required Intervention
Manufacturer Narrative
Report is incomplete because treating neurologist did not fully respond to mfr's request for add'l info, stating that there was no incident and that it was not a cyberonics problem. ".

Event Description
In the process of contacting the pt's neurologist to notify him that the pt's device may be nearing end of service, it was discovered that the pt's device was programmed to off over four years ago due to an increase in seizures. It was reported that normal mode output current was programmed to off, but that magnet mode output current remained programmed to on. At the time that the normal mode output current was programmed to off, the pt's family member reported to treating neurologist that the pt was experiencing an increase in seizures. Six months after the device was programmed to off, the pt's family member reported to neurologist that the pt's seizures had declined to nocturnal events only and lasted only 10-15 seconds at a time. The normal mode output current was never programmed back to on. Treating neurologist indicated that he got conflicting info from the pt's family member and that every time they do more to treat the pt, the pt does poorly. Device diagnostic testing within normal limits, indicating proper device function.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=539385



Title: Re: Increase in seizures
Post by: dennis100 on November 29, 2011, 11:41:10 PM
Event Date 05/25/2004
Event Type Injury Patient Outcome Life Threatening;
Event Description
Vns pt has experienced an increase in seizures since implant. It was reported that the pt only had seizures around the time of their menses before vns implant, but that since implant they have had numerous seizures and 2 grand mal seizures. One of the grand mal seizures seemed to be brought on by swiping the device with the magnet. Pt plans to follow-up with treating neurologist for device diagnostic testing.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=539409


Title: Re: Increase in seizures
Post by: dennis100 on November 29, 2011, 11:41:50 PM
Model Number 101
Event Date 06/15/2004
Event Type Injury Patient Outcome Hospitalization;
Event Description
The reporter indicated that the pt was experiencing numerous breakthrough seizures, including drop attacks. The pt was seen in the emergency room and had suffered multiple lacerations requiring suturing. It was further reported that the pt fractured their front teeth due to the seizures. The reporter also stated that the ncp pulse generator was checked and was found to be non-functioning, likely due to normal end of service. The pt was scheduled for a generator replacement. Further follow-up revealed that while replacing the generator, the surgeon inadvertently cut the lead, therefore, the entire system was replaced. The generator was returned and analyzed. Bench testing in the product analysis lab confirmed that the unit would interrogate and program properly. Diagnostic testing was performed which resulted in "ok" for lead impedance, a dc-dc code of 2, and a "yes" for eri (elective replacement indicator). The device was found to be operating within specification. No anomalies were detected or identified that could have an adverse effect on performance. The device had low battery voltage.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=538906



Title: Re: Increase in seizures
Post by: dennis100 on November 29, 2011, 11:42:39 PM
Model Number 102R
Event Date 06/14/2004
Event Type Injury Patient Outcome Life Threatening; Hospitalization
Manufacturer Narrative
Report is incomplete because no response has been received to mfr's requests for additioinal info from treating neurologist (via fax x2).

Event Description
Reporter indicated that vns pt was hospitalized for 6 days due to an increase in seizures. Reporter also indicated that the pt has experienced the increase in seizures since generator replacement surgery due to end of service approx 1 month prior

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=538968


Title: Re: Increase in seizures
Post by: dennis100 on November 29, 2011, 11:44:39 PM
Model Number 300-20
Event Type Malfunction Patient Outcome Life Threatening; Hospitalization Required Intervention
Event Description
Reporter indicated that device diagnostic testing at office visit resulted in high lead impedance reading (dc-dc code 7 and limit), indicating possible device malfunction. The elective replacement indicator was no, indicating that the generator had not reached end of service. It was reported that the pt had recently undergone generator replacement surgery and that intraoperative device diagnostic testing of the new generator connected to the original lead was within normal limits, indicating proper device function at that time. The pt was reportedly doing well approximately two months after generator replacement surgery. Approximately six months after generation replacement surgery, it was reported that the pt continued to do well with the vns therapy and that use of the magnet did abort their smaller seizures, but that they had other medical issues and had gone into status a few times. Further follow-up four months later revealed that the pt was seizing terribly and that it was suspected that the pt's lead was broken. Review of x-rays revealed a probable break in the lead coil wire, as no strain relief loop was present. The pt is nonverbal and cannot communicate whether or not they feel device stimulation. It was reported that the pt wears a helmet because their seizures are so violent, but it is unk whether the pt had suffered any recent injury or trauma that may have damaged the ncp system. The pt underwent vns therapy system replacement. Both the pulse generator and bipolar lead were replaced.

Manufacturer Narrative
Review of manufacturing records for the bipolar lead revealed no anomalies that would adversely affect device performance.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=611885



Title: Re: Increase in seizures
Post by: dennis100 on November 29, 2011, 11:45:35 PM
Model Number 101
Event Date 01/01/2004
Event Type Injury Patient Outcome Life Threatening;
Manufacturer Narrative
Report is incomplete because no response has been received to mfr's requests for additional info from treating neurologist 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.

Event Description
Reporter indicated that vns pt was experiencing an increase in seizure activity above pre-vns baseline frequency. It was reported that the pt's seizures were almost constant. Treating neurologist suspected generator end of service, but had not performed device diagnostic testing to confirm. Review of manufacturing records for both the pulse generator and the bipolar lead revealed no anomalies that would adversely effect device performance.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=538843




Title: Re: Increase in seizures
Post by: dennis100 on November 29, 2011, 11:46:13 PM
Model Number 102
Event Date 01/09/2004
Event Type Injury Patient Outcome Life Threatening; Hospitalization
Manufacturer Narrative
Report is incomplete because no response has been received to mfr's request for additional info from treating neurologist (via fax x1).

Event Description
Rptr indicated that vns pt was hospitalized approx two mos post-implant due to an episode of status epilepticus. The pt's seizures are stronger and more intense since vns implant, although use of the magnet does help to abort seizures. Treating neurologist reportedly indicated that the pt needed to "push through" the time period following implant to get to a level of vns therapy that works best for pt and that it can take time before they see good results. No medication changes have been made.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=538306



Title: Re: Increase in seizures
Post by: dennis100 on November 29, 2011, 11:46:59 PM
Model Number 300-20
Event Date 01/01/2004
Event Type Injury Patient Outcome Life Threatening; Required Intervention
Manufacturer Narrative
The pt's device was programmed to off in or before feb. 2002 as the pt did not feel that the vns therapy helped them. It was later reported that the device was programmed back to on and that the vns therapy did help with the pt's seizures and stopped their breakthrough seizures. With the device programmed to off, the pt's seizures reportedly increased in frequency and severity to a life-threatening level. It is not known how long the device was programmed to off.

Event Description
In the process of contacting the pt to notify their that their device may be nearing end of service, it was discovered that the pt had suffered injury due to an increase in seizures. The pt's seizures are reportedly becoming very severe, resulting in the pt's splitting their lip and tongue and breaking some of their teeth down to the gum line. The pt was evaluated by an ent for lip and tongue repair, but the ent reportedly does not want to perform surgery at this time as he does not feel that the pt is surgically stable due to the increased seizure activity. Additionally, the pt reports that after the seizure increase began, they felt a pulling sensation when they turned their head to the left and experienced eye pain for the remainder of the day. The pt also reports neck pain at the site of the lead wire. Device diagnostic testing reportedly revealed that the generator was not at end of service. Treating neurologist decreased device settings due to pt complaints.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=538375



Title: Re: Increase in seizures
Post by: dennis100 on November 29, 2011, 11:47:31 PM
Event Date 05/01/2004
Event Type Injury Patient Outcome Life Threatening; Required Intervention
Event Description
Reporter indicated that vns pt experienced an increase in seizure activity above pre-vns baseline frequency. It was reported that the pt experienced between 0-4 seizures per month before vns implant and that they recently experienced 13 seizures in one month. Treating neurologist indicated that the seizure increase was not related to the vns therapy and was possibly caused by a variation in the pt's phenobarbital levels. Neurologist reported that the pt's phenobarbital level dropped and that the dosage was subsequently increased. The pt's overall health condition is not worsening and there were no environmental stimuli that may have contributed to the increase in seizure activity. The elective replacement indicator was no, indicating that the generator had not reached end of service. The pt's seizure frequency has reportedly more or less returned to baseline.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=538377



Title: Re: Increase in seizures
Post by: dennis100 on November 29, 2011, 11:48:21 PM
Model Number 102
Event Date 07/05/2004
Event Type Injury Patient Outcome Life Threatening; Hospitalization Required Intervention
Event Description
Reporter indicated that vns pt was seen in hosp e. R. With multiple seizures over the preceding five days. The pt was reportedly hospitalized for 2 days. It was reported that the pt experienced an increase in seizure activity over pre-vns baseline frequency after stimulation was initiated. Additioanally, the pt indicated that they were not shown how to use the magnet and does not feel magnet mode stimulation. The pt also reports shortness of breath with stimulation. The pt presented to hosp e. R. A second time approximately 5 days after being discharged. At this second visit, the pt indicated that they were experiencing more seizures, but treating physician (not the same physician who treated the pt at the time of their first visit) indicated that the pt was having tremors and not seizures. Further follow-up with treating neurologist indicates that the pt is doing fine and that their symptoms were possibly related to anxiety. Neurologist indicated that the pt is extremely anxious. Neurologist indicated that the pt is likely attributing their problems to the vns which is not likely the issue. Neurologist lowered normal mode output current from 0. 50ma to 0. 25ma.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=538034



Title: Re: Increase in seizures
Post by: dennis100 on November 29, 2011, 11:49:01 PM
Model Number 102
Event Date 05/07/2004
Event Type Injury Patient Outcome Life Threatening;
Manufacturer Narrative
Report is incomplete because no response has been rec'd to mfr's requests for add'l info from treating neurologist.

Event Description
Reporter indicated that vns pt has experienced an increase in seizures above pre-vns baseline frequency since implant. It was also reported that there had been some medication changes during this time and that it was not known whether the seizure increase was due to the vns therapy or the medication changes. Pt plans to follow-up with their neurologist about temporarily discontining vns stimulation to see if the seizure increase persists in the absence of the vns therapy.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=537866



Title: Re: Increase in seizures
Post by: dennis100 on November 29, 2011, 11:49:44 PM
Model Number 101
Event Type Malfunction
Event Description
Reporter indicated that pt underwent explanted of the ncp system due to suspected device malfunction. It was reported that the pt did not benefit from the vns therapy and that their seizures were actually worse after implant. Additionally, the pt experienced intermittent stimulation with certain neck movement and a sleep study reportedly showed that the pt became bradycardiac more than 200 times per night. The pt's device was susequently programmed to off and the pt reportedly experienced no seizures over an 18 month period of time since discontinuing stimulation and undergoing changes to their medication regimen. The pt later requested explant of the ncp therapy system.

Manufacturer Narrative
Review of mfg records for both the pulse generator and the bipolar lead revealed no anomalies that would adversely affect device performance. Analysis of the returned pulse generator revealed no anomalies. The device operated within specification. External visual inspection revealed no anomalies and the device met electrical test specifications. Only the lead connectors were returned for analysis. A continuity check using a multimeter revealed no discontinuities in the portion of the lead that was returned. The condition of the lead was consistent with conditions that exist after the explant procedure.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=612023



Title: Re: Increase in seizures
Post by: dennis100 on November 29, 2011, 11:50:32 PM
Model Number 100
Event Type Injury Patient Outcome Required Intervention;
Event Description
Reporter indicated that vns pt experienced an increse in seizures activity along with headache and anorexia when programmed output current was titrated to 3. 5ma. Output current was subsequently reduced to 0. 50ma, after which the pt's appetite and alertness improved but there was no reduction in seizure frequency below pre-vns baseline. It was reported that after vns implanted, the pt's seizures continued for one year without change. There was then a 50% decrease in the frequency of astatic episodes. After three years, the seizures abrupty disappeared without any further change in drug therapy or stimulation intensity. Investigation to date has been unable to determine the cause of the reported increased in seizure frequency.

Manufacturer Narrative
Report is incomplete because attempts to obtain additional info from the author of the article have been unsuccessful to date. Author cited strict privacy laws in their country of practice as the reason for not providing pt and/or product info to device mfr.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=562707



Title: Re: Increase in seizures
Post by: dennis100 on November 29, 2011, 11:51:23 PM
Model Number 101
Event Date 11/01/2004
Event Type Injury Patient Outcome Required Intervention;
Event Description
Product analysis summary: initial interrogation of the pulse generator found that the output current was at 0ma. The pulse generator is operating within the designed limits, meeting the manufacturers final electrical test specifications. There were no anomalies noted that would have contributed to reported increased seizures and high impedance events. Product analysis was also performed on the concomitant device (lead): product analysis summary: a lead break occurred due to fatigue and torsion of the lead. It is believed that the packing wire contributed to the break by reducing the flexibility of the coil. It is believed that the lead broke while stimulation was present, however, a conclusive determination could not be made. A continuity check on the positive side of the lead portion returned did not identify any discontinuities. Other conditions of the lead are consistent with conditions that exists after the explant procedure.

Event Description
Reporter indicated that vns pt has experienced a recent increase in seizure activity. Treating neurologist indicated that it was not known whether the increase in seizure activity was above pre-vns baseline frequency. Device diagnostic testing revealed that the pt's device was no longer able to deliver the prescribed output current, but was not indicative of malfunction. The elective replacement indicator was no, indicating that the generator had not reached end of service; however, it is believed that the pt's generator may be approaching end of service and is therefore still able to delivery stimulation, but not at the prescribed settings. Pending revision surgery, device settings were adjusted until normal mode testing yielded ok impedance readings, indicating that the pt was receiving the vns therapy as programmed. Normal mode output current was reduced from 2. 5ma to 1. 0ma with pulse width increased from 500usec to 750usec. 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 the cause of the reported increase in seizure activity.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=562710



Title: Re: Increase in seizures
Post by: dennis100 on November 29, 2011, 11:52:09 PM
Model Number 101
Event Date 11/01/2004
Event Type Injury Patient Outcome Life Threatening;
Event Description
Product analysis summary: the pulse generator met electrical test specification. There were no visual anomalies identified or observed. No performance anamalies were noted. The pulse generator did not show any condition that would have contributed to the report increase in seizures or suspected end of service. The device was not at end of service. The cause of the increase in seizures in uknown. Possibly causes for the patient's increase in seizures are external stimuli (i. E. Stress), family issues, other illness not related to epilepsy and non-compliance with medications. However, without information from treating neurologist the exact cause of the reported event cannot be determined.

Event Description
Vns pt has recently experienced an increase in seizure activity. It was reported that the pt uses the magnet a lot to initiate magnet mode stimulation and that their device is programmed to the highest possible normal mode output current (3. 5ma). Treating neurologist plans to perform device diagnostic testing in an attempt to determine whether the pt's generator is nearing normal end of service. Investigation to date has been unable to determine whether the reported increase in seizure activity is an increase above pre-vns baseline frequency or simply an increase above previous efficacy with the vns therapy.

Manufacturer Narrative
Report is incomplete because no response has been received to mfr's requests for additional info from treating neurologist (via telephone x1, via fax x2).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=562324



Title: Re: Increase in seizures
Post by: dennis100 on November 29, 2011, 11:52:51 PM
Model Number 102
Event Date 11/01/2004
Event Type Injury Patient Outcome Life Threatening; Required Intervention
Manufacturer Narrative
Report is incomplete because no response has been received to manufacturer's requests for additional information from treating neurologist (face-to-face x1, via fax x1).

Event Description
Vns pt experienced an increase in seizure frequency, possible above pre-vns baseline frequency. It was reported that the pt recently experienced 3-4 seizures in one month. Manufacturer has not been able to obtain pre-vns seizure data from treating neurologist to date and has conflicting data on file the pt. Per manufacturer's records, the pt's pre-vns seizure frequency is documented as being both 0-4 seizures per month and 1 seizure every 6 months. In comparison to the latter, the current seizure rate reported is above pre-vns baseline frequency. Treating neurologist reportedly increased the pt's zonegran dosage and the pt plans to follow-up with their gynecologist regarding the possibility of hormonal changes causing the increase in seizure activity as the seizure occur at the end of what would have been their monthly cycle. It was reported that treating neurologist discontinued the pt's dilantin and tegretol at the same time prior ot vns implant, leaving the pt on only zonegran. Investigation to date has been unable to determine the cause of the reported increase in seizure activity.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=562388



Title: Re: Increase in seizures
Post by: dennis100 on November 29, 2011, 11:53:36 PM
Model Number 101
Event Date 01/01/2003
Event Type Injury Patient Outcome Life Threatening; Required Intervention
Manufacturer Narrative
H. 6. Ncp system labeling states that the safety and efficacy of this therapy have not been systematically established for use in pts with history of previous therapeutic brain surgery. Treating neurologist indicated that the increase in seizure activity was not related to the vns therapy but was possibly caused by the "natural history of epilepsy".

Event Description
Reporter indicated that the pt experienced an increase in seizure activity above pre-vns baseline frequency. It was reported that the pt's device was programmed to off approximately two years post-implant because the pt never received efficacy from the vns therapy and their seizures worsened. The pt plans to have the ncp system explanted. Review of device programming history did not reveal any programming anomalies. There were reportedly no environmental stimuli or medication changes that could have contributed to the reported increase in seizure activity.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=561954


Title: Re: Increase in seizures
Post by: dennis100 on November 29, 2011, 11:54:19 PM
Event Date 09/01/2004
Event Type Injury Patient Outcome Life Threatening;
Manufacturer Narrative
Report is incomplete because device tracking information was not forwarded to manufacturer after implant and attempts to obtain it from implanting hospital via telephone have been unsuccessful to date.

Event Description
Reporter indicated that vns pt has experienced an increase in seizure activity above pre-vns baseline frequency. It was reported that the pt experienced 1-2 seizures per day before vns implant and that pt was now experiencing 3-4 seizures per day for the past two months. The pt has not suffered any recent injury or trauma that may have damaged the vns therapy system. The pt's spouse reported that swiping the device with the magnet was no longer successful in bringing the pt out of their seizures and the pt reports that the device "moves around" when pt lies on their left side. The pt plans to follow-up with a neurologist that is closer to their home because their current neurologist is over 100 miles away. Investigation to date has been unable to determine the cause of the reported increase in seizure activity

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=561963



Title: Re: Increase in seizures
Post by: dennis100 on November 29, 2011, 11:55:22 PM
Model Number 102R
Event Date 11/20/2004
Event Type Injury Patient Outcome Required Intervention;
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.

Event Description
Reporter indicated that vns pt experienced an increase in seizure activity after an increase in device normal model (to 0. 50ma) and magnet mode (to 0. 75ma) output currents. The pt's family member reported that the day after the increase in programmed parameters, use of the magnet seemed to "aggravate" the pt's seizures and the pt had more seizures than usual (increased from 1-2 seizures per day to 1-3 seizures per day in clusters). Additionally, the pt complained that their head was hurting and that pt felt some tingling. Treating neurologist reportedly told the pt's family member that their pt was having a reaction to the increase in programmed settings and that it would take a couple of days for their body to adjust. Neurologist instructed the family to give the pt an extra dose of phenobarbital and to give the additional pm dose of klonopin. There were no prior medication changes that may have contributed to the reported increase in seizure activity. The pt's family member indicated that the pt experienced some increased stress prior to the increase in device settings and neurologist indicated that the pt experienced an increase in seizure frequency with erupting molars. Neurologist indicated that it was initially unknown whether the pt's overall health condition was worsening because they had a prolonged upper respiratory infection and sinusitis. Use of the magnet was successful in aborting the pt's partial seizures. Further follow-up with neurologist revealed that the pt continues to experience breakthrough seizures, but that their overall condition had improved with regard to seizure frequency. The pt had no further complaints of headache or tingling at follow-up visit two weeks after the first increase in programmed settings. Both the normal mode and magnet mode output currents have been further increase (to 0. 75ma and 1. 0ma respectively) and the pt's keppra dosage has been reduced. Investigation to date has been unable to determine the cause of the reported increase in seizure frequency.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=561288



Title: Re: Increase in seizures
Post by: dennis100 on November 29, 2011, 11:56:06 PM
Model Number 101
Event Date 01/01/2004
Event Type Injury Patient Outcome Life Threatening;
Manufacturer Narrative
Report is incomplete because no response has been received to mfr's requests (via fax x 2) for additional info from treating neurologist.

Event Description
Reporter indicated that pt has experienced a recent increase in the number of partial seizures. There have reportedly been no medication changes that may have contributed to the increase in seizure activity. Investigation to date has been unable to determine the cause of the reported increase in seizure activity.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=560430


Title: Re: Increase in seizures
Post by: dennis100 on November 29, 2011, 11:57:31 PM
Model Number 102
Event Date 11/01/2004
Event Type Injury Patient Outcome Life Threatening;
Manufacturer Narrative
Report is incomplete because no response has been received to mfr's requests (via fax x2) for additional info from treating neurologist.

Event Description
Vns pt has experienced a recent increase in seizure activity with urinary incontinence and tongue biting. Investigation to date has been unable to determine the cause of the reported events.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=560434


Title: Re: Increase in seizures
Post by: dennis100 on November 29, 2011, 11:58:16 PM
Model Number 300-20
Event Type Malfunction
Event Description
It was further reported by the dr that the pt's current condition is stable; however, the pt's seizure frequency has not returned to the level prior to the reported malfunction. Three portions (371 mm) of the lead were for analysis. Analysis was performed on the lead portions that were returned. The lead portions passed continuity checks and the lead condition is consistent with conditions that typically exist following an explant procedure. The lead pins showed evidence that there was a proper mechanical and electrical connection between the lead pin and the pulse generator. The analyses performed on the returned lead portions gave no evidence of any condition that could have contributed to the reported high impedance. Without confirmation of a lead break, the cause of the high impedance is unk. Possible causes include design, durability, corrosion, trauma to the site or user error. The concomitant device (pulse generator) was also returned and analyzed. The pulse generator met final electrical test specifications. There is no indication that the reported high impedance was related to the pulse generator. The reported increase in seizures were likely caused by the loss of therapy due to the reported lead anomaly.

Manufacturer Narrative
H. 6: ncp system labeling states that the safety and efficacy of this therapy have not been systematically established for use in pts with history or previous therapeutic brain surgery.

Event Description
Reporter indicated that device diagnostic testing at two office visits (approximately six months apart) resulted in high lead impedance reading (dc-dc code 7 and limit), indicating possible device malfunction. The elective replacement indicator was no, indicating that the generator had not reached end of service. The pt's family member reports that pt's seizures had increased in frequency and intensity. But that the increase is not above pre-vns baseline.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=612040



Title: Re: Increase in seizures
Post by: dennis100 on November 29, 2011, 11:59:01 PM
Model Number 102
Event Date 10/01/2004
Event Type Injury Patient Outcome Life Threatening; Required Intervention
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. Treating neurologist indicated that the pt was experiencing normal fluctuations in seizure frequency and that the event was not related to the vns therapy.

Event Description
Vns pt had experienced an increase in seizure activity above pre-vns baseline frequency. The pt's family member reported that following an increase in programmed parameters, the pt had 7 seizures per day. Per-vns seizure frequency is documented as a being 3 seizures per day. Programmed parameters were decreased and the pt's seizure frequency dropped back to 3 seizures per day. The device was later programmed to off and the pt continued to have 2-3 seizures per day. Topamax was discontinued from the pt's drug regimen approximately six weeks prior to vns implant. Treating neurologist plans to program the device back to on.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=559917



Title: Re: Increase in seizures
Post by: dennis100 on November 29, 2011, 11:59:38 PM
Model Number 102
Event Date 11/12/2004
Event Type Injury Patient Outcome Life Threatening;
Event Description
Vns pt experienced an increase in seizure frequency after a increase in device normal mode output current setting. It was reported that pre-vns implant, the pt experienced 2-3 seizures per week. Normal mode output current was increased from 0. 25ma to 0. 50ma approximately three months post-implant and from 0. 50ma to 0. 75ma approximately two weeks later. After the increase to 0. 75ma, the pt reportedly began experiencing daily seizures. Normal mode output current was later increased to 1. 0ma, but there was no subsequent decline in seizure frequency. Treating neurologist indicates that the pt's seizure types have not changed and that the pt was not experiencing daily seizures, but approximately three seizures power week since the increase in device normal mode output current to 0. 75ma. Their had been no recent medication changes or environmental stimuli that may have contributed to the increase in seizure activity and the pt's health condition is not worsening. Neurologist indicated that the pt's seizures initially increased after the increase in normal mode output current to 0. 75ma, but that they have now subsided. No intervention is planned. Investigation to date has been unable to determine the cause of the reported increase in seizure activity.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=559968


Title: Re: Increase in seizures
Post by: dennis100 on November 30, 2011, 12:00:17 AM
Model Number 101
Event Date 01/01/2004
Event Type Injury Patient Outcome Life Threatening; Required Intervention
Event Description
Reporter indicated that vns patient has recently experienced a drastic increase in seizure activity. The patient indicated to they neurologist that "the vns was not working well" for them so they increased device duty cycle, lowered the patient dilantin dosage and added trileptol to the patient's drug regimen. The patient's seizure frequency then increased from 1 seizue frequency then increased from 1 seizure every other day to 4 seizure daily. The patient's family member reports that use of the magnet no longer works to abort the patient's seizures. Treating neurologist has since instructed the patient to discontinue the trileptol as he believes that may be the cause of the increased seizure frequency. Review of manufacturing records for both the pulse generator and the bipolar lead to revealed no anomalies that would adversely effect device performance. Investigation to date has been unable to determine whether the vns therapy caused or contributed to the reported increase in seizure activity or whether it was medication-related.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=559424



Title: Re: Increase in seizures
Post by: dennis100 on November 30, 2011, 02:32:04 AM
Model Number 102
Event Date 08/01/2004
Event Type Injury Patient Outcome Life Threatening; Required Intervention
Event Description
Reporter indicated that vns patient's seizures were worsening. It was reported that the patient initially experienced some seizure control with the vns therapy, but that now their seizures appears to be worsening. The patient has recently experienced flurries of seizures, one of which persisted even after diastat was administered, resulting in a visit to the hospital emergency room. Two-epileptic medications were subsequently added to the patient's drug regimen due to the worsening of seizures. There have been no adjustments to programmed parameters during this time. There were no clear increasing or precipitating factors noted, including fever or infection. The patient's mother reported that use of the magnet does not work to abort the patient's seizures. Personnel at the group home where the patient resides indicated that use of the magnet seemed to make the patient's seizures worse. Device diagnostic testing was within normal limits, indicating proper device function. Further follow-up revealed that the patient was doing well and was currently seizure-free and more coherent. Investigation to date has been unable to determine the cause of the reported events. Treating neurologist plan an x-ray to rule out pneumonia.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=558587



Title: Re: Increase in seizures
Post by: dennis100 on November 30, 2011, 02:32:47 AM
Model Number 102
Event Date 10/01/2004
Event Type Injury Patient Outcome Required Intervention;
Manufacturer Narrative
Reporter is incomplete because no reponse has been received to manufacturer's request for additional information from treating neurologist.

Event Description
Reporter indicated that vns patient has experienced a recent increase in seizure severity. It was reported that the patient experienced several seizures in one day and was told by neurologist to go to the hospital emergency room where patient was given valium and was stabilized. Treating neurologist then prescribed diastat. The patient reports that patient seizures were not as severe prior to vns implant or for more than one year after implant. The patient reports that patient usually has an aura before their seizures and that patient is usally able to abort the seizure with use of the magnet. With the recent increase in seizure severity, the patient reports that there is no warning and patient drops to the floor with thes seizure and hits their head. The patient started noticing a change in the severity of their seizures approximately two weeks after programmed parameters were last adjusted. The patient denies any medication changes, added stressor or other illness.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=558474



Title: Re: Increase in seizures
Post by: dennis100 on November 30, 2011, 02:33:33 AM
Model Number 102
Event Date 09/01/2004
Event Type Injury Patient Outcome Required Intervention; Life Threatening
Manufacturer Narrative
Report is incomplete because no response has been received to manufacturer's request for additional information from treating neurologist.

Event Description
Reporter indicated that vns patient has experienced an increase in seizure activity above pre-vns baseline frequency. It was reported that the patient experienced 1 seizure every 2-3 weeks before vns implant, but that since being implanted, patient is experiencing 1 seizure every week. The patient's physician had reportedly decreased their medications. The patient family member has pulled the patient out of school because patient has been falling with their seizures. The patient fell and injured their toe with one of their seizures. Investigation to date has been unable to determine whether the increase in seizure activity is related to the vns therapy or to the adjustment to the patient's anti-epileptic drug regimen.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=558485



Title: Re: Increase in seizures
Post by: dennis100 on November 30, 2011, 02:34:12 AM
Model Number 300-20
Event Date 01/01/2004
Event Type Malfunction Patient Outcome Life Threatening; Hospitalization Required Intervention
Event Description
Mfr received device tracking info from an apparent generator replacement surgery, on which a high lead impedance test result was documented for intraoperative device diagnostic testing, indicating possible device malfunction. Further follow-up revealed that the pt's generator was replaced due to suspected end of service, but that device diagnostic testing three months prior to generator replacement surgery had also resulted in high lead impedance test result, indicating possible device malfunction at that time. The elective replacement indicator was no, indicating that the generator had not reached end of service at that time. The pt reportedly indicated to treating neurologist that had not felt device stimulation for approximately ten months prior to generator replacement surgery. It was also reported that the pt had experienced an increase in seizure activity. Investigation to date has been unable to determine whether the increase in seizure activity was an increase above pre-vns baseline frequency or simply an increase above previous efficacy with the vns therapy. The pt does not recall any injury or trauma that may have damaged the ncp system. Review of the manufacturing records for both the original and the replacement pulse generators as well as the original bipolar lead revealed no anomalies that would adversely affect device performance. Lead break is suspected. Lead replacement surgery is planned for 90 days from date of generator replacement surgery at the recommendation of treating neurosurgeon.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=611984



Title: Re: Increase in seizures
Post by: dennis100 on November 30, 2011, 02:34:46 AM
Model Number 300-30
Event Type Malfunction
Event Description
Reporter indicated that device diagnostic testing at office visit resulted in high lead impedance reading (dc-dc code 7 and limit), indicating possible device malfunction. The elective replacement indicator was no, indicating that the generator had not reached end of service. The pt is reportedly experiencing an increase in seizure activity above previous efficacy with the vns therapy, but not above pre-vns baseline frequency. The pt had not suffered any recent injury or trauma that may have damaged the ncp system. Review of x-rays by treating neurologist did not reveal any obvious discontinuities in the ncp system. Review of manufacturing records for both the pulse generator and the bipolar lead revealed no anomalies that would adversely aeffect device performance. The pt underwent ncp system replacement surgery, during which it is believed that both the pulse generator and the bipolar lead were replaced. Lead break or generator/lead connection problem is suspected.

Event Description
Product analysis summary: the lead (model 300-30) was returned and analyzed. The condition of the portion of the lead, in general, is consistent with conditions that typically exist following an explant procedure. The lead pins showed evidence of a proper connection with the generator. A lead break was found during analysis. The appearance of one wire of the broken coil is characteristic of a stress-induced fracture. Due to metal dissolution and surface contamination the fracture mechanism on the other coil wires cannot be ascertained. It is believed that stimulation was present (break occurred during implant duration) as evidenced by the presence of pitting or electro-plating conditions observed on the broken coils wires. The cause of the break was not ascertained. The reported high impedance was due to a lead break. The reported increased seizures were likely due to the pt not receiving vns therapy due to a lead break. The concomitant device (pulse generator) was also analyzed. The pulse generator met the manufacturer's final electrical test specificatons. No performance anaomalies were noted. There is no indication that the reported lead high impedance, or increased seizures is related to the pulse generator.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=611968


Title: Re: Increase in seizures
Post by: dennis100 on November 30, 2011, 02:35:21 AM
Model Number 101
Event Date 11/02/2004
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.

Event Description
Reporter indicated that pt experienced a recent increase in seizure activity above pre-vns baseline frequency. The pt's family member reported that before vns implant, the pt experienced approx six seizures every three months, but pt had recently experienced six seizures in one day. The pt's family member reported that the pt had experienced great seizure control prior to the recent increase in seizure activity. It was reported that the pt had not suffered recent injury or trauma that may have damaged the ncp system, but that pt had lost their magents. A new set of magnets was shipped to the pt. The pt was seen by neurologist who increased their depakote dosage, but made no changes to device settings. Investigation to date has been unable to determine the cause of the reported event.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=558215



Title: Re: Increase in seizures
Post by: dennis100 on November 30, 2011, 02:35:56 AM
Model Number 102
Event Date 10/01/2004
Event Type Injury Patient Outcome Life Threatening; Hospitalization
Event Description
Reporter indicated that vns pt has been hospitalized on two occasions due to episodes of status epilepticus. The pt has had trouble sleeping since implant and the device settings have been adjusted twice. After each parameter adjustment, the pt experienced an episode of status epilepticus requiring hospitalization. After pt gets used to the stimulation, pt does very well and has good seizure control. Treating neurologist indicated that the events are related to stimulation and believes that most of the pt's seizures are psychogenic. No intervention is planned, but programmed parameters will not be further increased at this time. Investigation to date has been unable to determine the cause of the reported events.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=558248



Title: Re: Increase in seizures
Post by: dennis100 on November 30, 2011, 02:36:46 AM
Model Number 101
Event Date 11/01/2004
Event Type Malfunction Patient Outcome Life Threatening; Hospitalization Required Intervention
Event Description
Product analysis summary: the pulse generator met electrical test specifications. External visual inspection of the generator revealed no anomalies.

Manufacturer Narrative
H. 6. : per the pt physician told pt that their original generator was at end of service because they had gained weight. The physician reportedly told the pt that muscle and fat had grown over the generator, causing one of the lead connector pins to become disconnected from the generator, which drained the generator battery. Based on known device settings, the device should not have reached end of service for approximately 5. 32 more years under normal conditions of operation.

Event Description
Reporter indicated that vns pt was hospitalized due to an increase in seizure activity above pre-vns baseline frequency and that emergency room physicians could not communicate with their device. It was reported that the pt weight 90 pounds before vns implant, but that they had gained 60 pounds since implant. The pt denied any injury or trauma that may have damaged the ncp system. The pt underwent generator replacement surgery.

Event Description
Further follow-up revealed that the patient has been seizure free. The patient is very please with vns therapy.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=611937



Title: Re: Increase in seizures
Post by: dennis100 on November 30, 2011, 02:37:23 AM
Event Date 01/01/2004
Event Type Injury Patient Outcome Life Threatening;
Manufacturer Narrative
Report is incomplete due to the anonymous nature of the reported event. No response has been received to manufacturer's email reply to the patient.

Event Description
Reporter indicated that vns patient has been having "more seizures than ever and even double ones". The patient also was shaking as if patient were drunk. Investigation to date has been unable to determine the cause of the reported events.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=557483


Title: Re: Increase in seizures
Post by: dennis100 on November 30, 2011, 02:38:02 AM
Model Number 102
Event Date 10/01/2004
Event Type Injury Patient Outcome Life Threatening;
Manufacturer Narrative
Report is incomplete because no response has been received to manufacturer's requested for additional info from treating neurologist.

Event Description
Reporter indicated that vns pt had recently experienced an icrease in seizure activity above pre-vns baseline frequency. The pt reported does not feel magnet mode stimulation. The pt experienced a seizure while at their neurologist's office, during which both the pt and the neurologist swiped the device with the magnet. The seizure did not stop and progressed into a grand mal seizure. The pt was taken to the hosp e. R. Neurolgoist indicated that the pt had not suffered any recent injury or trauma that may have damaged the vns therapy system and that medications had recently been increased. Neurolgosit plans to perform device interrogation and diagnostic testing to confirm initiation of magnet mode stimulation with magnet use. Review of manufacturing records for both the pulse generator and the bipolar lead reveiwed no anomalies that would adversely effect device performance. Investigation to date has been unable to determine the cause of the reported increased in seizure activity.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=557488



Title: Re: Increase in seizures
Post by: dennis100 on November 30, 2011, 02:39:14 AM
Model Number 102
Event Date 10/01/2004
Event Type Injury Patient Outcome Life Threatening;
Manufacturer Narrative
Report is incomplete because no response has been received to mfr's requests for additional info from treating neurologist.

Event Description
Reporter indicated that vns pt has recently experienced an increase in seizure activity above pre-vns baseline. Pre-vns implant, the pt experienced one seizure every 48 hours and pt has now experienced three seizures in one day. It was reported that the pt has had an increase in anxiety since the family has just moved to a new home. The pt's family member also indicated that the pt has recently developed ear pain and has started touching their neck incision and saying that "its hot". The pt reportedly has some swelling behind their left ear and has recently experienced difficulty swallowing vitamins.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=557512


Title: Re: Increase in seizures
Post by: dennis100 on November 30, 2011, 02:39:50 AM
Event Type Injury Patient Outcome Life Threatening;
Manufacturer Narrative
Report is incomplete because no response has been received to mfr's requests for additional info from initial reporter.

Event Description
Reporter indicated that neurologist is treating two vns pts with clusters of myoclonic seizures who developed long tonic seizures after stimulation was initiated. These new seizure types reportedly worsened with increases to programmed device parameters. Investigation to date has been unable to determine the cause of the reported events.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=557562



Title: Re: Increase in seizures
Post by: dennis100 on November 30, 2011, 02:40:43 AM
Model Number 101
Event Date 01/01/2004
Event Type Injury Patient Outcome Life Threatening;
Manufacturer Narrative
Report is incomplete because no response has been received to manufacturer's requests for additional information from treating neurologist (via fax x2).

Event Description
Reporter indicated that vns pt was experiencing an increase in seizure activity. Investigation to date has been unable to determine whether the pt has experienced an increase in seizures above pre-vns baseline frequency, or simply an increase above previous efficacy with the vns therapy.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=557410



Title: Re: Increase in seizures
Post by: dennis100 on November 30, 2011, 02:41:27 AM
Model Number 101
Event Date 10/01/2004
Event Type Injury Patient Outcome Life Threatening;
Event Description
Reporter indicated that vns patient experienced an increase in seizure frequency and duration following an increase in stimulation duty cycle. It was reported that the patient's seizure frequency increased from 1-2 seizures per day to 5-6 seizure per day and that the duration increased from 10-15 seconds to 20-30 seconds. It was also reported that the patient's behavior became extreme during this time. Review of device programming history revealed no anomalies. Device diagnostic testing performed approximately one month post-implant was within normal limits,indicating proper device function at that time. Investigation to date has been unable to determine the cause of the reported event.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=557379




Title: Re: Increase in seizures
Post by: dennis100 on November 30, 2011, 02:04:32 PM
Model Number 102
Event Date 02/01/2005
Event Type Injury Patient Outcome Life Threatening; Required Intervention
Event Description
Pt experienced a flurry of seizures above pre-vns baseline frequency following an increase in programmed parameters. Normal mode output current was increased from 1. 0ma to 1. 25ma and that magnet mode output current was increased from 1. 25ma to 1. 5ma and that the pt experienced a flurry of seizures the following evening. There had been no medication changes at the time of the reported event. The pt's device settings were reduced back to the original values just before the seizure flurry event.

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 adolescerrls with partial onset seizures that are refractory to antiepileptic medications.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=586918



Title: Re: Increase in seizures
Post by: dennis100 on November 30, 2011, 02:05:33 PM
Model Number 300-20
Event Type Malfunction
Event Description
Reporter indicated tha pre-operative device diagnostic testing just prior to generator replacement surgery resulted in high lead impedance reading (dc-dc code 7 and limit), indicating possible device malfunction. It was reported that the pt was scheduled for generator replacement surgery due to suspected end of service. The elective replacement indicator was no, indicating that the generator had not reached end of service; however, a battery life estimation based on knwon device settings revealed that the battey was most likely nearing end of service (approx 2-3 months life remaining). Review of x-rays did not reveal any obvious discontinuities in the ncp system. Review of mfg records for both the pulse generator and the bipolar lead revealed no anomalies that would adversely affect device performance. The pt had not suffered any recent injury or trauma that may have damaged the ncp system. Both the lead and generator were replaced. Lead break is supected.

Event Description
It was further reported that the pt had experienced an increase in their seizures which suggest a device malfunction or the device reaching end of service. A portion (382mm) of the lead was returned for analysis. An analysis was performed on the lead portion that was returned. The lead portion returned passed continuity checks and the lead condition is consistent with conditions that typically exist following an explant procedure. The lead pins showed evidence that there was a proper mechanical and electrical connection betwen the lead pin and the pulse generator. Because the entire lead was not returned, the mfr cannot verify the reported high lead impedance report. Possible causes include design, durability, corrosion, trauma to the site or user error. The concomitant device (pulse generator) was also returned and analyzed. The pulse generator met final electrical test specifications. There is no indication that the reported high impedance was related to the pulse generator.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=587522



Title: Re: Increase in seizures
Post by: dennis100 on November 30, 2011, 02:06:13 PM
Event Date 01/21/2004
Event Type Injury Patient Outcome Disability;
Event Description
Pt had a vagus nerve stimulator manufactured by cyberonics installed in 2003 and activated a month later. Usage of this device is suspected to have caused pt to develop sleep apnea as a result of using this device. Device was installed in an attempt to control epileptic seizures. Sleep apnea that began after installation and activation of the device is believed to have led to as many or more seizures as before installation due to lack of sleep from the sleep apnea. Side effects of the vns were listed as possible increase in sleep apnea, but no mention is made that possible side effect of usage of the vbs included paralysis of the left vocal chord. Again, there is no mention of this as a possible side effect in any literature provided by cyberonics. Paralysis of vocal chords is one possible cause of sleep apnea and perhaps the paralysis is what is causing the sleep apnea. The physician who examined the pt indicated that the paralysis of left vocal chord will be permanent and so removal of the vns device would not be of benefit in relieving the situation. Permanent paralysis of the vocal chord is also not mentioned as a possible side effect of using the vns.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=586724



Title: Re: Increase in seizures
Post by: dennis100 on November 30, 2011, 02:06:57 PM
Model Number 300-20
Event Type Malfunction
Event Description
Device diagnostic testing at office visit resulted in high lead impedance reading (dc-dc code 7 and limit), indicating possible device malfunction. The elective replacement indicator was no, indicating that the generator had not reached end of service. The patient no longer experiences any voice change, facial flushing or cough with device stimulation. The patient reported that patient no longer felt device stimulation but that patient had not experienced any recent injury or trauma that may have damaged the ncp system. The patient recently experienced an increase in seizure activity; however, treating neurologist could not confirm as this is a new patient to him. Review of x-rays by treating neurologist did not reveal any obvious discontinuities in the ncp system. Review of manufacturing records for both the pulse generator and the bipolar lead revealed no anomalies that would adversely affect device performance. The patient's ncp therapy system (both lead and generator) were replaced. Lead break is suspected.

Event Description
Product analysis of the lead was completed. Product analysis summary: the condition of the returned portion of the lead, in general, is consistent with conditions that typically exist following an explant procedure. A coil break was identified on the lead assembly. Inspection of the coil performed at the identified break area, showed that one of the broken filars exhibit a characteristic appearance of a stress-induced fracture. However, the fracture mechanism could not be ascertained for the other filars. The fracture surfaces did not show any pitting or e lectro-plating conditions. It is unk whether energy was flowing through the coil at the time of the fracture. A fracture was the likely cause of the reported high impedance, stimulation not perceived, and increase in seizures. The cause of the break is unk. Possible causes of a lead fracture include: 1) mechanical failure; 2) implant technique (use of suture; no strain relief); 3) "twiddler" (twisting of the lead); 4) violent seizure; or 5) dr injury/accident 6) poor electrical connection. The concomitant (pulse generator) device was also returned and analyzed. The pulse generator is operating within the mfr's final electrical test specification. The pulse generator did not show any condition that would have contributed to the reported event.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=587535



Title: Re: Increase in seizures
Post by: dennis100 on November 30, 2011, 02:08:14 PM
Model Number 102
Event Date 02/01/2005
Event Type Injury Patient Outcome Life Threatening;
Event Description
Reporter indicated that vns pt was experiencing an increase in seizure activity. It was reported that has history of cluser and grand mal seizures, but that pt has been seizure-free with the vns therapy until recently. The pt reportedly experienced 2 cluster seizures one day and 1 cluster seizure the following day. It is not known whether the seizure increase is above pre-vns baseline frequency as the pt was visiting someone out of state at the time of the reported event. The initial reporter indicated that the pt is usually left in a wheelchair, but that pt had been up and walking more and that the increase in physical activity may have contributed to the increase in seizure frequency.

Manufacturer Narrative
Report is incomplete because no response has been received to mfr's requests for additional info from treating neurologist.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=584337



Title: Re: Increase in seizures
Post by: dennis100 on November 30, 2011, 02:09:13 PM
Model Number 102R
Event Date 02/01/2005
Event Type Injury Patient Outcome Life Threatening;
Event Description
Reporter indicated that vns patient was experiencing an increase in seizure activity. It was reported that the patient was having four seizures per day over their normal amount of daily seizures. Device diagnostic testing on the day that the patients current generator was impanted was within normal limits, indicating proper device function at that time. Based on known device settings, generator end of service is not likely. Investigation to date has been unable to determine if the cause of the reported increase in seizure activity or whether it is an increase above pre-vns baseline frequency or above previous efficacy with the vns therapy.

Manufacturer Narrative
Report is incomplete because no response has been received no manufacturer's requests for additional information from treating physician. 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.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=582347



Title: Re: Increase in seizures
Post by: dennis100 on November 30, 2011, 02:10:12 PM
Model Number 101
Event Date 01/01/2005
Event Type Injury Patient Outcome Life Threatening;
Manufacturer Narrative
Report is incomplete because no response has been received to manufacturer's requests for additional information from treating neurologist (via fax x2). H. 6. The vns therapy system is indicated for use as an adjuctive 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
Vns pt has recently experienced an increase in seizure activity. Investigation to date has been unable to determine whether the increase in seizure activity is above pre-vns baseline frequency. Device diagnostic testing approximately three months prior was within normal limits, indicating proper device function.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=582021


Title: Re: Increase in seizures
Post by: dennis100 on November 30, 2011, 02:11:09 PM
Model Number 102
Event Date 01/01/2005
Event Type Injury Patient Outcome Life Threatening;
Manufacturer Narrative
Report is incomplete because no response has been received to mfr's requests for additional info from treating neurologist.

Event Description
Reporter indicated that vns pt was experiencing an increase in seizure activity above pre-vns baseline frequency. Investigation to date has been unable to determine the cause of the reported event.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=581145



Title: Re: Increase in seizures
Post by: dennis100 on November 30, 2011, 02:12:10 PM
Model Number 100
Event Date 02/01/2005
Event Type Injury Patient Outcome Life Threatening;
Manufacturer Narrative
Report is incomplete because no response has been received to manufacturer's requests for add'l info from treating neurologist (via fax x2).

Event Description
Vns pt has experienced a recent increase in seizure activity. It is not known whether the increase in seizure activity is above pre-vns baseline frequency or above previous efficacy with the vns therapy. Results of device diagnostic testing are unk; however, it was reported that the elective replacement indicator was no, indicating that the generator had not reached end of service. Investigation to date has been unable to determine the cause of the reported increase in seizure activity

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=580767



Title: Re: Increase in seizures
Post by: dennis100 on November 30, 2011, 02:13:00 PM
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



Title: Re: Increase in seizures
Post by: dennis100 on November 30, 2011, 02:13:46 PM
Model Number 300-20
Event Date 01/26/2005
Event Type Injury Patient Outcome Life Threatening;
Manufacturer Narrative
Report is incomplete because no response has been received to mfr's requests for additional information from treating neurologist.

Event Description
Patient experienced an increase in seizure activity above pre-vns baseline frequency after undergoing physicial therapy. The pt reported that they had an "ultrasound" and that they believed that it may have disturbed their device. The pt reported that they underwent physical therapy twice in four days, during which they used heat and aggressive massage in their left neck area, upper shoulders, and upper back. The pt did not know the exact name of the physical therapy procedure and was not sure whether it included diathermy. Since the physical therapy, the pt feels pain to their left neck and feels as thought the device "fibrates in their chest". The pt reported that they do not feel normal mode stimulation 97% of the time, but that they do feel magnet mode stimulation. The pt reported that since the first physical therapy treatment, they have been having "microseizures" above their pre-vns baseline frequency. The pt planned to contact their neurologist for follow-up. 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 confirm the cause of the reported event.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=576815



Title: Re: Increase in seizures
Post by: dennis100 on November 30, 2011, 02:14:38 PM
Model Number 102
Event Date 01/01/2004
Event Type Injury Patient Outcome Life Threatening;
Manufacturer Narrative
Vns therapy system labeling lists dyspnea (difficulty breathing, shortness of breath) and stomach discomfort as potential adverse events possibly associated with surgery or stimulation.

Event Description
Since vns implant, the patient has experienced an increase in seizure activity above pre-vns baseline frequency. It was reported that the patient experience 1 seizure per week before vns implant and now has up to 3 seizures per week. Treating neurologist reportedly believed that the programmed output current may have been too high and subsequently reduced it, after which the patient experienced shortness of breath. The patient also reports that since the decrease in output current setting, patient has pain in their stomach, described as a feeling as if "someone is kicking patient in the stomach and knocking the wind out of them. Additionally, the patient reports that swiping the device with the magnet does not abort or reduce their seizures and that more magnet activations are showing up on device history than patient claims to have initiated. Treating neurologist has reduced device pulse width setting and referred the patient to their family physician as patient does not believe that the events are related to the vns. Device diagnostic testing was within normal limits, indicating proper device function. Further follow-up with treating neurologist revealed that the patient is doing better, but that neurologist now believes that the reported events might possibly be related to the vns. 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 the cause of the reported increase in seizure activity.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=574720



Title: Re: Increase in seizures
Post by: dennis100 on November 30, 2011, 02:15:22 PM
Model Number 101
Event Date 01/01/2004
Event Type Injury Patient Outcome Life Threatening;
Event Description
Patient has experienced a recent increase in seizure activity. Pre-vns seizure frequency is documented as being 2-4 generalized tonic-clonic seizures per month. The patient reportedly experienced 7-8 seizures per month. Additionally, the patient reports that sometimes does not feel device stimulation. Device diagnostic testing was within normal limits, indicating proper device function; however, treating physician did experience difficulty communicating with the patient's device through the patient's clothing. Device communication performed with the programming system in direct contact with the patient's skin was performed without difficulty. Pocket depth was ruled out as a possible cause of the communication difficulties because the patient is thin and the generator is easily palpable. The elective replacement indicator was no indicating that the generator had not reached end of service. The patient thought that they remembered feeling normal mode stimulation approximately one week prior to this office visit and could not remember the last time that patient felt magnet mode stimulation. The patient reports that they did not feel magnet mode stimulation when they last swiped the device approximately one week prior. Normal mode output current was programmed to 2. 5ma with magnet mode at 2. 75ma, but the patient could not tolerate the higher setting. Normal mode output current was decreased back to 2. 5ma. It was reported that there had been no medication changes or environmental stimuli that may have contributed to the increase in seizure activity. The patient's overall health condition is reportedly not worsening and seizure types had not changed. 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 the cause of the reported increase in seizure activity.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=574699



Title: Re: Increase in seizures
Post by: dennis100 on November 30, 2011, 02:15:58 PM
Model Number 101
Event Date 01/01/2004
Event Type Injury Patient Outcome Life Threatening; Required Intervention
Event Description
Pt has experienced an increase in seizures. Device diagnostic testing was within normal limits, indicating proper device function. The elective replacement indicator was no, indicating that the generator had not reached end of service. Pt indicated that pt can no longer feel the device normal mode stimulation and the magnet is no longer as effective as it used to be. Pt is less alert and the post ictal period after a seizure has become worse. Neurologist increased both the normal mode output current and magnet mode output current by 0. 25ma. Pt experienced approx a 60% reduction in seizures with vns therapy prior to the recent increase in seizures. Based on known device settings, it is not likely that the generator has reached end of service. Investigation to date has been unable to determine whether the increase in seizures is above the pt's pre-vns baseline frequency or an increase above previous efficacy with vns therapy. The cause of the event is unk, investigation is ongoing.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=574733


Title: Re: Increase in seizures
Post by: dennis100 on November 30, 2011, 02:16:38 PM
Model Number 300-20
Event Date 01/01/2004
Event Type Injury Patient Outcome Disability; Required Intervention
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
Vns pt has suffered a severe decline in mental and physical function over the past year. It was reported that the pt is unable to talk and is virtually unable to walk, which they reportedly never had problems with in the past. Additionally, it was reported that the pt's seizure pattern had changed from nocturnal seizures to seizures both in the day and at night time. It was reported that, beginning 4 months post-implanted and lasting for approx two years, the pt had excellent results from the vns therapy. During this time, the pt had very few seizures and a marked increase in alertness, communication skills and learning. The pt's condition has worsened over the past year to the point that they experiences multiple tonic-clonic seizures per day and has suffered a severe decline in mental and physical function. Device diagnostic testing has reportedly been within normal limits on four separate occasions during this time period, indicating proper device function. Review of x-rays has not revealed any obvious discontinuities in the ncp system. Adjustments programmed parameters have not resulted in improvement of the pt condition. The pt's family members have indicated that the decline in the pt's condition seemed to correspond directly to a period of time just over one year ago and when they began to pull at their neck in the area of the lead electrodes. Treating neurologist has recommended starting the pt on keppra.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=573082



Title: Re: Increase in seizures
Post by: dennis100 on November 30, 2011, 02:17:16 PM
Model Number 101
Event Type Injury
Patient Outcome Life Threatening; Hospitalization Required Intervention
Manufacturer Narrative
Vns therapy system labeling indicates that the safety and efficacy of this therapy have not been systematically established for use in patients with history of previous therapeutic brain surgery.

Event Description
Vns patient had experienced an increase in seizures. It was reported that the patient was later hospitalized for seizure control for approximately three days. During hospitalizzation the patient's medication were changed. Phenobarbital and valium were discontinued and levetiracetam was started. It was reported that the patient became more alert and ate voraciously after being taken off the previous medications. It was also reported that device settings were also changed during hospitalization. The normal mode output current was increased from 1. 0ma to 1. 5ma and magnet mode output current was increased from 1. 0ma to 1. 75ma without any apparent side effects. Upon discharge from the hospital the patient was experiencing approximately two to three seizures at night and none during the day. X-rays reviewed by neurosurgeon did not identify any obvious discontinuities with the ncp system. Investigation to date has been unable to determine whether the increase in seizures is above the patient's pre-vns baseline frequency or simply an increase above previous efficacy with vns therapy.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=572551



Title: Re: Increase in seizures
Post by: dennis100 on November 30, 2011, 02:18:00 PM
Model Number 102
Event Date 11/01/2004
Event Type Injury Patient Outcome Life Threatening; Required Intervention
Manufacturer Narrative
H. 6: vns therapy system states that the safety and efficacy of this therapy have not been systematically established for use in pts with history of previous therapeutic brain surgery.

Event Description
Vns pt was experiencing an increase in seizures activity above pre-vns baseline frequency. Before vns implant, the pt experienced 6-8 seizures per month and that for the past two months pt has experiencing 20-22 seizures per month. Seven weeks before, the pt's family member indicated that there had been marked improvement in the pt's seizure control with the vns therapy. The pt's family member reported at that time that pt still had seizures about once a week with the vns therapy but that they used to have them every day. Treating neurologist indicated that the temporary increase in seizure activity was possibly related to klonopin withdrawal and was not related to the vns therapy. Klonopin was withdrawn from the pt's drug regimen due to excessive drowsiness. Topamax dosage has since been increased from 250mg per day. Neurologist indicated that the pt's overall health condition was not worsening and that their seizure types had not changed. There was reportedly no environmental stimuli that could have contributed to the increase in seizure activity.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=569952



Title: Re: Increase in seizures
Post by: dennis100 on November 30, 2011, 02:18:39 PM
Event Date 01/01/2004
Event Type Injury
Patient Outcome Life Threatening;
Manufacturer Narrative
Report is incomplete due to the anonymous nature of the reported event. No response has been received to mfr's request for additional info from initial reporter (via email x1).

Event Description
Reporter indicated that vns pt has experienced a recent increase in seizure activity. It was reported that the vns therapy has been "a miraculous solution" to the pt's uncontrolled epilepsy. The pt's family member indicated that they had concerns about whether the pt's generator was nearing end of service. Investigation to date has been unable to determine whether the reported event is an increase above previous efficacy with the vns therapy or an increase above pre-vns baseline frequency.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=569965



Title: Re: Increase in seizures
Post by: dennis100 on November 30, 2011, 02:19:19 PM
Model Number 101
Event Date 11/01/2004
Event Type Injury Patient Outcome Life Threatening;
Manufacturer Narrative
Report is incomplete because no response has been received to manufacturer's requests for additioonal information from treating neurologist.

Event Description
Reporter indicated that vns pt has experienced a recent increase in seizures. It was also reported that device normal mode stimulation has never stopped the pt's seizures; therefore, device normal mode output current was decreased to 25ma at the pt's request. The pt reported that swiping the magnet during a seizure occasionally stops the pt's seizures; therefore, magnet mode output current was left programmed to 2. 50ma. The pt has intractable seizures and has discussed right temporal lobe surgery with their neurologist since pt has not experienced efficacy with vns therapy. Investigation to date has been unable to determine whether the increase in seizures is above the pt's pre-vns baseline frequency

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=568333



Title: Re: Increase in seizures
Post by: dennis100 on November 30, 2011, 02:20:31 PM
Model Number 101
Event Date 12/01/2004
Event Type Malfunction Manufacturer Narrative
Ncp system labeling recommends interrogating the pulse generator as the last step of any programming session to verify correct settings for each parameter.
Event Description
Patient's device may not be functioning properly and the patient had experienced an increase in seizure activity, resulting in an emergency room visit. The patient was taken to the hospital emergency room due to "horrible seizures and drop attacks" and use of the magnet did not shorten or abort their seizures as it had in the past. It was reported that the patient was not able to feel device stimulation during this time. The patient's family member reported that the patient did not cough as they usually did when their device was swiped with the magnet before going to the hospital emergency room. Device diagnostic testing was within normal limits both at office visit ten days prior and during emergency room visit at the time of the event, indicating proper device function. After device diagnostic testing was performed during the emergency room visit, the patient's device was swiped with the magnet and they responded with a cough, indicating that magnet mode stimulation had been initiated. The patient was reportedly able to feel device stimulation again after leaving the hospital emergency room, but their family member reported that 24 hours later, swiping the device with the magnet did not elicit a coughing response from the patient and the family member reported that use of the magnet does not seem to stimulate the patient's nerve right away and that it takes approximately 45 minutes for the patient to feel stimulation after swiping the device with the magnet. It was reported that the patient was seen by a chiropractor a few weeks prior to the emergency room visit and that the chiropractor worked on their neck area. The patient reportedly felt that the chiropractor was "too aggressive," but their family member does not believe that the chiropractor caused any damage to the ncp system. The patient underwent generator replacement surgery at their family member's request, after which they reportedly continued not to feel device stimulation. Device diagnostic testing of suspect device just prior to explantation was within normal limits, indicating proper device function. Before explanting the suspect generator, the surgeon confirmed that the lead connector pins were properly secured. Device diagnostic testing of replacement generator both inside and outside the pocket was also within normal limits, indicating proper device function and ruling out a potential malfunction of the original lead. The patient's replacement generator was programmed to on at the time of implant and was set to the same settings that their explanted device had been programmed to (2. 0ma normal mode output current and 2. 25ma magnet mode output current). The day after surgery, the patient attempted to initiate magnet mode stimulation of the replacement generator and was still unable to feel device stimulation. At office visit two days later, both normal mode and magnet mode output currents were increased to 2. 25ma nad 2. 5ma respectively, after which the patient immediately felt normal mode stimulation. The patient swiped the deivce with magnet and experienced their typical coughing response. It is believed that the patient had simply become accustomed to stimulation at the lower settings since they have been receiving the vns therapy for almost 7 years. Evoked potential monitoring confirmed device stimulation at programmed intervals and device diagnostic testing was within normal limits, indicating proper device function. Treating neurologist increased device duty cycle from 16% to 25% by decreasing off time from 3 minutes to 1. 8 minutes in an effort to regain seizure control, but left the normal mode and magnet mode output currents set to previously prescribed settings (2. 0ma and 2. 25ma respectively). Review of manufacturing records for both the pulse generator and the bipolar lead revealed no anomalies that would adversely effect device performance. Review of device programming history for the explanted generator revealed that an interrupted lead test occurred at office visit two weeks before the emergency room visit resulting in a change in device settings from prescribed parameters (normal mode: 2. Ma output current, 30hz frequency, 500u pulse width, 30 seconds on, 3 minutes off; magnet mode: 2. 25ma output current, 500u pulse width, 60 minutes off; magnet mode: 1. 0ma output current, 500u pulse width, 30 seconds on) as expected. The patient's device was not interrogated at the conclusion of the office visit to confirm device settings. The inadvertent change in settings resulted in a reduction in duty cycle from 16% to 0. 94%. At subsequent office visit five days later, device interrogation revealed that programmed settings were not the same as what was prescribed (lead test settings instead of prescribed settings). The device was reprogrammed to prescribed settings at this office visit. Nine days after reprogramming the device to prescribed settings, the patient was seen in hospital emergency room due to the reported "horrible seizures and drop attacks. " investigation to date has been unable to conclusively determine whether the explanted generator was functioning properly or whether the inadvertent change to device settings as a result of user error was the cause of the reported event/suspected device malfunction.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=574784



Title: Re: Increase in seizures
Post by: dennis100 on November 30, 2011, 02:21:26 PM
Model Number 302-20
Event Date 11/16/2004
Event Type Injury Patient Outcome Life Threatening; Disability Manufacturer Narrative
H. 6. Vns therapy system labeling lists voice alteration (hoarseness) and left vocal paralysis as potential adverse events possibly assoicated with surgery or stimulation.

Event Description
Reporter indicated that vns pt has experienced an increase in both severity and frequency of seizures since implant. Additionally, the pt reports significant hoarseness more than one month post-implant, for which pt was referred to an ent for further evaluation. Pre-vns seizure frequency is documented as being more than 90 seizures per month. Post-vns seizures frequency is unknown at this time. Treating neurologist indicated that the pt's seizure types had not changed and that there were not medication changes that may have contributed to the increase in seizure intensity frequency. Neurologist indicates that pt believes that the reported events are related to the vns and that the pt's condition is "not good. " further investigation revealed that the implanting surgeon contacted device manufacturer during initial implant surgery requesting guidance in identifying the vagus nerve. The surgeon indicated at that time that pt had isolated a large nerve that pt suspected was the vagus nerve and that the nerve was superficial to the carotid artery, which was not the typical location. Investigation to date has been unable to determine the cause of the reported increase in sezure severity/frequency or whether the pt has been diagnosed with vocal cord paralysis.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=566498



Title: Re: Increase in seizures
Post by: dennis100 on November 30, 2011, 02:22:06 PM
Model Number 100
Event Date 12/19/2004
Event Type Injury Patient Outcome Life Threatening; Required Intervention
Event Description
Vns pt experienced an increase in seizure activity above pre-vns frequency. The pt recently experienced 3 seizures in one day and nothing pt's family member did would stop the seizures. The pt is reportedly scheduled for generator replacement surgery due to approching end of service. The pt was hospitalized five days later due to elevated temperature (103 degrees), at which time it was reported that their tegretol level was high. Tegretol was discontinued during their hosp stay. The reason for the fever is unk. The reason for elevated tegretol level is presumed to be the combination of tegretol and carbamazepine er. The pt is scheduled for generator replacement. Review of mfg records for both the pulse generator and bipolar lead revealed no anomalies that would adversely effect device performance. Investigation to date has been unable to confirm the cause of the reported increase in seizure activity.

Event Description
Product analysis summary: no anomalies were detected during external visual inspection of the generator. Bench testing confirmed the unit would not interrogate. Visual inspection of the module and battery revealed a portion of what appeared to be bristle or brush fiber. The fragment measures 3mm in length and is non-conductive. No other anomalies or contamination were observed. The battery voltage measured 1. 647 volt in circuit. This voltage is below the 2. 2 volt low battery operation indicated for the generator per electrical test specification. The battery was removed and a power supply (adjusted to 2. 2 volts) was inserted into the circuit. The serial number was restored and the module interrogated and programmed properly. The device programming history was reviewed. A number of possible errors and/or conflicts preventing an accurate longevity prediction were noted in the data. Three "most likely" predictions were calculated using parameters that indicated long-term settings. The settings were calculated for the total implant time. In each case, the actual implant time exceeds the predicted longevity. The caged module met electrical test specifications. The reported increase in seizures was likely due to generator end of service.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=566155




Title: Re: Increase in seizures
Post by: dennis100 on November 30, 2011, 02:22:42 PM
Model Number 102R
Event Date 07/01/2004
Event Type Injury Patient Outcome Life Threatening;
Manufacturer Narrative
Report is incomplete because no response has been received to manufacturer's request for additional information from treating neurologist.
Event Description
Reporter indicated that vns pt has experienced an increase in seizure activity above pre-vns baseline frequency since generator replacement surgery. The pt plans to follow-up with their neurolgoist for device diagnostic testing. Pre-vns seizure frequency is unknown. Previous seizure frequency with the vns therapy (prior to generator rpelacement surgery) is documented as being 1 seizure every six months. The pt reports their current seizure frequency since generator replacement surgery to be "many more than pt has had in their life. " investigation to date has been unable to determine the cause of the reported increase in seizure frequency.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=566138


Title: Re: Increase in seizures
Post by: dennis100 on November 30, 2011, 02:23:37 PM
Model Number 101
Event Date 01/01/2004
Event Type Injury Patient Outcome Life Threatening;
Manufacturer Narrative
Report is incomplete because no response has been received to manufacturer's requests for additional information from treating epileptologist.

Event Description
Reporter indicated that vns pt was experiencing an increase in seizure activity and that pt could no longer feel magnet mode stimulation. Epileptologist swiped the pt's device with the magnet and confirmed that the magnet activation was recorded in device history. Device diagnostic testing (lead test) was within normal limits, indicating proper device function; however, epileptologist indicated that normal mode test yielded some type of error message. The elective replacement indicator was no, indicating that the generator had not reached end of service. Epileptologist plans to bring the pt back in to the office and repeat device diagnostic testing with help from manufacturer in troubleshooting any error messages. Investigation to date has been unable to determine whether the increase in seizure activity is an increase above pre-vns baseline frequency or simply an increase above previous efficacy with the vns therapy.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=563462



Title: Re: Increase in seizures
Post by: dennis100 on November 30, 2011, 02:24:14 PM
Model Number 102
Event Date 11/01/2004
Event Type Injury Patient Outcome Life Threatening;
Manufacturer Narrative
H. 6. 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 previous therapeutic brain surgery.

Event Description
Reporter indicated that vns pt was experiencing an increase in seizure activity. The pt fell approximately four months prior and subsequently had to go to the hospital (reference medwatch report 1644487-2003-00486/03). Treating physician at that time reportedly indicated to the pt that their vns therapy system was "ok". The pt suffered another fall approximately three months later, for which pt did not go to the hospital. The pt reports that since the latter fall, pt has experienced an increase in seizure activity and that their seizures seem to be getting stronger. The pt plans to follow-up with their neurologist for device diagnostic testing. Investigation to date has been unable to determine whether the increase in seizure activity is an increase above pre-vns baseline frequency or simply an increase above previously efficacy with the vns therapy.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=563542



Title: Re: Increase in seizures
Post by: dennis100 on November 30, 2011, 02:24:50 PM
Model Number 101
Event Date 01/01/2004
Event Type Injury Patient Outcome Life Threatening;
Event Description
Reporter indicated that vns pt was experiencing an increase in seizure activity above previous efficacy with the vns therapy. Investigation to date has been unable to determine whether the increase in seizure activity is also an increase above pre-vns baseline frequency. It was reported that the vns therapy, the pt typically experienced 2-4 seizures per month, usually around the time of her menstrual cycle. The pt now experiences two seizures in one day. The pt's device has not been checked in 2 - 3 years. The pt has moved since the last time her device was checked. The pt now lives 70 miles away from the nearest neurologist and is without transportation.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=563260


Title: Re: Increase in seizures
Post by: dennis100 on December 01, 2011, 12:00:18 PM
Model Number 102
Event Date 02/01/2005
Event Type Injury Patient Outcome Required Intervention;
Event Description
Reporter indicated that pt's seizure frequency and severity have increased since vns implant. It was reported that the pt originally experienced an increase in seizure activity when the device was initially programmed to on; however, the pt was doing better after a parameter adjustment. Treating neurologist indicated that the pt began to experience another increase in seizure frequency after an increase in programmed parameters. The increase in seizure activity is described as clusters of seizures. Programmed parameters were reduced after which treating neurologist received no further complaints of increased seizure activity from the pt's family. Neurologist has scheduled a thyroid test as the pt's thyroid medication had been reduced during the time of the increase in seizure activity. Other medication changes that may have contributed to the increase in seizure activity include weaning the pt off of topamax, decreasing carbatrol dosage and increasing depakote dosage. Neurologist plans to see the pt again in one month.

Event Description
The exact cause of the increase in seizures cannot be determined; however, the increase was likely due to a combination of medication changes and the vns therapy programming changes.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=607999



Title: Re: Increase in seizures
Post by: dennis100 on December 01, 2011, 12:01:15 PM
Model Number 102R
Event Date 01/01/2005
Event Type Injury Patient Outcome Life Threatening;
Manufacturer Narrative
Report is incomplete because no response has been received to manufacturer's requests for additional information from treating neurologist.

Event Description
Reporter indicated that vns pt has experienced an increased in seizure strength since undergoing generator replacement surgery. It was reported that the strength of the pt's seizures had increased to the point that pt recently fractured a rib and an ankle during a seizure. Investigation to date has been unable to confirm the cause of the reported event.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=608046



Title: Re: Increase in seizures
Post by: dennis100 on December 01, 2011, 12:01:57 PM
Model Number 102
Event Date 01/01/2005
Event Type Injury Patient Outcome Life Threatening;
Event Description
Further follow-up revealed that the pt began experiencing "constant choking". Neurologist reduced the device pulse width to try and help alleviate the pt's side effects. It is unknown at this time whether or not the reduction in device pulse width alleviated the pt's side effects.

Manufacturer Narrative
Report is incomplete because no response has been received to mfr's requests for additional information from treating neurologist.

Event Description
Reporter indicated that vns patient has experienced an increase in seizure frequency. The pt has been feeling short of breath, even wtih inactivity and that their left arm occasionally twitches. The pt also reports feeling as if their whole chest is burning and itching. The pt has been seen by treating neurologist on two occasions due to the aforementioned events and that neurologist may have adjusted device settings at these office visits. The pt's neurologist instructed pt to relax and to calm down because pt is anxious.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=608260



Title: Re: Increase in seizures
Post by: dennis100 on December 01, 2011, 12:02:49 PM
Model Number 102
Event Date 03/01/2005
Event Type Injury Patient Outcome Life Threatening; Required Intervention
Event Description
Reporter indicated that vns pt experienced an increase in seizure activity above pre-vns baseline frequency after stimulation was initiated. It was reported that the pt experienced between 5-7 seizures per month before vns implant, but that during the five weeks that their device was programmed to on they experienced over 20 seizures. It was reported that the pt's seizure type had not changed and that there had been no recent medication changes or environmental stimuli that may have contributed to the increase in seizure activity. The pt's device was programmed to off, after which their seizure frequency has returned to pre-vns baseline levels. The pt plans to have the device explanted.

Manufacturer Narrative
H. 6. Info to date suggests that the vns therapy may have contributed to an increase in seizure frequency for unk reasons.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=606874



Title: Re: Increase in seizures
Post by: dennis100 on December 01, 2011, 12:03:49 PM
Model Number 101
Event Date 01/01/2005
Event Type Injury Patient Outcome Life Threatening; Hospitalization Required Intervention
Event Description
Product analysis for the pulse generator was completed. Product analysis summary: battery longevity using the limited known device parameters concluded that the battery still had approximately 6 months before reaching end of service. The device did not reach end of service. The pulse generator met the mfr's final electrical test specifications. No anomalies were noted that would have contributed to the reported increased seizures, lack of efficacy, and end of life events.

Manufacturer Narrative
H. 6. Ncp system labeling states that the safety and efficacy of this therapy have not been systematically established for use in patients with history or previous therapeutic brain surgery.

Event Description
Reporter indicated that vns patient has experienced a recent increase in seizure activity above pre-vns baseline frequency. Based on known device settings, it is likely that the original generator was approaching normal end of service. The patient underwent generator replacement surgery due to suspected end of battery life and is reportedly doing well afterwards. Before the generator replacement surgery, the patient's family member reported that the patient seemed to lose efficacy after being at the same settings for a period of time. The patient's family member indicated that another anti-epileptic meidcation had been added to patient's drug regimen during this time (topamax) and that programmed parameters were recently "cut in half". It was reported that after the reduction in parameters, the patient did well for a couple of months.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=604080



Title: Re: Increase in seizures
Post by: dennis100 on December 01, 2011, 12:04:39 PM
Model Number 102
Event Date 02/01/2005
Event Type Injury Patient Outcome Life Threatening;
Manufacturer Narrative
Report is incomplete because no response has been received to manufacturer's requests for additional information from treating neurologist.

Event Description
Reporter indicated that vns pt has experienced an increased in seizure activity above pre-vns baseline frequency. It was reported tha there had been recent medication changes, but it is known whether these changes occurred before or after the increase in seizure activity. Investigation to date has been unable to determine the cause of the reported event.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=599877



Title: Re: Increase in seizures
Post by: dennis100 on December 01, 2011, 12:05:35 PM
Model Number 102
Event Date 03/01/2005
Event Type Injury
Patient Outcome Life Threatening; Required Intervention
Manufacturer Narrative
Report is incomplete because no response has been received to manufacturer's requests for additional information from original neurologist (via fax x2). H. 6: vns therapy system labeling lists dysphagia pharyngitis and voice alteration (hoarseness) as potential adverse events possibly associated with surgery of stimulation.

Event Description
Reporter indicated that vns patient has experienced difficulty swallowing, pain in their throat, hoarseness and an increase in seizure activity over two weeks time. It was reported that the difficulty swallowing was continuous and not just with stimulation. The patient has temporarily discontinued stimulation by placing the magnet over the device, but his did not alleviate the swallowing difficulties. The patient reported that they had been experiencing pme seizure per month with the vns, but that they were now experiencing one seizure per week. It is unknown whether this is an increase an increase above pre-vns baseline seizure frequency. The patient's last parameter adjustment was approximatley three months prior, at which time the normal mode output current was increased to 0. 50ma. Treating neurologist reduced normal mode output current to 0. 25ma and reportedly decreased the frequency and pulse width setting as well. The patient was referred to an ent for further evaluation. The patient was seen by treating neurologist for the first time since moving from one state to aother. The patient reportedly plans to follow-up with their original neurologist in the other state. Device diagnostic testing approximately six months prior was within nornal limits, indicating proper device function at that time. Investigation to date has been unable to determine the cause of the reported events,.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=596474



Title: Re: Increase in seizures
Post by: dennis100 on December 01, 2011, 12:06:24 PM
Model Number 100
Event Type Injury Patient Outcome Life Threatening; Required Intervention
Manufacturer Narrative
Report is incomplete because no reponse has been received to manufacturer's requests for additional information from treating neurologist (via fax x2).

Event Description
After contacting the patient's family member to inform them that the patient's device may be nearing end of life, the patient's family member reported that the device had been programmed to off for some time because if caused the patient's seizures to increase. There are no plans to explant/reimplant at this time.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=596419



Title: Re: Increase in seizures
Post by: dennis100 on December 01, 2011, 12:07:14 PM
Model Number 101
Event Date 01/01/2003
Event Type Injury Patient Outcome Life Threatening; Required Intervention
Event Description
Reporter indicated that vns patient experienced an increase in seizure activity approximately three months post-implant. The patient had reportedly been under stressful situations and stated that things were getting better. Two and one-half months later, the patient still reported more seizures since vns implant. Twenty months later, the patient reported confusion and memory problems that were believed to be related to the vns therapy. The patient continues to have seizures "quite frequently" and treating neurologist does not know whether it is an increase above pre-vns baseline frequnency because this has been a continuous problem during their therapy. The patient also complained of "shocks" to their head, blurred vision and muscle contractions to their right leg. The patient's device was programmed to off pending an mri to rule out other medical possiblities. Review of manufacturing 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 that cause of the reported events.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=596488


Title: Re: Increase in seizures
Post by: dennis100 on December 01, 2011, 12:07:59 PM
Model Number 101
Event Date 01/01/2005
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.

Event Description
Vns pt was experiencing an increase in seizure activity. There has reportedly been no changes to the pt's drug regimen during this time. Device diagnostic testing was within normal limits, indicating proper device function. The normal mode test resulted in dc-dc code 4 with output status ok, indicating that the generator was able to deliver the vns therapy as programmed (2. 0ma normal mode output current). The elective replacement indicator was no, indicating that the generator had not reached end of life. Treating neurologist plans to adjust programmed parameters in an effort to achieve better efficacy with the vns therapy. Investigation to date has been unable to determine whether the increase in seizures acitivity was above pre-vns baseline frequency.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=594171



Title: Re: Increase in seizures
Post by: dennis100 on December 01, 2011, 12:08:56 PM
Event Date 03/01/2005
Event Type Injury Patient Outcome Life Threatening; Required Intervention
Manufacturer Narrative
Report is incomplete because no response has been received to manufacturer's requests for additional information from treating neurologist (via fax x2) or from pt (via telephone x1). Additionally, device-tracking information was not forwarded to manufacturer after implant.

Event Description
Vns therapy was experiencing an increase in seizure activity. The pt reported that he began to experience headaches approximately 1 1/2 weeks after stimulation was initiated and that the headaches are new for them. The pt also reported that they have been "shaking a lot". The pt indicated that when the device was first programmed to on, it was set to stiumlate once every 30 minutes. The pt reportedly noticed over time that the stimulation cycles appeared to be varying from the programmed pattern. The pt reported that the off time seemed to increase to every 40 minutes, then 45 minutes, and then every 50 minutes. A follow-up visit, the device was reprogrammed to stimulate once every 60 minutes. Since the programmed adjustment to off time, the pt reports that they have experienced pain in their throat with stimulation and that they are significantly bothered by it. The pt plans to follow-up with treating neurologist again and is considering changing neurologists so that they can have more "one-on-one" time with their treating physician. Investigation to date has been unable to determine whether the increase in seizure activity is above pre-vns baseline frequency.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=593931



Title: Re: Increase in seizures
Post by: dennis100 on December 01, 2011, 12:09:53 PM
Event Date 03/16/2005
Event Type Injury
Patient Outcome Life Threatening; Hospitalization
Event Description
When the patient's device was programmed on, the patient went home and subsequently experienced complex partial seizures status. The patient was instructed to place the magnet over the generator to deactivate the device. However, the patient reportedly continued to have seizures. The patient went back to the doctor's office and diastat was administered and the device was prograamed off. The physician reported that he plans to turn the device on at a lower setting and a longer off time. In 2005 they were turned on at 0. 5ma current, on time of 30 seconds, off time 5 minutes. The patient went home, had complex partial seizures status. Placed the magnet over the device to turn the stimulation off, but the patient continued to have complex partial seizures status. The patient was instructed to come to the physician's office where diastat was administered and the vns device was programmed off. It was further reported that the status resolved after the vns was turned off and diastat was administered. The physician also indicated that the event was related to the vns and the change in seizure frequency was above the patient's pre-vns seizure activity. The vns was deactivated for approximately 10 days after this event and was turned back on at. 25 ma output, 30 seconds on and 30 minutes off. There is no further information at this time as to how the patient is doing since the device was reactivated. The likely cause of the event was the initial device stimulation.

Event Description
Further follow-up revealed that the patient has experienced a reduction in seizures since programming the device back to on. It was reported that the patient is taking more and that this behaviour is good.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=591659



Title: Re: Increase in seizures
Post by: dennis100 on December 01, 2011, 12:10:46 PM
Event Date 01/01/2005
Event Type Injury
Event Description
Further follow-up revealed that the pt is currently doing well. Neurologist indicated that the increase in seizures was not an increase above the pt's pre-vns baseline frequency. Neurologist reported that an increase in tegretol possibly caused the pt's increase in seizures, and that the ncp system was not related to the increase. The pt's tegretol dosage has been decreased and device settings were changed (exact changes unk).

Manufacturer Narrative
Report is incomplete because no response has been received to manufacturer's requests for additional information from treating neurologist, including patient and product information. Neurologist has cited hipaa regulations as reason for not responding to manufacturer's request for additional information.

Event Description
Reporter indicated that vns patient's seizures "are getting worse". It was reported that device diagnostic testing was within normal limits, indicating proper device function. The elective replacement indicator was no, indicating that the generator had not reached end of life. Investigation to date has been unable to determine whether the patient has experienced an increase in seizure activity above pre-vns baseline frequency.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=591454




Title: Re: Increase in seizures
Post by: dennis100 on December 01, 2011, 12:11:42 PM
Model Number 101
Event Date 03/01/2005
Event Type Injury Patient Outcome Life Threatening;
Event Description
Further follow up revealed that the patient underwent generator replacement surgery due to suspected end of service. Battery life estimate was calculated using available device program history. Battery life analysis indicated that the generator should not reach end of service for another 5. 45 years.

Manufacturer Narrative
Report is incomplete because no response has been received to manufacturer's request for additional information from treating neurologist. H. 6. The vns therapy system is indicated for use as an adjunctive therapy in reducing the frequency of seizures in adults and adolescents over 12 years of age 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 over 12 years of age with partial onset seizures that are refractory to antiepileptic medications.

Event Description
Reporter indicated that vns patient has experienced a recent increase in seizure frequency and a recent episode of status epilepticus. It was reported that the patient had been doing "great" with the vns therapy until recently. The patient's family has noticed that the patient is napping more, which is unusual for them. In addition, the patient's family member recently noticed the patient's face twitching, after which they experienced an episode of status epilepticus which reportedly lasted for approximately seven hours. Swiping the device with the magnet during the status episode did not help and no cough was elicited with magnet use as it had been in the past. The patient's family member believes that the generator may be nearing end of life and plans a follow-up visit with treating neurologist for device diagnostic testing. Review of manufacturing 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 the cause of the reported increase in seizure frequency and status episode.


http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=591466




Title: Re: Increase in seizures
Post by: dennis100 on December 01, 2011, 12:13:44 PM
Model Number 101
Event Date 04/01/2005
Event Type Injury Patient Outcome Life Threatening;
Event Description
Vns patient has been experiencing an increase in seizure activity, shortness of breath, increased respiration, increased heart rate, left ear pain and increased sallvation for a couple of months. It was also reported that the patient has been scheduled for an echocardiogram and holter monitor. Approximately 5 months ago, the patient fell on their back. X-rays were taken and reviewed. No abnormalities regarding the vns system were noted on the x-ray review. Device diagnostic testing was within normal limits, indication proper device function. It was further reported that there were medication changes in the patient's lamictal and depakote during this time. Investigation to day has been unable to determine whether the vns is a contributing factor to the increased heart rate or whether the increase in seizure activity was above pre-vns baseline frequency as no response has been received to manufacturer's request for additonal information from treating neurologist.

Manufacturer Narrative
H. 6: ncp system labeling lists dyspnea (difficulty breathing, shortness of breath), heart rate/rhythm changes and ear pain as potential adverse events possibly associated with surgery or stimulation.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=621159


Title: Re: Increase in seizures
Post by: dennis100 on December 01, 2011, 12:14:30 PM
Model Number 101
Event Date 06/01/2005
Event Type Injury Patient Outcome Life Threatening;
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 over 12 years of age 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 over 12 years of age with partial onset seizures that are refractory to antiepileptic medications.

Event Description
Reporter indicated that vns patient was hospitalized for monitoring due to an increase in seizure activity. It was reportedly unclear whether the increase was above pre-vns baseline frequency. There had reportedly not been any recent changes to the patient's drug regimen. 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. It was reported that the patients's family member does not believe that use of the magnet is as effective as it had been in the past. Proper technique of magnet mode activation was confirmed; however, after numerous attempts at initiating magnet mode stimulation, only 17 magnet activations were recorded in device programming history over the past 6 months time period. Treating physician attempted to initiate magnet mode stimulation and noted that the patient did not feel the device stimulate and the activation was not recorded in the device programming history. The patient was to remain in the hospital for eeg monitoring, pending receipt of a new magnet. Additional attempts to activate magnet mode stimulation will be made upon receipt of a replacement magnet. Review of manufacturing records for both the pulse generator and the bipolar lead revealed no anormalies that would adversely affect device performance.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=621610




Title: Re: Increase in seizures
Post by: dennis100 on December 01, 2011, 12:15:40 PM
Model Number 102
Event Date 02/25/2005
Event Type Injury Patient Outcome Life Threatening;
Event Description
Reporter indicated that patient's seizures have progressively worsened since generator replacement surgery to the point that they are experiencing daily seizures. The patient has sustained multiple injuries during seizures and was recently found lying in the street after a seizure. Treating neurologist indicated that the patient has experienced 15 grand mal seizures in the past two months in addition to the partial seizures that they experience several times per day. The patient reportedly continues to experience delirium, delusions and hallucinations and is doing poorly in regards to their seizure activity as well as their psychiatric condition. The patient has experienced several events of closed head trauma with scalp lacerations due to the seizures; however, recent cat scan of the head was negative. Device diagnostic testing at office visit was within normal limits, indicating proper device function. Neurologist reported that prior to generator replacement surgery, the patient was doing very well with the vns therapy and that there had been no real changes to their epilepsy treatment plan. Neurologist has recommended that the patient discontinue at least one of their medications to see if there is any improvement in seizure frequency.

Event Description
Further follow-up revealed depakote was added to the patient's medication regimine and that the device on time was decreased to 1. 1 minutes.

Manufacturer Narrative
H. 6. Treating neurologist indicated that he was concerned that the high closes of zyprexa along with ability might be the cause of the patient's increase in seizure activity.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=619797





Title: Re: Increase in seizures
Post by: dennis100 on December 01, 2011, 12:16:55 PM
Model Number 102
Event Date 03/31/2005
Event Type Injury Patient Outcome Life Threatening;
Event Description
Reporter indicated that vns patient has experienced an increase in seizure activity above pre-vns baseline frequency. Pre-vns seizure frequency is documented as being 2 generalized tonic-clonic seizures in the eight-month period before vns implant and 10-20 absence seizures per day. Since the increase in seizure activity, the patient is reportedly experiencing 3-4 generalized tonic-clonic seizures per week along with the absence seizures. The patient family member reports that only in an improvement in the patient's post-ictal state was initially noticeable post-implant. It was reported that the patient began to experience myoclonic and secondary generalized tonic-clonic seizures during progamming session at office visit and that since then, the patient has shown no improvement in seizure control with the vns therapy. Additionally, voice change with magnet swipes is no longer evident since that office visit. Device diagnosiic testing waswithin normal limits, indicating proper device function. Review of manufacturing records for both the pulse generator and the bipolar lead revealed no anomalies that would adversely affect device performance. The patient is scheduled to follow-up with a different physician.

Manufacturer Narrative
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.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=622308




Title: Re: Increase in seizures
Post by: dennis100 on December 01, 2011, 03:31:50 PM
Model Number 102
Event Date 05/10/2004
Event Type Injury Patient Outcome Required Intervention;
Event Description
Further follow-up revealed that the pt's seizures seemed to decrease after programming the device to off. It was reported that the pt began to lose consciousness with seizures prior to programming the device to off. Physician reportedly tried to resolve the increase in seizures by adjusting device settings prior to programming the device to off.

Manufacturer Narrative
Report is incomplete.

Event Description
Reporter indicated that the patient's seizures increased after being implanted with the vns system. The device was subsequently turned off.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=614711



Title: Re: Increase in seizures
Post by: dennis100 on December 01, 2011, 03:33:21 PM
Model Number 101
Event Type Malfunction
Event Description
Further follow-up revealed that the pt experienced bradycardia prior to having a vns implant. It was also reported that the pt is doing well since he had a new vns generator implanted. No further incidents of bradycardia have been reported to the mfr. It was not confirmed if the bradycardia was related to the vns therapy. The generator was returned and analyzed. Product analysis summary: the device current output was observed and monitored for 27. 0 hours at 38. 5 degrees c. No variations in output were noted. The magnet output responded appropriately, as programmed. There were no performance discrepancies observed. No electrical or visual anomalies were identified that could adversely affect device performance. The generator is operating within limits, meeting the mfr's final electrical test specifications. The cause of the reported stimulation could not be felt and increased seizures are unknown as the device was found to operating as intended in analysis. Potential causes of not feeling stimulation include: user error, device malfunction and pt has becoome accustomed to the device stimulation, therefore, no longer feels it. Potential causes of increased seizures include: without pt knowledge, the generator reaches end-of-service or is nearing end-of-service, generator malfunction, lead discontinuity, inadequate settings which resolved after parameter changes, user error, disease related (disease progression), change in drug regimen and/or interactions with anti-epileptic drugs, sleeping abnormalities, depression and anti-depressants, insufficient physician training.

Manufacturer Narrative
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 pt has experienced a recent increase in seizure activity above previous efficacy with the vns therapy. It was also reported that initiation of magnet mode stimulation no longer elicited a coughing response from the pt as it had in the past. Review of x-rays did not reveal any obvious discontinuities in the ncp system. Based on known device settings, generator battery end of life is not likely. Device diagnostic testing was within normal limits, indicating proper device function. Investigation has been unable to confirm proper device function as no response has been received to manufacturer's request for additional info from treating neurologist.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=663804



Title: Re: Increase in seizures
Post by: dennis100 on December 01, 2011, 03:34:37 PM
Model Number 100
Event Date 11/01/2003
Event Type Injury Patient Outcome Life Threatening; Other
Event Description
Product analysis was performed. Analysis confirmed that the pulse generator was at normal end of service (battery depletion). Using the available programming history for this pulse generator, the estimated battery life with 3. 25 years. The pulse generator was implanted for 5. 75 years, which exceeded the battery life. External visual inspection of the generator revealed no anomalies. The reported increased in seizures was likely due to the pulse generator's battery depletion.

Manufacturer Narrative
Review of manufacturing records for the pulse genrator revealed no anomalies that would adversely affect device performance. Investigation has been unable to determine whether the increase in seizure activity was an increase above pre-vhs baseline frequency and has been unable to confirm normal end of battery life as no reponse has been received to manufacturer's requests for additional information from treating neurologist. Additionally, the explanted generator has not been returned to manufacturer for analysis because the health professional in possession of the device does not believe that the manufacturer's product return kit is in compliance with iata guidelines for shipment of "dangerous goods. ".

Event Description
Reporter indicated that vns patient experienced an increase in seizure activity, presumably due to generator battery end of life. The patient was reportedly experiencing "major breakthrough seizures". Approximately one month later, the patient was seen in hospital emergency room where they received 25 stiches due to injury suffered during a fall, presumably a fall with seizure. The patient underwent generator replacement surgery approximately one month later.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=618079



Title: Re: Increase in seizures
Post by: dennis100 on December 01, 2011, 03:35:46 PM
Model Number 102
Event Date 04/01/2005
Event Type Injury Patient Outcome Life Threatening;
Manufacturer Narrative
H. 6. Vns therapy system labeling lists increased coughing as a potential adverse event possibly associated with surgery or stimulation.

Event Description
Vns pt was experiencing "a lot of seizures". It was reported that on one day, the pt experienced 5 generalized tonic-clonic seizures within two hours. According to the pt's family member, the pt has been missing a lot of school due to seizures. The pt has also experienced itching, behavioral issues, feeling like their skin is crawling and an increase in coughing. The pt reportedly attacked a neighbor, at which time their family member had to physically restrain them. There have reportedly been some medication changes since the onset of symptoms and it was reported that last blood levels (date unk) showed that the pt' medication levels were high. The pt has recently changed to a different neurologist and their family member believes that they are over-medicated. Investigation has been unable to determine whether the recent increase in seizures activity is above pre-vns baseline frequencyas no response has been received to mfr's requests for additional info from treating neurologist (via fax x1).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=616505



Title: Re: Increase in seizures
Post by: dennis100 on December 01, 2011, 03:36:36 PM
Model Number 102
Event Date 05/12/2005
Event Type Injury Patient Outcome Life Threatening; Hospitalization Required Intervention
Event Description
Vns patient has recently experienced an increase in seizure activity above pre-vns baseline frequency. It was reported that the patient has been experiencing left jaw pain and that the recently experienced a prolonged seizure requiring use of diastat. The patient was seen in hospital emergency room when their seizure frequency tripled, at which time they experienced labored breathing after a grand mal seizure. The patient's device was programmed to off the following day. The patient has not experienced any recent injury or trauma that may have damaged the vns therapy system and review of x-rays did not reveal any obvious discontinuities in the system. The patient is scheduled for follow-up with treating neurologist who plans to perform device diagnostic testing.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=615389



Title: Re: Increase in seizures
Post by: dennis100 on December 01, 2011, 03:37:42 PM
Model Number 101
Event Date 01/01/2005
Event Type Injury Patient Outcome Life Threatening;
Event Description
Vns pt was experiencing an increase in seizure activity. With the vns therapy, the pt previously experienced approximately 2 seizures per day. Seizure frequency has recently increased to as many as 20 seizures per day with the vns therapy. Investigation has been unable to determine whether the increase in seizure activity is above pre-vns baseline frequency because the treating physician recently inherited the pt from another physician. Device diagnostic testing revealed that the elective replacement indicator was no, indicating that the generator battery had not reached end of life. There had been no medication or device parameter adjustments during the six month period that the new physician had seening the pt.

Manufacturer Narrative
Due to an administrative error, the suspect medical device (pulse generator) implant date was incorrect.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=618542



Title: Re: Increase in seizures
Post by: dennis100 on December 01, 2011, 03:38:58 PM
Model Number 101
Event Date 05/01/2005
Event Type Injury Patient Outcome Hospitalization; Required Intervention
Event Description
Further follow-up revealed that the pt underwent vns therapy system replacement. Both the pulse generator and bipolar lead were replaced. It was reported that the septum plug "popped" out of the generator; therefore, the generator was replaced.

Event Description
Vns patient was experiencing an increase in seizure activity. The patient complained that their device was not working and that use of the magnet was not working to abort their seizures. Medication levels are reportedly within normal limits. The patient continues to experience daily tonic-clonic ceizures for 15-20 minutes duration. The patient also reports some memory loss. The patient indicated that their physicians "will not help" and that they would like to have the devices replaced. Fruther follow-up revealed that the patient was hospitalized for seizures monitoring. Device diagnostic testing while hospitalized was within normal limits, indicating proper device function. Changes to drug regimen were implemented upon discharge from hospital. Investigation has been unable to determine whether the patient has experienced an increase in seizure activity above pre-vns baseline frequency. Treating physician cited hipaa regulation as reason for not releasing information about the event to device manufacturer. Based on known device settings, generator battery end of life is not suspected. Review of manufacturing records for the pulse generator refvealed no anomalies that would adversley affect device performance.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=618883



Title: Re: Increase in seizures
Post by: dennis100 on December 01, 2011, 03:39:58 PM
Model Number 300-20
Event Type Injury
Event Description
Reporter indicated that device diagnostic testing resulted in high lead impedance reading, indicating possible device malfunction. The patient was hospitalized for poor seizure control at the time of the initial report. Treating neurologist indicated that the patient was not experiencing an increases in seizure activity above pre-vns baseline. The patient reportedly falls a lot and has always had poor seizure control, but neurologiest indicated that the patient's seizures began to worsen approximately 9 months prior. Neurologist indicated that he has been adjusting the patient's medications in an effort to gain seizure control but that he has not made any changes to programed device parameters. Based on known device settings, generator battery end of life is not likely. Lead break is suspected and revision surgery is likely. 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 no response has been received to manufacturer's request for additional information from treating neurologist (via fax x1).

Event Description
Further follow-up revealed that revision surgery is not being considered at this time. Neurologist indicated that no further information would be released regarding the pt. The cause of the suspected lead break is likely due to trauma as it was reported that the pt frequently falls.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=612725



Title: Re: Increase in seizures
Post by: dennis100 on December 01, 2011, 03:40:29 PM
Model Number 101
Event Date 05/06/2005
Event Type Malfunction
Event Description
Reporter indicated that vns pt was unable to feel device stimulation the day after normal mode output current was programmed to 1. 75ma and that the pt also experienced an increase in seizure activity on the day that pt could not feel device stimulation. Treating neurologist does not know whether the increase in seizure activity was above pre-vns baseline frequency. At follow-up office visit a few days later, the pt's device was interrogated, after which the pt felt device stimulation. Based on known device settings, generator battery end of life is not likely. Review of manufacturing records for the pulse generator revealed no anomalies that would adversely affect device performance. Investigation has been unable to determine whether the device is functioning properly because requested device programming history has not been received for review. Report is incomplete because no response has been received to manufacturer's request for additional information from treating neurologist (via fed-ex x1, via telephone x1).

Event Description
Further follow-up revealed that the physicain believes the increase in seizure was likely caused by a decrease in the pt's anti-epileptic medications or stress due to the pt's pregnancy. Programming history was received and reviewed. There were no anomalies or programming errors seen on teh programming history that would cause or contribute to the pt not feeling stimulation. The pt is currently doing fine and can feel device stimulation. The pt may be becoming accustomed to the stimulation; therefore, not feeling as previously reported.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=634829




Title: Re: Increase in seizures
Post by: dennis100 on December 02, 2011, 06:02:04 AM
Model Number 300-20
Event Date 01/01/2005
Event Type Malfunction
Event Description
Reporter indicated that pt's device diagnostic testing at office visit resulted in high impedance reading (dc dc code 7, limit), indicating possible device malfunction. Pt also experienced an increase in seizures believed to be due to the high impedance. No serious injury reported due to the increase in seizures. X-rays were performed and treating neurological facility indicated that no anomalies were noted, however, the device was not very visible via x-rays. Pt underwent revision surgery. Both lead and generator was replaced. Further follow up revealed that the device has been programmed back to on recently but it is too early to tell if the pt's seizure control has improved. Review of manufacturing records for both the ncp pulse generator and the bipolar lead revealed no anomalies that would adversely effect device performance.

Event Description
Lead assembly was returned in pieces, excluding a portion of the electrodes. During visual analysis , a lead coil break was identified near the connector bifurcation. A second coil break was identified on one of the coils of the reutrned portion near the anchor tether. The lead coils were further analyzed using electron microscopy. Electron microscopy verified one end of the coil break near the connector bifurcation was mechanically damaged with pitting and and the other end was mechanically damaged, rubbed smooth to a point with fine pitting; therefore the fracture mechanisms could not be determined. It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting on the broken coil wires. However, in all cases a conclusive determination cannot be made whether the stimulation was flowing at the exact time of fracture. The condition of the lead portion returned is consistent with the conditions that typically exist following an explant procedure. No other obvious anomalies were noted. The setscrew marks found on the lead connector pin showed evidence that, at one point in time, proper mechanical and electrical connection was present. Using a multimeter, continuity checks of the various lead sections were performed with no other discontinuities identified. Based on the product analysis findings, there is evidence to suggest the identified lead discontinuities would have contributed to the stated complaint of high impedance during a normal mode or system diagnostic test. The concomitant device (pulse generator) was also returned and analyzed. The pulse generator met electrical test specifications. The pulse generator did not show any condition that would have contributed to the reported event. The exact cause of the lead breaks are unknown: possible causes of lead discontinuity are: mechanical failure, implant technique (use of suture, no strain relief), "twiddler" (twisting of the lead) violent seizure, physical injury/accident.

Event Description
Further foll0w up revealed that the patient's seizures have decreased and are shorter in duration since ncp system replacement. Neurologist indicated that there were no environmental stimuli or any changes in medications that could have contributed to the increase in seizures.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=644153



Title: Re: Increase in seizures
Post by: dennis100 on December 02, 2011, 06:02:35 AM
Model Number 102
Event Date 07/22/2005
Event Type Injury Patient Outcome Life Threatening;
Event Description
Reporter indicated that vns patient had been experiencing an increase in seizure activity since their last appointment, at which time an adjustment was made to the device settings. It was reported that the patient's seizure frequency has increased from 0 or 1 seizure per month to approximately 10 seizures per month, and that this increase was above the patient's pre-vns baseline frequency. The patient's family member report reports that the patient was doing extremely well with the vns therapy before the adjustment to programmed parameters and that there had been no recent changes to the patient's medication regimen. The patient is scheduled to follow-up with treating neurologist to re-evaluate device settings. Report is incomplete because no response has been received to manufacturer's requests for additional information from treating neurologist.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=635585


Title: Re: Increase in seizures
Post by: dennis100 on December 02, 2011, 06:03:17 AM
Model Number 101
Event Date 01/01/2005
Event Type Injury Patient Outcome Life Threatening;
Event Description
Reporter indicated that vns pt has experienced a increase in seizure activity above pre-vns baseline frequency. Report is incomplete because last know neurologist has reportedly discharged the pt from their care and has not seen the pt recently. The pt's family is reportedly experiencing difficulty in obtaining a new neurologist that will accept their insurance carrier. The pt's family member was able to make an appointment with a doctor to see the pt in three months time and that in the meantime, family member may discontinue the pt's depakote because family member feels as though the pt's seizure are worse on this medication. The pt's family member believes that the generator battery may have reached end of life because the pt's device is set to the highest setting of output current.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=635195


Title: Re: Increase in seizures
Post by: dennis100 on December 02, 2011, 06:04:14 AM
Model Number 102
Event Date 07/15/2005
Event Type Injury Patient Outcome Life Threatening; Required Intervention
Event Description
Further follow-up with treating neurologist indicates that the patient's condition is currently "good" and that she has not experienced a grand mal seizure for thirty days. Device settings were adjusted and device diagnostic testing was reportedly within normal limits, indicating proper device function. The electivwe replacement indicator wasno, ruling out generator battery end of life as a possible cause of the reported event. Neurologist indicated that prior to improvement in her condition, the patient's increase in seizure activity was above pre-vns baseline frequency. It was reported that the patient's overall health condition was not worsening and that there were no environmental stimuli that may have contributed to the reported increase in seizure activity.

Event Description
Reporter indicated that vns pt has experienced one generalized tonic-clonic seizure at exactly 9:25pm every ten days since implant. It was reported that the pt had not experienced this type of seizure for approximately 18 months prior to vns implant. There have reportedly been no recent changes to the pt's medication regimen. Report is incomplete because device tracking information was not received by mfr after implant. Additionally, no response has been received to mfr's request for additional info from treating neurologist.

Manufacturer Narrative
Due to an administrative error, the suspect medical device (pulse generator) implant date was incorrect.

Manufacturer Narrative
Treating neurologist indicated that the reported event was not believed to be related to the vns therapy, but was possibly due to disease process.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=634847



Title: Re: Increase in seizures
Post by: dennis100 on December 02, 2011, 06:04:55 AM
Model Number 102
Event Date 08/10/2005
Event Type Injury
Event Description
Reporter indicated that vns pt recently experienced an increase in seizure activity (40 seizures in one day). With the vns therapy, the pt's seizure frequency had reportedly been reduced to 30 seizures per month. Treating neurologist had reportedly decreased device settings approximately three weeks earlier because the pt couldn't stop coughing. The pt had not experienced any recent injury or trauma that may have damaged the vns therapy system. It was reported that the pt may not have taken their antiepileptic medications on the day that the increased seizures activity was experienced. Investigation to date has been unable to determine whether the increase in seizure activity is above pre-vns baseline frequency. Pre-vns seizure frequency is unknown, although it was reported that the pt "had multiple seizures" prior to vns implant. Review of manufacturing records for both the pulse generator and the bipolar lead revealed no anomalies that would adversely affect device performance.

Manufacturer Narrative
Vns therapy system labeling states that the safety and efficacy of this therapy have not been systematically established for use in patients with history of previous therapeutic brain surgery.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=634113



Title: Re: Increase in seizures
Post by: dennis100 on December 02, 2011, 06:05:29 AM
Event Date 08/01/2005
Event Type Injury Patient Outcome Life Threatening;
Event Description
Reporter indicated that vns pt was experiencing an increase in seizure activity. Investigation to date has been unable to determine whether the increase in seizure activity is an increase above pre-vns baseline frequency.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=634140



Title: Re: Increase in seizures
Post by: dennis100 on December 02, 2011, 06:05:58 AM
Model Number 102
Event Date 01/01/2005
Event Type Injury Patient Outcome Life Threatening;
Event Description
Reporter indicated that vns patient was experiencing an increase in tonic-clonic seizures. The patient had reportedly been doing well with the vns therapy until a recent increase in stimulation received (decrease of off time from 5 minutes to 2 minutes). Approximately three days after device off time was decreased the patient's tonic-clonic seizure frequency increased from 1 seizure every two days to 5 seizures per day.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=633150



Title: Re: Increase in seizures
Post by: dennis100 on December 02, 2011, 06:06:36 AM
Model Number 101
Event Date 08/02/2005
Event Type Injury Patient Outcome Required Intervention;
Event Description
Reporter indicated that vns patient had a seizure, which was not normal for them with the vns therapy. The patient reported that they had undergone laser eye surgery the same day that they experienced the seizure. It was later reported that the patient experienced three more seizures that evening. Device diagnostic testing was within normal limits, indicating proper device function. Treating neurologist indicated that vns patient had experienced three breakthrough seizures during the week before patient underwent the laser eye surgery. Dilantin dosage was increased and tegretol was added to the patient's drug regimen. The patient was instructed to follow-up in two months and keep a strict seizure log to evaluate their true seizure frequency. Investigation to date has been unable to determine whether the increase in seizure activity was an increase above pre-vns baseline frequency.

Event Description
Further follow-up revealed that device diagnostic testing showed the elective replacement indicator to be no, indicating that the generator battery had not reached end of life. Review of dr's notes from clinic visits revealed that the pt has complained of seizure frequency being 3 times per week since approximately two months prior to undergoing laser eye surgery. It was reported that the pt's bed partner tells her that she had a seizure during sleep. Attempts to increase device pulse width setting at recent office visit were not tolerated by the pt. The pulse width setting was ultimately not increased because the pt reported that her throat felt tight afterward. The pt's condition was reported to be "stable" at each of three office visits o ver five month's time, including the time period during which the pt initially reported to mfr that she had experienced a seizure, which was not normal for her.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=632337



Title: Re: Increase in seizures
Post by: dennis100 on December 02, 2011, 06:07:10 AM
Model Number 300-20
Event Type Malfunction
Event Description
Reporter indicated that device diagnostic testing at office visit resulted in high lead impedance reading (dc-dc code 7 and limit), indicating possible device malfunction. The elective replacement indicator was no, indicating that the generator battery had not reached end of life. It was also reported that the pt was experiencing an increase in seizure activity. Both pre-vns and with the vns therapy, the pt experienced approx two seizures per day and is now experiencing between 4-5 seizures per day. The pt has reportedly never seemed to receive great benefit from the vns therapy, but at an earlier date when they turned off vns to measure its benefit, the pt worsened so it was determined that vns therapy was helpful for this pt. Treating neurologist believes that the recent increase in seizure activity is related to a loss of vns therapy. Lead break is suspected. Revision surgery is likely. The pt has not suffered any recent injury or trauma that may have damaged the vns therapy system. Review of manufacturing records for the bipolar lead revealed no anomalies that would adversely affect device performance.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=663943


Title: Re: Increase in seizures
Post by: dennis100 on December 02, 2011, 06:07:47 AM
Model Number 102
Event Date 03/01/2005
Event Type Injury Patient Outcome Life Threatening;
Event Description
Reporter indicated that vns patient has experienced an increase in seizure activity above pre-vns baseline frequency over the past four months. The patient was recently seen in hospital emergency room during one of their seizure episodes. The patient in non-verbal and cannot communicate whether or not they can feel device stimulation. Treating neurologist plans to perform device diagnostic testing at next office visit. Neurologist indicated that there were "so many things that could be causing the increase in seizures" and that they were in the process of trying to rule out possible causes. Neurologist indicated that they did not know whether the vns therapy could be contributing to the event

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=629298


Title: Re: Increase in seizures
Post by: dennis100 on December 02, 2011, 06:08:28 AM
Model Number 102
Event Date 06/03/2005
Event Type Injury Patient Outcome Required Intervention;
Event Description
Reporter indicated that vns patient's seizure activity increased above pre-vns baseline frequency after stimulation was initiated approximately two weeks post-implant. The patient's family member reported that family member used to be able to hold the patient in their arms, preventing pt from falling when pt had a seizure, but that with the vns therapy family member was no longer able to do this and the patient has subsequently fallen to the ground. Normal mode stimulation was programmed to off approximately six weeks after stimulation was initiated, with magnet mode stimulation programmed to off one week later. The patient's family member reported that prior to programming the device to off, the device settings were "as high as they could go" and reported that the patient only felt device stimulation on four occasions. The patient's family member reported that treating neurologist did not plan any other intervention at this time. Treating neurologist indicated that the patient had seizures "all of the time" before vns implant and that it is not believed that the patient's seizure activity has increased above pre-vns baseline frequency. Device diagnostic testing was within normal limits, indicating proper device function. Review of manufacturing records for the pulse generator revealed no anomalies that would adversely affect device performance.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=628418



Title: Re: Increase in seizures
Post by: dennis100 on December 02, 2011, 06:09:05 AM
Model Number 102
Event Date 12/18/2003
Event Type Injury Patient Outcome Life Threatening;
Event Description
Reporter indicated that vns patient has experienced drop attack seizures since implant. The patient usually experiences complex partial seizures and at time genarilized seizures, but the patient has been having more drop attacks since vns implant. Treatng neurologist programmed the patient's deivces to off and plans to monitor the patient over the following two months to see if the vns therapy could possibly be related to this change in seizure pattern.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=627051


Title: Re: Increase in seizures
Post by: dennis100 on December 02, 2011, 06:09:48 AM
Model Number 102
Event Date 06/18/2005
Event Type Injury Patient Outcome Life Threatening;
Event Description
Reporter indicated that patient went into status. Further follow up revealed that patient came into neurology clinic having brief partial complex seizures with continued dopiness between events. Nine days prior, patient had device output currents increased from 1. 0ma to 1. 5ma for normal mode stimulation and 1. 25ma to 1. 5ma for magnet mode stimulation. It was at this time that the patient started to have an increase in seizures. The increase was above pre vns seizure baseline. Prior to vns therapy, the patient started to have an increase in seizures. The increase was above pre-vns seizure baseline. Prior to vns therapy, the patient had an average of 5 seizures a month and the neurologist's nurse reported that she is not aware of the patient over having a status epilepticus episode before this event. In addition, the patient had improved seizure control and was able to abort seizures using the magnet. At subsequent clinic visit, the patient's parameters were programmed back to previous settings. Treating neurologist's nurse does not know about the patient's current condition; however, the nurse indicated that if the neurologist's office does not hear anything from the patient's family members, everything is fine.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=625541



Title: Re: Increase in seizures
Post by: dennis100 on December 02, 2011, 06:10:28 AM
Model Number 102
Event Date 11/15/2004
Event Type Injury Patient Outcome Life Threatening;
Event Description
Reporter indicated that pt's seizures have worsened since being implanted. There had reportedly been no changes to the pt's drug regimen. Treating neurologist plans to perform device diagnostic testing to confirm proper device placement on the vagus nerve. Report is incomplete because no response has been received to manufacturer's requests for additional information from treating neurologist.

Event Description
Further follow-up revealed that neurologist does notbelieve that the vns therapy system is related to the pt's increase in seizures, and that a decreased dose of the felbatol is a possible cause. Neurologist reported that the pt's parents indicated tht the pt's myoclonic jerks are better, however, that the pt has experienced more generalized tonic clonic seizures. Device diagnostic testing was within normal limits, indicating proper device function.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=625382



Title: Re: Increase in seizures
Post by: dennis100 on December 02, 2011, 06:11:15 AM
Model Number 101
Event Date 01/01/2005
Event Type Injury Patient Outcome Life Threatening;
Manufacturer Narrative
Rpt is incomplete because the pt is not currently seeing a neurologist that the mfr can contact.

Event Description
The rptr indicated that the pt has been experiencing an increase in seizure activity over the last several mos. The rptr also stated that the pt's medication levels were checked and found to be normal. It was reported that the pt has not had their vns system checked in "a very long time. " the rptr did not know if the increase in seizures were above the pt's pre-vns baseline frequency. At this time there is no evidence that the vns caused or contributed to the event. The pt is no longer going to their previous neurologist; pt is currently looking for a new one. This event is currently being investigated.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=623898



Title: Re: Increase in seizures
Post by: dennis100 on December 02, 2011, 06:11:48 AM
Model Number 102
Event Date 01/01/2005
Event Type Injury Patient Outcome Life Threatening;
Event Description
Reporter indicated that vns pt is experiencing different kinds of seizures than before pt was implanted with the vns therapy system. It was reported that the pt now experiences headaches and grabs their head before each seizures. The pt's family member reports that the vns therapy has helped to control the pt's little seizures, but that now the pt is experiencing harder, different seizures. The pt plans to follow-up with their neurologist for evaluation. Report is incomplete because no response has been received to manufacturer's requests for additional information from treating neurologist.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=635132



Title: Re: Increase in seizures
Post by: dennis100 on December 02, 2011, 06:14:53 AM
Model Number 102
Event Date 07/01/2005
Event Type Malfunction
Event Description
Reporter indicated that patient can no longer feel normal and magnet mode stimulation. Reporter also indicated that the patient has had an increase in seizure activity for the past 12 days. The patient has had previous good seizure control with vns therapy and then a sudden uncontrollable increase in seizures. The patient was admitted to the hospital and reportedly discharged with having seizures. The patient has not suffered from any trauma and the reporter was not aware of any medication or device parameters changes prior to events. Further follow up with treating neurologist office indicated that the patient has pseudoseizures as confirmed by an eeg. The patient was also sent to another hospital for a second opinion because the original hospital refused to see them again. The second hospital also diagnosed the patient with pseudoseizures. The patient reportedly has a psychological component associated with their complaints. The neurologist office staff are not to talk the patient and/or family members because of these issues. The neurologist feels none of these issues are related to vns therapy but will do diagnostic testing when the patient returns for follow up. Patient has not seen the treating neurologist for diagnostic testing to determine device functionality. Investigation to date cannot determine if the reason that the patient cannot feel stimulation is due to patient accustomed to stimulation, generator end of life, or malfunction. Review of manufacturing records for the pulse generator revealed no anomalies that would adversely effect device performance.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=627609

Video EEG Monitoring should be an absolute must before any type of epilepsy surgery. Patients are misdiagnosed with epilepsy 30 to 40 percent of the time. That happens to be the success rate of the VNS. Does the FDA understand "Placebo Effect" ?




Title: Re: Increase in seizures
Post by: dennis100 on December 05, 2011, 11:10:31 AM
Model


Title: Re: Increase in seizures
Post by: dennis100 on December 05, 2011, 11:12:16 AM
l NumModeber 300-20
Event Type Malfunction
Event Description
Replacement surgery due to lead discontinuity. Both the lead and generator were replaced. Treating neurologist indicated that prior to replacement surgery, the patient reported an increase in seizure activity and not feeling device stimulation anymore. Device diagnostic testing at office visit resulted in high lead impedance reading (dc-dc code 7 and limit), indicating possible device malfunction. The elective replacement indicator was no, ruling out generator battery end of life as a likely cause of the high lead impedance test result. A high impedance test result was also obtained at previous office visit approximately six months prior, but physician chose to only monitor the patient at that time, because the patient had not experienced an increase in seizure activity. X-rays reviewed by treating physician did not reveal any obvious discontinuities in the ncp system. At the time of replacement surgery, the lead reportedly appeared to be intact, but had come loose from the nerve and was in soft tissue. The explanted products were returned to maufacturer for analysis. Approx 43. 5 cm of the lead assembly was returned for analysis in four pieces. Visual inspection revealed a break in both the positive and negative coils at the electrode bifurcation. It is believed that stimulation was present for some period of time after the fracture occurred as evidenced by the presence of pitting on the broken coil wire surfaces. Due to metal dissolution and mechanical distortion (smoothed surfaces), the fracture mechanism cannot be determined. Analysis of the concomitant device (pulse generator) revealed no anomalies that would adversely affect device performance. The pulse generator met visual and electrical specifications.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=648971



Title: Re: Increase in seizures
Post by: dennis100 on December 05, 2011, 11:13:03 AM
Model Number 102
Event Date 02/17/2005
Event Type Injury Patient Outcome Life Threatening; Required Intervention
Event Description
Reporter indicated that pt was explanted, due to an increase in seizure activity with the vns therapy, presumably above pre-vns baseline frequency. Report is incomplete, because no response has been received to mfr's requests for additional info from treating neurologist (via fax x1).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=648331


Title: Re: Increase in seizures
Post by: dennis100 on December 05, 2011, 11:13:45 AM
Model Number 101
Event Type Malfunction
Event Description
Device interrogation at office visit resulted in elective replacement indicator. Yes, indicating that the generator battery had reached end of life. Based on known device settings, the generator battery should have lasted approximately six more years prior to reaching end of life. It was also reported that the patient had experienced a decrese in efficiency. The patient underwent generator replacement surgery, due to suspected device malfunction. It was reported that device diagnostic testing just prior to generator replacement surgery was within normal limits, indicating proper device function. Investigation to date has been unable to confirm whether the device prematurely reached end of life as no reponse has been received to manufacturer's requests for device programming history from treating neurologist.

Event Description
The explanted pulse generator was returned to mfr for analysis. Product analysis summary: based on known device settings, the pulse generator battery should have lasted approx 1. 01 years longer before the elective replacement indicator would be triggered to yes; however, eri (elective replacement indicator) flag was observed prior to explant and confirmed during mfr's analyis of the returned product. Although the prediction results indicate 1. 01 add'l years until eri-yes, the eri flag is within allowable limits for battery longevity. The implant time of 3. 37 years (6/25/02-11/08/05) plus 1. 01 years estimated until eri [3. 37+1. 01=4. 38 years (total esimated life) -25%=3. 285 years (minimum estimated battery life)]. The battery exceeded the minimum allowable life by 0. 085 years. The reported generator battery end of life was not confirmed. The generator is borderline eri. After the "open can" process, the battery voltage measured 2. 61 volts, dipping to 2. 44v when a current draining process (such as an interrogation) was applied. As designed, the generator is considered eri (consider replacement) when the battery voltage drops to 2. 60v and eol (end of life) when the battery voltage drops to 2. 20v (depleted). Confirming that the generator reached normal eri (elective replacement indicator) is not possible at this time as the diagnostic data (dcdc codes) throughout the implant life of the device is not available.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=648765



Title: Re: Increase in seizures
Post by: dennis100 on December 05, 2011, 11:14:51 AM
Event Date 10/01/2005
Event Type Injury
Patient Outcome Life Threatening;
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 patient has experienced a recent increase in seizure activity, but that it was unknown whether it was an increase above pre-vns baseline frequency. Device diagnostic testing was within normal limits, indicating proper device function. The elective replacement indicator was no, ruling out generator battery end of life as a likely cause of the reported increase in seizure activity. Report is incomplete because no response has been received to manufacturer's requests for additional information from treating neurologist (via fax x2). Additionally, device tracking information was not forwarded to manufacturer at the time of implant and attempts to obtain it have been unsuccessful to date

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=650824



Title: Re: Increase in seizures
Post by: dennis100 on December 05, 2011, 11:15:35 AM
Model Number 102R
Event Date 10/31/2005
Event Type Injury
Event Description
Reporter indicated that vns patient has experienced an increase in seizure activity/severity above pre-vns baseline. The patient reported experiencing three "back to back" seizures which caused her to bite half of her tongue. The patient indicated that she has tonic-clonic seizures and that this episode of seizures was worse than pre-vns baseline. The patient reports that there have been no recent medications changes and that she has does not feel device stimulation and that use of the magnet will typically stop her seizures or reduce the intesity; however, she was alone during the seizures episode and the magnet was not used during the reported event. The patient plans to follow up with her treating neurologist to confirm proper device function. Report is incomplete because no response has been received to manufacturer's request for additional information from treating neurologist (via fax x2).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=649186



Title: Re: Increase in seizures
Post by: dennis100 on December 05, 2011, 11:16:17 AM
Model Number 102
Event Type Injury Patient Outcome Life Threatening;
Event Description
Reporter indicated that vns pt has experienced a recent increase in seizure activity. The pt has not experienced any recent injury or trauma that may have damaged the vns therapy system; however, it was reported that the pt's device "did not appear to be sitting correctly" and that it has been that way since implant. It was reported that the pt's generator is perpendicular in her chest. The pt reports feeling painful stimulation at the generator site along with feelings of muscle twitching during stimulation cycles for approximately three months. Investigation to date has been unable to determine whether the increase in seizure activity is above pre-vns baseline frequency as treating neurologist cited hipaa regulations as reason for not providing additional info.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=648036



Title: Re: Increase in seizures
Post by: dennis100 on December 05, 2011, 11:16:56 AM
Model Number 102
Event Date 01/01/2005
Event Type Injury Patient Outcome Life Threatening; Required Intervention
Event Description
Reporter indicated that vns pt has experienced an increase in seizure activity following a recent fall. Device diagnostic testing was within normal limits, indicating proper device function. Review of x-rays by treating neurologist did not reveal any obvious discontinuities in the vns therapy system. Device settings were adjusted. Investigation to date has been unable to determine whether the increase in seizure activity is above pre-vns baseline frequency.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=647875


Title: Re: Increase in seizures
Post by: dennis100 on December 05, 2011, 11:17:41 AM
Model Number 102
Event Date 03/22/2005
Event Type Injury Patient Outcome Life Threatening;
Manufacturer Narrative
The vns therapy system is indicated for use as an adjuctive 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 the pt's family member believes that the pt has experienced more seizures with the vns therapy. Report is incomplete because no response has been received to manufacturer's requests for additional information from treating neurologist.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=647889



Title: Re: Increase in seizures
Post by: dennis100 on December 05, 2011, 11:18:35 AM
Model Number 102
Event Date 01/01/2005
Event Type Injury Patient Outcome Life Threatening;
Manufacturer Narrative
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 adults and adolescents with partial onset seizures that are refractory to antiepileptic medications.

Event Description
Reporter indicated that vns pt was experiencing an increase in seizure activity. Device diagnostic testing was within normal limits, indicating proper device function. Investigation to date has been unable to determine whether the increase is above pre-vns baseline frequency as no response has been received to mfr's requests for additional info from treating neurologist.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=647913



Title: Re: Increase in seizures
Post by: dennis100 on December 05, 2011, 11:19:12 AM
Model Number 300-20
Event Type Malfunction
Event Description
Device diagnostic testing at office visit resulted in high lead impedance reading (dc-dc code 7 and limit), indicating possible device malfunction. The elective replacement indicator was no, ruling out generator battery end of life as a likely cause of the high lead impedance test result. The pt has experienced an increase in seizure activity; however, the treating neurologist has recently inherited the pt from another dr and therefore does not have much medical history. The pt reportedly experiences falls with his seizures. Lead break is suspected and revision surgery is likely. The pt has been referred for surgical consult.

Event Description
Review of x-rays did not reveal any obvious discontinuities in the ncp system. The pt underwent revision surgery, during which both the lead and generator were replaced. Intraoperative device diagnostic testing of the replacement system was within normal limits, indication proper device function. Device tracking info forwarded to mfr upon vns therapy system replacement indicates that the pt was explanted due to lead discontinuity. The pt is reportedly in good condition following vns therapy system replacement surgery, but continues to experience seizures because his replacement system has not yet been programmed to on.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=662963


Title: Re: Increase in seizures
Post by: dennis100 on December 05, 2011, 11:19:49 AM
Model Number 102
Event Date 10/01/2005
Event Type Injury Patient Outcome Life Threatening;
Event Description
The reporter indicated that the pt has been experiencing an increase in seizures. It is unk if the increase is above the pt's pre-vns baseline seizure frequency. It was reported that the pt's condition is stable, but he is on more anticonvulsants due to more seizures. The pt cannot tolerate vns stimulation due to hoarse voice and shocking sensations, therefore, the device was deactivated. X-rays were taken and the leads appeared to be properly placed. A lead test was run one month ago and resulted in ok lead impedance, indicating the device was properly delivering stimulation. Pt's surgeon recommended device removal. The cause of the reported events are unk at this time.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=647686


Title: Re: Increase in seizures
Post by: dennis100 on December 05, 2011, 11:20:41 AM
Model Number 300-20
Event Type Malfunction
Event Description
Further follow-up revealed that the reported high impedance did resolve after the revision surgery to re-connect the generator to the lead. The reported seizure increase has gotten better. The medical professional indicated that it is believed that the increase in seizure was related to the vns not delivering therapy.

Manufacturer Narrative
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. It is likely that the pt's fall was the cause of the generator/lead connection problem.

Event Description
Vns pt revision surgery due to suspected lead break. The pt reportedly experienced a recent fall, during which she broke her arm. The pt has experienced an increase in seizures activity since the fall and subsequent device diagnostic testing reportedly resulted in high lead impedance reading, indicating possible device malfunction. During the revision surgery, it was noted that the positive lead connector pin was not properly connected to the pulse generator. The lead connector pin was then properly connected, after which device diagnostic testing was within normal limits, indicating proper device function.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=662981



Title: Re: Increase in seizures
Post by: dennis100 on December 05, 2011, 11:21:19 AM
Model Number 101
Event Date 01/01/2005
Event Type Injury Patient Outcome Life Threatening;
Event Description
Reporter indicated that vns pt has experienced an increase in seizure activity above pre-vns baseline frequency. It was also reported that the pt's seizure type had changed in that she has begun to experience grand mal seizures recently. There have reportedly been no medication changes that may have contributed to the reported events, but that she had recently been crushed by elevator doors. The pt reported that she has never experienced efficacy with the vns therapy. The pt also reports that she has experienced chest pain and pain shooting down her neck and back, shooting through her stomach and down her legs as well as muscle spasms in her leg. The pt was reportedly seen at a local hospital recently, at which time "the doctors there dismissed her as having the flu", although the pt maintains that she did not have the flu. Investigation to date has been unable to determine whether the pt's chest pain is cardiac related or whether it is related to the vns therapy as attempts to identify the pt's current treating physician have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=647201


Title: Re: Increase in seizures
Post by: dennis100 on December 05, 2011, 11:21:57 AM
Event Type Malfunction
Patient Outcome Life Threatening;
Event Description
Further follow-up with the treating physician revealed that with device programming changes, the patient's seizure are now under control. The reported seizure increase was likely due to the patient not receiving the vns therapy due to the lead issue. Attempts to retrieve the devices for analysis have been unsuccessful to date.

Manufacturer Narrative
The vns therapy system is indicated for use as an adjunctive therapy in reducing the frequency of seizures in adults and adolscents 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 adolscents with partial onset seizures that are refractory to antiepileptic medications. Treating neurologist believes that the increse in seizure activity is related to the vns therapy.

Event Description
Reporter indicated that vns patient was scheduled for revision surgery because it had been determined that the patient's lead had "become loose". Further follow-up revealed that the patient underwent vns therapy system replacement surgery, at which time both the lead (excluding electrodes) and generator were replaced. X-rays were taken prior to surgery and reportedly did not reveal any obvious evidence of discontinuity in the vns therapy system; however, device diagnostic testing prior to vns therapy system replacement surgery resulted in high lead impedance reading (dc-dc-code 7 and limit), indicating possible device malfunction. The patient had not experienced any recent injury or trauma that may have damaged the vns therapy system, but had experienced a recent increase in seizure activity (both in frequency and severity) medication changes reportedly could have played a part in the increase in seizure activity. Approximately three months before the increase in seizure activity, the patient was weaned off of keppra. Topamax was increased when seizure activity increased, and the patient was weaned off of depakote. The patient's seizure frequency increased above pre-vns baseline frequency following vns therapy system replacement surgery. The cause of the high lead impedance reading is unknown. Fibrosis between the lead electrodes and the vagus nerve is suspected, as it was reported that the anchor tether of the replacement lead was not placed on the nerve due ot lack of room from previous scarring and the presence of the old lead coils still attached to the nerve.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=647203



Title: Re: Increase in seizures
Post by: dennis100 on December 05, 2011, 11:22:33 AM
Model Number 300-20
Event Type Malfunction
Event Description
Reporter indicated that pt underwent vns therapy system replacement surgery due to the lead discontinuity and subsequent increase in seizure activity. There was reportedly no pt trauma or manipulation of the device. X-rays reviewed by physician did not reveal any obvious discontinuities in the vns therapy system. Device diagnostic testing prior to vns therapy system replacement surgery yielded high lead impedance test result (specifics unk), indicating possible device malfunction. The increase in seizures activity resolved following vns therapy system replacement. The cause of the suspected lead break is unk.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=662899


Title: Re: Increase in seizures
Post by: dennis100 on December 05, 2011, 11:23:10 AM
Model Number 102
Event Date 06/01/2005
Event Type Injury Patient Outcome Life Threatening;
Event Description
Reporter indicated that pt experienced an increase in seizure activity above pre-vns baseline frequency during a one week time period that this device was programmed to off due to feeling a burning sensation in his chest around the implant area. Pre-vns seizure frequency was reported to be 1 grand mal seizure every 4-6 weeks. When the increase in seizure activity occurred, the pt experienced 3 grand mal seizures during one week. Report is incomplete because no response has been received to manufacturer's requests for additional information from treating neurologist (via telephone x2 via fax x1).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=645386


Title: Re: Increase in seizures
Post by: dennis100 on December 05, 2011, 11:23:51 AM
Model Number 102
Event Date 10/18/2005
Event Type Injury Patient Outcome Life Threatening; Hospitalization Required Intervention
Manufacturer Narrative
H. 6: vns therapy system labeling lists nausea and vomiting as potential adverse events possibly associated with surgery or stimulation. Treating neurologist indicated that the pt experienced post anesthesia nausea and was subsequently unable to take her medications, which resulted in low antiepileptic drug levels.

Event Description
Reporter indicated that pt was hospitalized in intensive care unit nd on a ventilator following vns implant surgery. It was reported that the patient "was not been able to keep anything down" after implant surgery and that she had been experiencing seizures ever since implant surgery. The pt was reportedly discharged to home on the day of surgery and returned to hospital emergency room the following day due to increased in seizure activity. Stimulation had not yet been initiated at the time of the event, but was initiated one week later

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=645144



Title: Re: Increase in seizures
Post by: dennis100 on December 05, 2011, 11:24:36 AM
Model Number 102
Event Date 10/18/2005
Event Type Injury Patient Outcome Life Threatening; Hospitalization Required Intervention
Manufacturer Narrative
H. 6: vns therapy system labeling lists nausea and vomiting as potential adverse events possibly associated with surgery or stimulation. Treating neurologist indicated that the pt experienced post anesthesia nausea and was subsequently unable to take her medications, which resulted in low antiepileptic drug levels.

Event Description
Reporter indicated that pt was hospitalized in intensive care unit nd on a ventilator following vns implant surgery. It was reported that the patient "was not been able to keep anything down" after implant surgery and that she had been experiencing seizures ever since implant surgery. The pt was reportedly discharged to home on the day of surgery and returned to hospital emergency room the following day due to increased in seizure activity. Stimulation had not yet been initiated at the time of the event, but was initiated one week later

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=645144



Title: Re: Increase in seizures
Post by: dennis100 on December 05, 2011, 11:30:27 AM
Model Number 302-20
Event Date 01/01/2005
Event Type Malfunction Patient Outcome Life Threatening; Hospitalization
Event Description
Further follow up revealed that the replacement vns therapy system is functioning properly and the pt is beginning a new ramp up cycle. Besides the high impedance event, the treating facility also reported that another contribution to the increase in seizures was decreasing the depakote medication. The pt's depakote level has since been increased. Product analysis summary: the entire lead assembly was returned in pieces. Visual analysis identified two breaks in the negative coil at approx 1mm prior to and past the anchor tether. In addition, a break on the positive coil was seen past the anchor tether. The sillicone tubing had openings past the anchor tether at the area where the breaks are located. The lead coils were further analyzed using scanning electron microscopy. Electron microscopy found that the appearance of the coil wires in first break of the negative coil showed characteristics of a stress-unduced fracture. Inspection of the positive and negative (second) coil breaks showed that pitting or electro-plating conditions have occurred. Fracture mechanism could not be determined due to the pitting. It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting, howeverm, in all cases a conclusive determation were noted. The setscrew marks found on the lead connector pins showed evidence that, at one point in time, proper mechanical and electrical connection was present. Using a multi-meter, continuity checks of the lead was performed with no other discontinuities identified. Based on the product analysis findings, there is evidence to suggest the identified lead coil breaks would have contributed to the high impedance event. The concomitant device (pulse generator) was also returned and analyzed. The pulse generator met electical test specifications. The pulse generator did not show any condition that would have contributed to the reporte event. The exact cause of the lead break is unk. Possible causes of lead discontinuity are: 1} mechanical failure. 2} implant technique (use of suture; no strain relief). 3} "twiddler"(twisting of the lead). 4} violent seizure. 5} physical injury/accident.

Event Description
Further follow-up revealed that the vns system (generator and lead) were explanted and replaced. It was also reported that prior to surgery, high lead impedance was observed and there was no evidence of a generator/lead connection problem. However, there was a lot of scarring seen in the region where the electrodes wrap around the vagus. The surgeon believes that the high impedance was caused by a lead/vagus nerve interface due to the scarring. A new lead and generator were implanted, and impedance was reported to be ok. Post-operatively, the patient is experiencing discomfort in the neck. The surgeon reported that the discomfort is likely due to the removal of the intense scar tissue. To date, the devices have not been received by the manufacturer for analysis.

Event Description
Reporter indicated that device diagnostic testing at office visit resulted in high lead impedance reading (dc-dc code 7 and limit), indicating possible device malfunction. The elective replacement indicator was no, ruling out generator battery end of life as a possible cause of the high lead impedance test result. At the time that the device diagnostic test was performed, the pt was not exhibiting any clincial symptoms; however, two weeks later it was reported that the pt was hospitalized due to an increase in seizure activity. Medications had reprtedly been decreased during this time. Device diagnostic testing was previously performed approx three weeks prior to the high lead impedance test result and was within normal limits, indicating proper device function at that time. Review of x-rays by mfr did not reveal any obvious discontinuties the vns therapy system. Revision surgery is planned due to suspected generator/lead connection problem or lead break.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=644628



Title: Re: Increase in seizures
Post by: dennis100 on December 05, 2011, 11:32:17 AM
Model Number 300-20
Event Type Malfunction
Manufacturer Narrative
H. 6. Vns therapy system labeling states that the safety and efficacy in this therapy have not been systematically established for use in pt's with history or previous therapeutic brain surgery.

Event Description
Reporter indicated that pt underwent ncp system replacement surgery due to lead discontinuity and a subsequent increase in seizures activity approximately 8 months after undergoing generator replacement surgery. Both the lead and generator were replaced. Device diagnostic test results at the time of previous generator replacement surgery are not documented, therefore it is not known when the reported lead discontuinity occurred or whether the lead was damaged during the generator replacement surgery. Report is incomplete because 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=663091



Title: Re: Increase in seizures
Post by: dennis100 on December 05, 2011, 11:33:43 AM
Model Number 300-20
Event Date 01/01/2005
Event Type Malfunction Patient Outcome Life Threatening; Hospitalization Required Intervention
Event Description
Reporter indicated that vns pt underwent ncp system replacement surgery due to an increase in seizure activity above pre-vns baseline frequency. It was reported that device diagnostic testing performed approximately five months prior to replacement surgery was within normal limits, indicating proper device function at that time. The elective replacement indicator was no, indicating that the generator battery had not reached end of life at the time that the diagnostic testing was performed. The pt had not experienced any recent high stress, family problems, injuries/trauma, or medication changes that may have contributed to the increase in seizure activity. During the replacement surgery, the neurosugeon reportely noted a "suspicious lead fracture". A loss of vns therapy due to an apparent lead fracture is the likely cause of the reported increase in seizure activity; however, the cause of the reported lead break is unknown. The device was not returned to manufacturer for analysis.

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 over 12 years of age 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 over 12 years of age with partial onset seizures that are refractory to antiepileptic medications. Treating physician believes that the patient's increase in seizure frequency was related to the reported device malfunction.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=643754



Title: Re: Increase in seizures
Post by: dennis100 on December 05, 2011, 11:43:19 AM
Model Number 101
Event Date 04/01/2005
Event Type Injury Patient Outcome Life Threatening;
Event Description
Reporter indicated that the patient began having an increase in seizures over the past 6 months. The patient was concerned that his device may be nearing end of service. It is unknown if the seizure increase is above the patient's pre-vns baseline frequency

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=643472



Title: Re: Increase in seizures
Post by: dennis100 on December 05, 2011, 11:45:28 AM
Model Number 101
Event Date 09/01/2005
Event Type Injury Patient Outcome Life Threatening;
Event Description
The reporter indicated that the pt is experiencing an increase in seizures above her pre-vns baseline seizure frequency. The reporter also indicated that the device may be at ent of service (battery died). The cause of the increase in seizures is likely due to a dead generator battery; however, it is unknown why the seizure increase would be above the patients pre-vns baseline seizure frequency as the pt has had the device for approx 5 years. Report is incomplete because the pt did not have a current neurologist for the manufacturer to contact.

Event Description
Further follow-up revealed that device diagnostic testing was within normal limits, indicating proper device function. The elective replacement indicator was no. Indicating that the generator had not reached end of svc. Physician indicated that the pt has experienced a decrease in seizures and that the mothe is concerned about the device reaching end of svc. The pt will be monitored closely for signs of device end of svc.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=643402



Title: Re: Increase in seizures
Post by: dennis100 on December 05, 2011, 11:46:31 AM
Model Number 101
Event Date 12/01/2003
Event Type Injury Patient Outcome Life Threatening; Required Intervention
Manufacturer Narrative
The ncp 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 ncp system is approved for use in adults and adolescents with partial onset seizures that are refractory to antiepileptic medications. Additionally, ncp system labeling states that the safety and efficacy of this therapy have not been systematically established for use in patients with history or previous therapeutic brain surgery. Medications at time of event include: keppra 125 mg. Bid; zonegran 100 mg. 3 hs; tegretol xr 200 mg. 1 bid.

Event Description
Reporter indicated that pt experienced an increase in seizure activity, presumably above pre-vns baseline frequency. Stimulation was subsequently discontinued, after which the increase in seizure activity reportely resolved. Prior to vns implant and resective surgery, the pt's seizure frequency is documented as being 90 seizures per day. The pt underwent resection of tuberous sclerosis approximately 52 months post initial vns implant surgery and 26 months post generator replacement surgery, at which time stimulation was discontinued. During the first five months after the resective surgery and in the absence of the vns therapy, the pt's seizure frequency was reduced to 1-5 seizures per day and the patient sometimes went 17-22 days per month seizure-free, during the sixth month after resective surgery, the patient's seizure frequency began to increase, so vns therapy was reinitiated. After restarting device stimulation, the patient's seizure frequency increased further. Device stimulation was discontinued after which the increase in seizure activity reportedly increased. A possible cause of the event could be that programmed parameters were too high since the device had been programmed to off for six months following resective surgery and stimulation was reinitiated at 1. 0ma normal mode output current instead of titrating the stimulation from 0. 25ma with periodic increase. It is not known whether there were any medication changes at the time of the event that may have contributed to the increase in seizure activity. Additionally, it is possible that the increase in seizure activity was due to the patient's disease process possibly being altered following the resective surgery.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=642877



Title: Re: Increase in seizures
Post by: dennis100 on December 05, 2011, 11:49:03 AM
Model Number 300-20
Event Date 01/01/2005
Event Type Malfunction Patient Outcome Life Threatening;
Event Description
The concomitatn device (pulse generator) was returned and ananlyzed. The pulse generator was interrogated and the elective replacement indicator was yes, indicating that the generator had reached end of service. The pulse generator failed electrical test. This is expected due to the generator being at end of life. The battery was detached and a power supply set to 2. 2v was attached. The serial number restored and the module interrogated and programmed properly. Generator end of life is a likely cause of the high lead impednace condition; however, since the lead was discarded after explant, it is unknown if a lead malfunction also occurred.

Manufacturer Narrative
The vns therapy system is indicated for use as an adjective therapy in reducing the frequency of seizures in adults and adolescent with partial onset seizures that are refractory to antiepileptic medication. In the unites states, the vns therapy system is approved for use in adults and adolescents age with partial onset seizures that ere refactory to antiepileptic medications. The pt was not taking any anti-epileptic medications at the time of the reported event.

Event Description
Reporter indicated that device diagnostic testing resulted in high lead impedance reading (dc-dc code 7 and limit) indicating possible device malfunction. This elective replacement indicator was no, ruling out generator battery end of life as a likely cause of high lead impedence test result. It was also reported that the pt was seen in hospital emergency room for treatment of breakthrough seizures at the time of the high lead impedance test result and that the pt experienced an increase in seizure activity above pre-vns baseline. Review of x-rays by treating physician did not reveal any obvious discontinuities in the ncp system. The pt underwent ncp system replacement surgery, during which both the lead and generator were replaced. Further follow-up revealed that the pt's condition has reportedly improved since ncp system replacement surgery. Lead break is suspected but cannot be confirmed because the original lead was discarded after explant

.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=642480



Title: Re: Increase in seizures
Post by: dennis100 on December 05, 2011, 11:49:54 AM
Model Number 101
Event Date 08/01/2005
Event Type Injury Patient Outcome Required Intervention;
Manufacturer Narrative
This date is estimated, only the month/year is known.

Event Description
Reporter indicated that vns patient has experienced a recent increase in seizure activity. Treating neurologist did not know whether the increase was above the pre-vns baseline frequency as she had inherited the patient from another physician. However, the physician indicated that prior to the increase the patient experienced approximately five seizures per month and now she is experiencing 1-2 per day. It was reported that normal mode output current setting was increased from 1. 5ma to 1. 75ma with no improvement. Device diagnostic testing was reportedly within normal limits, indicating proper device function. The elective replacement indicator was no, indicating that the generator battery had not reached end of life.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=642034




Title: Re: Increase in seizures
Post by: dennis100 on December 05, 2011, 11:50:38 AM
Model Number 102
Event Date 06/01/2005
Event Type Injury Patient Outcome Life Threatening;
Event Description
Reporter indicated that vns patient has experienced an increase in seizure activity since implant. Stimulation was not initiated until approximately two months post-implant. The patient has never been able to feel device stimulation, even when output current was increased to highest setting (3. 5ma). Device diagnostic testing was within normal limits, inicating proper device function. Report is incomplete because no reponse has been received to manufacturer's requests for additional information from treating neurologist (via telephone x2, via email x1, via face-to-face visit to office x1). Additionally, device tracking information was not forwarded to manufacturer at time of initial implant.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=640735



Title: Re: Increase in seizures
Post by: dennis100 on December 05, 2011, 11:51:38 AM
Model Number 102
Event Date 08/29/2005
Event Type Injury Patient Outcome Life Threatening;
Event Description
Further follow-up revealed that there have been no changes in medications or any environmenal stimuli that could have caused the increase in seizures. Neurologist indicated that device settings were increased to. 5ma one week post implant and decreased back to. 025ma approx two weeks later. Neurologist reported that the pt's seizures have decreased and that vns therapy may possibly be related to the increase in seizures. Neurologist also indicated that the pt experienced periodic events of increased seizures prior to being implanted with the vns therapy systems.

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 over 12 years of age 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 over 12 years of age with partial onset seizures that are refractory to antiepileptic medications. Vns therapy system labeling cautions not to program the vns therapy system to an on or periodic stimulation treatment for at least 14 days after the initial or replacement implantation. Failure to observe this precaution may result in patient discomfort or adverse events. Additionally, labeling states that during the first few weeks after implantation, the patient should be seen to confirm wound healing and proper pulse generator operation. The pulse generator's output current for both the magnet and the programmed stimulation must be 0. 0 ma for the first 14 days after implantation. Additionally, vns therapy system labeling states to always use the tie-downs and to loosely attach the 3-cm strain relief bend to the adjacent fascia with tie-downs before routing the lead over the muscle. The lead wire has a potential for fracture if the recommended 3-cm strain relief bend is not provided as described. Additionally, device labeling lists improper surgical implantation of the vns therapy system, (but not limited to) providing an inadequate strain relief loop, placing sutures directly on the lead body, not using the tie-downs, and suturing to muscle as events that can shorten the life expectancy of the lead.

Event Description
Reporter indicated that vns patient has experienced an increase in seizure activity, presumably above pre-vns baseline frequency. It was reported that stimulation was initiated at the time of initial implant surgery (normal mode output current set to 0. 25ma). Device diagnostic testing at time of initial implant surgery was reportedly within normal limits, indicating proper device function. Implanting surgeon refused to use tie-downs to secure the lead, citing cosmetic reasons. Report is incomplete because no response has been received to manufacturer's requests for additional information from treating neurologist (via fax x2).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=640773



Title: Re: Increase in seizures
Post by: dennis100 on December 05, 2011, 11:53:46 AM
Model Number 302-20
Event Type Malfunction
Event Description
Further follow-up revealed that the pt underwent vns therapy system replacement. Both the pulse generator and bipolar lead were replaced. The lead electrodes were not removed due to fibrosis encapsulation.

Manufacturer Narrative
H. 6. : vns therapy system labeling cautions that pts who manipulate the pulse generator and bipolar lead through the skin may damage or disconnect the bipolar lead from the pulse generator and/or possibly cause damage to the vagus nerve.

Event Description
Reporter indicated that treating physician ordered a chest x-ray due to suspected lead break because the pt has been experiencing an increase in seizure activity. Treating neurologist later indicated that upon review of the x-rays, the lead body appeard to be "twisted. " it was reported that the twisted appearance of the lead via x-ray was consistent with conditions that exist when the device is manupulated through the skin. Device diagnostic testing resulted in high lead impecance reading (dc-dc code 7), indicating possible device malfunction. Revision surgery is planned. Review of mfg records for the bipolar lead revealed no anomalies that would adversely affect device performance.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=663584




Title: Re: Increase in seizures
Post by: dennis100 on December 05, 2011, 11:55:38 AM
Event Type Injury Patient Outcome Life Threatening;
Event Description
Manufacturer became aware of a published clinical article summarizing the author's experience with vagus nerve stimulation as a neurophysiologic treatment for patients with refractory epilepsy. The article discusses a study on 15 epilepsy patients and indicates that 2 of 15 patients experienced an increase in seizure frequency with the vns therapy.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=643726



Title: Re: Increase in seizures
Post by: dennis100 on December 05, 2011, 11:56:43 AM
Model Number 300-20
Event Type Malfunction
Event Description
Reporter indicated that vns patient underwent ncp system replacement surgery due to suspected lead break. It was reported that the patient began to experience an increase in seizure activity approximately four months prior to ncp system replacement surgery. Device diagnostic testing performed two months prior to ncp system replacement surgery resuled in high lead impedance reading (dc-dc code 7), indicating possible device malfunction. Device diagnostic testing performed on the day of replacement surgery (prior to replacement) also yielded high lead impedance results (dc-dc code 7 and limit). The elective replacement indicator was no, ruling out generator battery end of life as a possible cause of the high lead impedance test results. Review of manufacturing records for both the pulse generator and the bipolar lead revealed no anomalies that would adversely affect device performance.  

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=663432



Title: Re: Increase in seizures
Post by: dennis100 on December 06, 2011, 01:18:00 AM
Model Number 300-20
Event Type Malfunction
Event Description
Reporter indicated that the device diagnostic testing at office visit resulted in high lead impedance reading (dc-dc code 7 and limit), indicating possible device malfunction. The elective replacement indicator was no, ruling out generator battery end of life as a likely cause of the high lead inpedance test result. Prior to obtaining the high lead impedance result, the patient experienced infrequent seizures with the vns therapy, but has since experinced approximattely three seizures per day. The patient has not experienced any recent injury or trauma that may have damaged the ncp system and does not manipulate the device through the skin. Review of x-rays by mfr revealed that hte lead electrodes appear to be implanted at the c5-c6 level. The strain relief bend and loop appeared to be adequate. Three tie downs were noted. No obvious lead breaks were noted; however, the entirety of the lead body could not be seen as some of the lead was under the generator, so a lead fracture in that area could not be ruled out. The lead connector pin appear to be past the generator connector block. The patient's device was disable pending surgical consult. Lead break is suspected. Revision surgery is likely; however, no surgical procedure is planned at this time as the patient is reportedly doing a lot better since the device was disabled.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=675854




Title: Re: Increase in seizures
Post by: dennis100 on December 06, 2011, 01:20:43 AM
Model Number 300-20
Event Type Malfunction
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 over 12 years of age with partial onset seizures that are refractory to antiepileptic medications.

Event Description
Device diagnostic testing at office visit resulted in high lead impedance reading indicating possible device malfunction. The elective replacement indicator was no, ruling out generator battery end of life as a likely cause of the high lead impedance test result. It was reported that high lead impedance test result was also obtained at previous office approximately 11 months prior and that the patient has experienced in increase in seizure activity, though not believed to be an increase above pre-vns baseline frequency. Review of x-rays by manufacturer revealed that the generator was fairly well noticeable and the placement of it was normal. Both lead connector pins were fully inserted into the generator and the filter feed throughs were both intact. The lead could not be seen clearly, and also the area of olectrode attachment and strain relief were not present in the x-ray at all. There was also a portion of the lead behind the generator. In the section of lead that could be seen, no lead discontinuities or sharp angles were noted. The lead wires appeared to be intact at the connector pins. Treating neurologist is not sure whether the patient had suffered any injury or trauma that may have damaged the vns therapy system or whether the patient manipulated the device through the skin, but the indicated that he wouldn't rule it out as a possibility because the patient is severely developmentally delayed. Treating neurologist indicated that it was possible that the patient may have reached up to the generator or lead, but it was unknown since there has been no reported incidents by her careprovider. The patient does not speak, therefore it is unknown whether she can feel stimulation of not. The patient was referredfor surgical consult. Lead break is suspected.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=677670



Title: Re: Increase in seizures
Post by: dennis100 on December 06, 2011, 01:21:55 AM
Model Number 102
Event Date 01/05/2006
Event Type Injury Patient Outcome Hospitalization; Required Intervention
Manufacturer Narrative
H. 6. Treating physician does not believe that the increase in seizure activity is related to the vns therapy system. The most likely cause of the increase in seizure activity is inadequate settings because the seizures resolved after parameter changes.

Event Description
Vns pt was hospitalized, because he had experiencd 5 grand mal seizures. The pt was reportedly seizure-free for six months prior to the event and only experienced 1-2 grand mal seizures every 3-4 months prior to vns implant. Further follow-up revealed that the pt's increase in seizure activity has ceased. Both normal mode and magnet mode outputs currents were increased to 1. 5ma. There were no medication changes or environmental stimuli that could have prompted the increase in seizure activity and device diagnostic testing was within normal limits, indicating proper device function. Treating physician indicated that potential seizure triggers had been identified but did not elaborate on what those triggers were. Treating phsyician does not feel that the increase in seizure activity was related to the vns therapy. The most likely cause of the increase in seizure activity is inadequate settings because the seizures resolved after parameter changes.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=679473



Title: Re: Increase in seizures
Post by: dennis100 on December 06, 2011, 01:23:13 AM
Model Number 102
Event Type Malfunction
Event Description
Reporter indicated that pt was seen by physician due to an increase in eizure actibity (not above pre-vns baseline frequency), at which time device interrogation revealed that off time was set to 60 mins, instead of to precribed parameter (5 mins off time). The pt's device was reprogrammed to prescribed settings. There had been a recent change in the pt's medication regimen, so treating physician was not sure whether the increase in seizure activity was related to the vns therapy or to the change in medications. Treating physician indicated that she always runs a final interrogation to check the settings after any programming or diagnostic event, but said that it was possible that she may not have noticed a change in the off time setting. User error during previous programming session is suspected.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=680558



Title: Re: Increase in seizures
Post by: dennis100 on December 06, 2011, 01:24:38 AM
Model Number 300-20 Event Type Malfunction
Event Description
Reporter indicated that device diagnostic testing at office visit resulted in high lead impedance reading (dc-dc code 7 and limit), indicating possible device malfunction. The elective replacement indicator was no, ruling out generator battery end of life as a likely cause of the high lead impedance test result. The patient indicated that she had experienced an increase in seizure activity, but it was unknown whether the increase was above pre-vns baseline frequency. The patient's device seemed to be working properly as indicated by clear voice change during stimulation cycles. The patient had not experienced any recent injury or trauma that may have damaged the ncp system. Review of x-rays by manufacturer revealed that the lead electrodes were implanted at c5-c6 with two tie downs and strain relief noted. The lead connector pins appeared to be fully inserted past the generator connector blocks with feedthroughs intact and lead wire intact at the conncector pin. There were no visible gross lead discontinuities or acute angles along the enitrety of the lead; however, due to poor contrast next to the lead and connector pin joint and some portion of the lead lying behind the generator, a lead discontinuity in that location could not be ruled out. The patient underwent revision surgery, during which the lead was disconnected from the generator. The surgeon indicated that there appearedto be fluid or material in the negative port. The surgeon cleaned out the header with saline and dried the inside with sterile q-tips. Device diagnostic testing of the generator alone was within normal limits, indicating a potential lead break, lead/nerve interface issue, or generator/lead connection problem. The lead was reconnected to the generator, after which device diagnostic testing again resulted in high lead impedance reading. The surgeon then dissected the neck site, upon which lots of fibrosis was noted. Noth the lead (including electrodes) and generator were replaced. Upon explant, the surgeon noted that there was a portion of the lead that appeared to be broken near one of the electrodes, perhaps at the weld spot where the lead conductor meets the electrode. It was impossible to visually inspect the remainder of the lead as it was covered by much fibrosis.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=680676



Title: Re: Increase in seizures
Post by: dennis100 on December 06, 2011, 01:25:55 AM
Model Number 102
Event Date 12/21/2005
Event Type Malfunction
Manufacturer Narrative
H6: vns therapy system labeling recommends interrogating the pulse generator as the last step of any programming session to verify correct settings for each parameter.

Event Description
Vns patient experienced an increase in seizure activity (not above pre-vns baseline frequency) due to an inadvertent change in device settings. Two days before the increase in seizure activity, the patient was seen by treating physician, at which time device diagnostic testing was reportedly within normal limits, indicating proper device function. At the time of that office visit, the device was set to 2. 5ma normal mode output current, 30secs on, 3 mins off. At subsequent office visit three days after the increase in seizure activity occurred, device interrogation revealed that settings had inadvertently changed to 1. 0ma normal mode output current, 60secs on, and 5 mins off. It is believed that an interrupted device diagnostic test at previous office visit caused the inadvertent change in device settings. A review of device programming history did not reveal any evidence of an interrupted device diagnostic test at previous office visit; however, the settings that the device was inadvertently changed to are consistent with settings seen after an interrupted lead test. Whether a fault result is recorded in device programming history is dependent upon at which point in the lead test procedure the interruption in communication occurs; therefore, it is possible that an interrupted lead test did occur and that this occurrence was not captured in the device programming history data. The device was reprogrammed to prescribed settings. After which the patient is reportedly doing well.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=679602



Title: Re: Increase in seizures
Post by: dennis100 on December 06, 2011, 01:26:56 AM
Model Number 102
Event Type Injury Patient Outcome Life Threatening;
Event Description
Reporter indicated that vns pt was experiencing an increase in seizure activity above pre-vns baseline frequency. The pt reportedly experienced a seizure every 6-8 wks prior to vns implant and is now experiencing a seizure every 2 wks. The pt reports that his seizures usually occur at night and that they are rough. The pt reports that he has no chance to use the magnet before a seizure as he is in deep sleep when they occur. Report is incomplete because no response has been received to manufacturer's requests for additional info from treating neurologist.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=674051



Title: Re: Increase in seizures
Post by: dennis100 on December 06, 2011, 01:28:12 AM
Model Number 101
Event Date 10/01/2005
Event Type Injury Patient Outcome Life Threatening;
Manufacturer Narrative
Ncp system labeling stated that the safety and efficacy of this therapy have not been systematically established for use in patients with history of previous therapeutic brain surgery.

Event Description
Reporter indicated that vns patient was experienceng an increase in seizure activity above pre-vns baseline frequency. It was reported that the patient's seizure rate has progressively inceased over the past three months such that he is now experiencing seizures daily. Device diagnostic testing was within normal limits, indicating proper device function. The elective replacement indicator was no, ruling out generator battery end of life as a likely cause of the reported event. It was reported that the increase in seizure activity may be related to low sodium levels and that lab work was planned in order to confirm. There have been no recent medication changes that may have contributed to the increase in seizure activity, which continues despite adjustments to programmed parameters. The patient's overall health condition is not worsening and there are reportedly no environmental stimuli that could have caused the increase in seizure activity.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=673029



Title: Re: Increase in seizures
Post by: dennis100 on December 06, 2011, 01:29:03 AM
Model Number 102
Event Date 11/01/2005
Event Type Injury Patient Outcome Hospitalization;
Event Description
Reporter indicated that the patient has experienced an increase in seizures. The patient was having approximately 7 seizures per month and recently had 30 seizures in one month. It was also reported that the patient required hospitalization in late november for newly diagnosed insulin dependent diabetes. It is unknown if the seizure increase is related to the vns therapy. Report is incomplete due to lack of information from the treating physician. Two attempts (faxes) have been sent to gather information; however, the treating physician did not respond.

Event Description
No conclusion can be drawn regarding the reported events; however, it is felt that the pt's new diagnosis of iddm is a contributing factor. Iddm is a serious disease process that require daily blood monitoring and insulin shots. This is traumatic and stressful for a juvenile pt and could potentially cause an increase in seizures. Additionally, there are other potential causes that could not be ruled out such as non-therapeutic aed levels, non-therapeutic vns therapy and generator or lead malfunction

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=672749



Title: Re: Increase in seizures
Post by: dennis100 on December 06, 2011, 01:30:30 AM
Model Number 102
Event Date 01/01/2005
Event Type Injury Patient Outcome Life Threatening;
Event Description
Vns pt has experienced a recent increase in seizure activity. It is not known whether the increase is above pre-vns baseline frequency. The pt was reportedly an amazing responder to the vns therapy for 10 months prior to the increase in seizure activity. Based on known device settings, generator battery end of life is not likely. Device diagnostic testing was within normal limits, indicating proper device function.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=671326



Title: Re: Increase in seizures
Post by: dennis100 on December 06, 2011, 01:31:36 AM
Model Number 101
Event Type Malfunction
Event Description
Further follow-up revealed that the device is working properly and the output current was increased.

Event Description
Reporter indicated that when the patient's device is swiped with the magnet, he continues to seize. It was reported that in the past, a magnet swipe would abort or lessen the patient's seizures. It was also reported that the patient's seizures are more intense than they have been with vns therapy and that his seizures have increased from lasting approximately 1 min to now lasting approx 30 mins. Treating neurologist has been unable to perform device diagnostic testing because the patient cannot sit still. The patient is mentally retarded and reportedly pushes examiner away, even after heavy sedation. Based on known device settings, generator battery end of life is not likely. Treating physician plans to attempt device diagnostic testing when the patient is asleep. Investigation to date has been unable to determine if the device is functioning properly.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=673992



Title: Re: Increase in seizures
Post by: dennis100 on December 06, 2011, 01:32:44 AM
Model Number 101
Event Date 12/29/2005
Event Type Injury Patient Outcome Life Threatening;

Event Description
Vns patient felt as though her battery was going dead and that she could 'feel her seizures coming, more and more'. The pt reported that she began feeling more seizueres coming on and that she felt dizzy and couldn't see very well, but that she could still feel device stimulation, though not as strong. Investigation to date has been unable to determine the severity of the event as no responses have been received to manufacturer's request for additional information from treating neurologists (via fax x2. ).

Event Description
Further follow up from the treating neurologist indicated that the pt's cause of increase in seizures was due to stress of family issues. The reported increase in seizures was not an increase above pre-vns seizure baseline. There were no changes to medications or vns parameters. Pt is currently stable.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=669395



Title: Re: Increase in seizures
Post by: dennis100 on December 06, 2011, 01:33:39 AM
Model Number 300-20
Event Type Malfunction
Event Description
The lead was returned and analyzed. Product analysis summary: the reported lead discontinuity was duplicated. The condition of the returned portion of the lead is consistent with conditions that typically exist following an explant procedure. The lead pins showed evidence of a proper mechanical and electrical connection as expected. A coil break was observed on the lead coils at the end of the electrode bifurcation. Due to metal dissolution and mechanical distortion the fracture mechanism cannot be ascertained. It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting on the broken coil wires. The physician had previously reported seeing a lead pin/generator connector issue. The connector issue was not observed in analysis. The cause of the lead break is unknown. Possible lead break causes include: 1) mechanical failure; 2) implant technique (use of suture; no strain relief); 3) twisting of the lead; 4) violent seizure; or 5) physical injury/accident.

Manufacturer Narrative
The vns therapy system is indicated for use as an adjunctive therapy in reducing the frequency of seizures in adults and adolescents over 12 years of age 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 adolesents over 12 years of age with partial onset seizures that are refractory to antiepileptic medications.

Event Description
Vns pt underwent vns therapy system replacement surgery due to lead discontinuity. It was reported that the lead discontinuity was discovered during a `routine vns check,' presumably as a result of high lead impedance test result from device diagnostic testing. Additionally, the pt had reportedly experienced a minor increase in seizure activity prior to vns therapy system replacement surgery. Review of x-rays by treating physician reportedly revealed that the lead connector pin had become disconnected from the generator connector block. The pt is diagnosed with aicardi syndrome and treating physician indicated that it is unknown whether this condition was a contributing factor to the generator/lead disconnection issue.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=669850



Title: Re: Increase in seizures
Post by: dennis100 on December 06, 2011, 01:34:48 AM
Model Number 300-20
Event Type Malfunction
Event Description
Device diagnostic testing at office visit resulted in high lead impedance reading (dc-dc code 7 and limit), indicating possible device malfunction. It was also reported that the pt could no longer feel device stimulation and that she was experiencing `a few more auras than usual. ' the elective replacement indicator was no, ruling out generator battery end of life as a likely cause of the high lead impedance test result. Previous device diagnostic testing performed approximately 6 months prior was within normal limits, indicating proper device function at that time. Treating physician was not aware of any recent injury or trauma that the pt may have suffered that would possibly have damaged the ncp system. The pt attributes the increase in the frequency of auras to stress from a recent divorce. Review of x-rays by treating physician did not reveal any obvious discontinuities in the ncp system. Review of x-rays by manufacturer revealed that the lead electrodes are placed at c3-c4 level. Three tie-downs were noted. Strain relief appeared to be adequate. Lead connector pins were fully inserted into the generator connector block. No visual gross fractures or sharp angles were noted; however, some of the lead was behind the generator so a lead break in that area could not be ruled out. Lead break or lead/nerve interface problem is suspected. Revision surgery is likely. Report is incomplete because no response has been received to manufacturer's requests for additional information from treating neurologist.

Manufacturer Narrative
Information obtained during the investigation of the reported event reasonably suggests that a lead fracture is the cause of the high lead impedance test result.

Event Description
The patient underwent ncp system replacement surgery, during which both the lead and generator were replaced. Device tracking information submitted to manufacturer for the replacement vns therapy system indicated that the replacement surgery was performed due to lead discontinuity. It was reported that the explanted devices would not be returned to manufacturer for analysis because they were discarded.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=669939



Title: Re: Increase in seizures
Post by: dennis100 on December 06, 2011, 01:36:41 AM
Model Number 101
Event Date 01/01/2005
Event Type Injury Patient Outcome Life Threatening;
Event Description
Vns pt was experiencing an increase in seizure activity. Treating physician does not know whether the increase is above pre-vns baseline frequency because the pt is new to the office. Based on known device settings, generator battery end of life is not a likely cause of the reported increase in seizure activity.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=667549


Title: Re: Increase in seizures
Post by: dennis100 on December 06, 2011, 01:37:23 AM
Model Number 102
Event Date 04/01/2005
Event Type Injury Patient Outcome Life Threatening;
Event Description
Reporter indicated that patient's seizure type has changed from absence seizures to grand mal seizures since the patient experienced a fall. Device diagnostic testing was within normal limits, indicating proper device function and review of x-rays did not reveal any obvious discontinuties in the vns therapy system. It was also reported that the patient experiences wheezing at night when she lays down.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=665007


Title: Re: Increase in seizures
Post by: dennis100 on December 06, 2011, 01:38:17 AM
Model Number 101
Event Date 01/01/2005
Event Type Injury Patient Outcome Required Intervention; Life Threatening
Event Description
Reporter indicated that vns patient was experiencing an increase in seizure activity. Treating physician reportedly feels like device settings are already aggressive, so he made changes to the patient's drug regimen to treat the increase in seizure activity. Device diagnostic testing was within normal limits, indicating proper device function. The elective replacement indicator was no, ruling generator battery end of life as likely cause of the increase in seizure activity. Investigation to date has been unable to determine whether the increase in seizure activity was above pre-vns baseline frequency because no response has been received to manufacturer's requests for additional information from treating physician.

Event Description
The treating physician indicated that he did not believe the patient was experiencing a problem with the vns therapy. He also indicated that he was not going to respond to the manufacturer's questions regarding this event.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=662805



Title: Re: Increase in seizures
Post by: dennis100 on December 06, 2011, 01:39:05 AM
Model Number 300-20
Event Type Malfunction
Event Description
Further follow-up revealed that a decision to replace the device has not been made. The patient has been referred for corpus callostomy surgery. The decision to undergo that brain surgery or replace the vns device has not been made. The reported seizure increase is likely due to the patient no longer receiving the vns therapy. The cause of the reported high impedance is unknown. Possible causes of high impedance include:broken lead, patient movements, bad connection, electrode to vagus nerve interface, approaching end-of-service, physician/patient training, possibility of damage during mfg, design durability, or corrosion.

Manufacturer Narrative
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 patient underwent generator replacement surgery due to high impedance reading during device diagnostic testing at office visit (dc-dc code 7 and limit). Device diagnostic testing performed at office visit after generator replacement surgery also resulted in high lead impedance reading (dc-dc code 7 and limit), indicating possible malfunction of the original biplolar lead. It was also reported that the patient was experiencing an increase in seizure activity above pre-vns baseline frequency. It was reported that intraoperative device diagnostic testing at the time of generator replacement surgery (with replacement generator connected to original lead) was within normal limits, indicating proper device function at that time. Review of x-rays by manufacturer revealed that the lead electrodes were implanted at the c5-c6 level with little strain relief noted. There was a possible small lead discontinuity after the lead bifurcation at the strain relief bend under c6 that appeared visible in two x-rays when patient's head was turned. The generator was implanted in the left chest with lead connector pins fully inserted past the generator connector block and feedthroughs intact as well as lead wire intact at the connector pin. The patient had not experienced any recent injury or trauma that may have damaged the ncp system and it is not believed that the patient manipulated the device through the skin. Revision surgery is likely.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=663008


Title: Re: Increase in seizures
Post by: dennis100 on December 06, 2011, 01:40:13 AM
Model Number 302-20
Event Type Malfunction Patient Outcome Life Threatening;
Event Description
Reporter indicated that device diagnostic testing performed at office visit resulted in high lead impedance reading (specifics unk), indicating possible device malfunction. It was also reported that the pt is experiencing an increase in seizure activity and an 'electrial shocking pain in the chest. ' revision surgery to reposition the generator is being considered because the pt has frequent mammograms in the area where the device is currently located. It is believed that the mammography has caused migration of the generator. Report is icomplete beause no response has been received to manufacturer's requests for additional info from treating neurologist. Leak break or generator/lead connection problem is suspected.

Event Description
Further follow-up revealed that the patient underwent vns therapy system replacement surgery, during which both the lead and generator were replaced. It was reported that it had been determined that the lead was not f unctioning and the physician "determined that the lead was not allowing the stimulation to be delivered".

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=660600



Title: Re: Increase in seizures
Post by: dennis100 on December 06, 2011, 01:41:09 AM
Model Number 102
Event Date 12/01/2005
Event Type Injury Patient Outcome Life Threatening; Required Intervention
Event Description
Reporter indicated that vns patient has recently experienced an increase in seizure activity above pre-vns baseline frequency. It was reported that the patient could no longer feel normal mode or magnet mode device stimulation. The patient suffered a fall approximately three months prior, after which she was on crutches. Use of the crutches reportedly caused the patient to experience a tingling in her armpit. The patient's device was programmed to off for approximately three weeks due to the tingling sensation, but was programmed back to on approximately two weeks before the increase in seizure activity began. When the device was first programmed back to on, the patient felt 'mild stimulation' while in the neurologist's office, but no longer feels device stimulation. Device diagnostic testing performed at that office visit was within normal limits, indicating proper device function. It was reported that medications were prescribed to treat the increase in seizure activity. The patient has since changed neurologists. Report is incomplete because no response has been received to manufacturer's requests for additional information from last known neurologist.

Event Description
Further follow-up revealed that the patient also previously reported that the magnet was not always effective in stopping her seizure. The physician reported that device diagnostics resulted in normal and he had changed the generator settings; however, this old eliminate the patient's arm tingling symptoms. The physician also reported that the patient's seizures were above her pre-vns baseline frequency. The physician told the manufacturer that he did not want to provide any further information and would not respond to the written requests due to hipaa. It was further reported that since the patient's fall she had experienced an increase in seizures and intermittent "jolts" in her chest when the devices stimulates. The patient also feels stimulation in her neck. Revision surgery were performed. Only the pulse generator was replaced. The surgeon noted that he observed fluid the lead tubing but the lead testing was ok. It was also reported that since the pulse generator replacement, the patient has had no seizures and is very happy with replacement. The cause of the seizure increase, erratic stimulation, jolts at generator site and left arm tingling are unknown. The cause may have been from an improper lead/generator connection. The manfacturer expects the pulse generator to be returned or analysis.

Event Description
The explanted pulse generator was returned to manufucaturer for analysis. The elective replacement indictor was no, indicating was no, indicating that the pulse generator battyer had not reached end of life. Based on known device settings, the generator battery would not have reached end of life for 0. 88 more years. Use of magnet did stop normal mode stimulation and did initiate magnet mode stimulation and did initiate magnet mode stimulation cycles as intendes. No performance anomalies or any other conditions that may have contributed to the reported events were noted during visual or electrical testing. No instances of erratic stimulation were noted.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=660590



Title: Re: Increase in seizures
Post by: dennis100 on December 06, 2011, 01:42:27 AM
Model Number 102R
Event Date 11/22/2005
Event Type Injury Patient Outcome Life Threatening;
Manufacturer Narrative
Ncp system labeling states that the safety and efficacy of this therapy have not been systematically established for use in patients with history of previous therapeutic brain surgery.

Event Description
Reporter indicated that device stimulation seemed to trigger the patient's seizures after an increase in programmed parameters. It was reported that the patient seemed to tolerate device settings at 1. 75ma normal mode output current; 20hz frequency; 500upsec pulse width; 30sec on; 1. 8min off, but that since the normal mode output current was increased to 2. 0ma, the patient has been very agitated and the patient's family member believes that her seizures might be being triggered by the stimulation. Report is incomplete because no response has been received to manufacturer's request for additional information from treating neurologist (via fax x1).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=658918



Title: Re: Increase in seizures
Post by: dennis100 on December 06, 2011, 01:43:12 AM
Model Number 300-20
Event Type Malfunction
Event Description
Reporter indicated that vns patient is experiencing an increase in seizure activity and does not think his vns therapy system is working anymore. The patient reportedly believes that his generator battery has reached end of life. The patient was seen by treating neurologist at which itme device diagnostic testing resulted in high lead impedance reading (specifics unknown), indicating possible device malfunction. The electtive replacement indicator was no, ruling out generator battery end of life as the likely cause of the high lead impedance test result. Lead break is suspected. Revision surgery is likely.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=660391



Title: Re: Increase in seizures
Post by: dennis100 on December 07, 2011, 05:01:31 AM
Model Number 302-20
Event Date 01/01/2006
Event Type Malfunction
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.

Event Description
Reporter indicated that device diagnostics at a routine office visit resulted in high lead impedance indicating a possible lead break. The patient's mother reported an increase in seizure activity in the months preceeding the discovery of high impedance. The patient has not experienced any recent injury or trauma to the device area. Lead break is suspected. Revision surgery is likely. No serious injury was reported.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=834991



Title: Re: Increase in seizures
Post by: dennis100 on December 07, 2011, 05:02:19 AM
Model Number 300-20
 Event Date 12/13/2006
 Event Type Malfunction
Manufacturer Narrative
Pa and lateral of neck and chest x-rays were reviewed. No anomalies were noted on the x-rays. Device failure is suspected but did not cause or contribute to a death or serious injury.

Event Description
Reporter indicated that pt was experiencing an increase in seizures and does not feel stimulation. Device diagnostic testing yielded high lead impedance at an office visit. Review of x-rays by mfr did not reveal any anomalies. Revision surgery is likely. No serious injury was reported.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=827219



Title: Re: Increase in seizures
Post by: dennis100 on December 12, 2011, 08:37:10 AM
Model Number 101
Event Date 04/05/2007
Event Type Injury Patient Outcome Hospitalization;
 
Event Description
Reporter indicated a pt had been hospitalized for a recent increase in seizure activity. It is not known if the seizures are greater than pre-vns baseline levels. No further info is known.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=845068



Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 12, 2011, 09:54:19 AM
Model Number 300-20
Event Date 03/01/2007
Event Type Malfunction
Manufacturer Narrative
Device malfunction occurred, but did not cause or contribute to a death or serious injury.

Event Description
Reporter indicated that, the pt is experiencing no efficacy, daily seizures and high lead impedance on the normal mode diagnostic test. During clinic visit, system diagnostics resulted in high lead impedance indicating a possible lead malfunction. X-rays received and reviewed by mfr showed a lead break below the positive electrode. Revision surgery is likely. No serious injury was reported.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=962915



Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 12, 2011, 09:54:51 AM
Model Number 101
Event Date 04/05/2007
Event Type Injury Patient Outcome Hospitalization;

Event Description
Reporter indicated a pt had been hospitalized for a recent increase in seizure activity. It is not known if the seizures are greater than pre-vns baseline levels. No further info is known.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=845068




Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 12, 2011, 09:55:27 AM
Model Number 300-20
Event Date 03/01/2007
Event Type Malfunction
Manufacturer Narrative
Device malfunction occurred, but did not cause or contribute to a death or serious injury.

Event Description
Reporter indicated that, the pt is experiencing no efficacy, daily seizures and high lead impedance on the normal mode diagnostic test. During clinic visit, system diagnostics resulted in high lead impedance indicating a possible lead malfunction. X-rays received and reviewed by mfr showed a lead break below the positive electrode. Revision surgery is likely. No serious injury was reported.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=962915



Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 12, 2011, 09:55:56 AM
Model Number 101
Event Date 01/01/2007

Event Type Injury Patient Outcome Other;
Event Description
Reporter indicated that the pt was experiencing an increase in seizures, above pre-vns baseline. The physician reported that he believes the generator may be nearing end-of-service. A battery life calculation indicated that the generator should be at end-of-service based on the pt's programming history. Diagnostics indicate that generator is delivering programmed setting. Diagnostics also indicate that generator is not at end of service. Generator replacement surgery is planned because the physician believes the generator is at end of service and is resulting in the increase in seizures.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=851379



Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 12, 2011, 09:56:28 AM
Model Number 302-20
Event Date 04/12/2007
Event Type Malfunction
Manufacturer Narrative
Review of x-rays by mfr revealed that the strain relief appeared to be inadequate per cyberonics labeling recommendations. A device malfunction is suspected, but did not cause or contribute to death or serious injury.

Event Description
Reporter indicated that a systems diagnostics test at a routine office visit resulted in high lead impedance indicating a possible lead problem. The pt had an increase in seizure activity, below pre-vns baseline, since the last office visit. The reporter indicated that the believed cause of the increase in seizures could be due to a decreased in medication or the device not delivering the intended therapy. Review of x-rays by mfr revealed that the strain relief bend appeared to be inadequate per cyberonics labeling recommendations. Revision surgery is scheduled. No serious injury was reported.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=967884




Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 12, 2011, 09:57:03 AM
Model Number 100
Event Date 01/01/2007
Event Type Injury Patient Outcome Hospitalization;
Event Description
Reporter indicated that the patient was experiencing an increase in seizures, unk if above or below pre-vns baseline. The pt was interrogated and obtained eri=yes. The patient's generator was replaced.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=852242


Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 12, 2011, 09:57:54 AM
Model Number 102
Event Date 04/01/2007
Event Type Injury Patient Outcome Required Intervention;
Event Description
Reporter indicated that "she wondered if the vns is making her worse since she is not responding to the medication as she feels she should and is having more frequent changes made to her medication. " good faith attempts to obtain further info have been made.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=850857



Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 12, 2011, 09:58:34 AM
Model Number 101
Event Date 01/19/2007
Event Type Injury Patient Outcome Required Intervention;
Event Description
Reporter indicated that the patient underwent generator revision surgery due to an increase in seizures. The seizures occurred during the two weeks prior to revision surgery. It is unknown if the increase in seizures was higher than pre-vns baseline. Good faith attempts to obtain more information have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=852221



Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 12, 2011, 09:59:17 AM
Model Number 300-20
Event Date 04/01/2007
Event Type Malfunction Patient Outcome Hospitalization; Required Intervention
Manufacturer Narrative
Device malfunction is suspected.

Event Description
Reporter indicated that while the patient was hospitalized due to seizures, a system diagnostics test was done to rule out an end of service issue. The system diagnostics test resulted in a high lead impedance indicating a possible lead malfunction. Reporter also indicated that vns therapy system has been working well for this patient, stating "this patient was having 100 seizures a day and with vns, they are greatly reduced to hardly any. " further information received indicated that the patient was in a "comatose state" and was transferred to another facility for vns therapy system replacement surgery. X-rays done by treating neurologist, reportedly "did not show any lead issues. " patient underwent vns therapy replacement surgery.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=852418




Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 12, 2011, 09:59:59 AM
Model Number 101
Event Date 04/01/2007
Event Type Injury Patient Outcome Other;
Event Description
Reporter indicated that the patient was to undergo generator revision surgery due to an increase in seizures. It is unknown if the increase in seizures was higher than pre-vns baseline. Good faith attempts to obtain more information have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=854885



Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 12, 2011, 10:00:43 AM
Model Number 101
Event Date 04/30/2007
Event Type Injury Patient Outcome Other;
Event Description
Reporter indicated a patient had experienced a seizure increase above pre-vns baseline levels. The patient was reimplanted with a new generator as an intervention. The reporter stated the generator was at end of service. A battery estimate was performed and yielded approximately 50% of battery life remaining, indicating generator was likely not at end of service. Diagnostics tests performed just prior to generator reimplant surgery indicate the device was performing as intended and was not at end of service. The explanted generator is currently in product analysis.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=855599



Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 12, 2011, 10:01:33 AM
Model Number 101
Event Date 04/30/2007
Event Type Injury Patient Outcome Other;
Event Description
Reporter indicated a patient had experienced a seizure increase above pre-vns baseline levels. The patient was reimplanted with a new generator as an intervention. The reporter stated the generator was at end of service. A battery estimate was performed and yielded approximately 50% of battery life remaining, indicating generator was likely not at end of service. Diagnostics tests performed just prior to generator reimplant surgery indicate the device was performing as intended and was not at end of service. The explanted generator is currently in product analysis.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=855599



Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 12, 2011, 10:02:16 AM
Model Number 101
Event Date 03/01/2007
Event Type Malfunction Patient Outcome Other;
Event Description
Initial reporter indicated that the patient reported that "two months ago, she was told her vns was not working, probably because the battery wasn't working". Reporter also indicated that "since the vns stopped working, the patient's seizures have increased about four times in number". Good faith attempts are being made to obtain additional information.

Manufacturer Narrative
Device malfunction is suspected but did not cause or contribute to a death or serious injury.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=857810



Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 12, 2011, 10:02:52 AM
Model Number 101
Event Date 05/01/2007
Event Type Malfunction
Patient Outcome Other;
Event Description
Reporter indicated that a vns patient had a recent increase in seizure activity. The current seizure rate compared pre-vns baseline is unk. Attempts to obtain additional information from the treating physician have been made and have been unsuccessful to date. A battery life calculation was performed using the programming history available in the in-house database, and it was noted that there is approximately three years of programming history not available. The result of the calculation indicates that there is 14% of the battery capacity remaining and approx 1. 12 years to the end of service indicator is yes. The most recent diagnostics available were performed in 2006, and the results were within normal limits indicating proper device function at that time.

Manufacturer Narrative
Device failure suspected, but did not cause or contribute to death or serious injury.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=858508


Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 12, 2011, 10:04:31 AM
Model Number 101
Event Date 05/01/2007
Event Type Malfunction
Patient Outcome Other;

Event Description
Reporter indicated that a vns patient had a recent increase in seizure activity. The current seizure rate compared pre-vns baseline is unk. Attempts to obtain additional information from the treating physician have been made and have been unsuccessful to date. A battery life calculation was performed using the programming history available in the in-house database, and it was noted that there is approximately three years of programming history not available. The result of the calculation indicates that there is 14% of the battery capacity remaining and approx 1. 12 years to the end of service indicator is yes. The most recent diagnostics available were performed in 2006, and the results were within normal limits indicating proper device function at that time.

Manufacturer Narrative
Device failure suspected, but did not cause or contribute to death or serious injury.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=858508




Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 12, 2011, 10:05:20 AM
Model Number 302-30
Event Date 12/01/2006
Event Type Malfunction Patient Outcome Hospitalization;
Manufacturer Narrative
Only a portion of the lead was returned for analysis which did not reveal any anomalies. Device failure is suspected in the lead portion not returned.

Event Description
Reporter indicated that pt was to have generator revised due to an increase in seizures, above pre-vns baseline. During revision surgery high lead impedance was discovered and the lead was also replaced. The generator and a portion of the lead were evaluated by mfr and no anomalies were found.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=950668



Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 12, 2011, 10:05:53 AM
Model Number 102
Event Date 02/20/2007
Event Type Malfunction
Patient Outcome Other;
Event Description
Reporter indicated that the pt experienced an increase in seizure activity as a result of the generator reaching end of svc. It is unk if increase in seizures is above pre-vns levels. Diagnostic results indicated that generator was at end of svc, other results were not available. Pt had generator replacement surgery.

Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=949100



Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 12, 2011, 10:06:44 AM
Model Number 101
Event Date 10/01/2006
Event Type Injury Patient Outcome Required Intervention; Other
Manufacturer Narrative
X-rays reviewed by the manufacturer, no gross lead discontinuities visualized.

Event Description
Reporter indicated a patient experienced an increase in seizure activity possibly attributed to the vns device. It is unknown if seizure level was above pre-vns levels. Diagnostic testing indicated proper device functionality. The patient continued having voice alteration during stimulation which also suggests that patient was receiving therapy. The patient subsequently had elective generator replacement surgery. No medication or setting changes were attempted prior to surgery to help control seizure activity.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=841868


Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 12, 2011, 10:35:15 AM
Model Number 101
Event Date 12/11/2006
Event Type Injury Patient Outcome Hospitalization;
Event Description
Rptr indicated that pt had generator electively replaced due to an increase in seizures, relationship to pre-vns baseline unk. Prod analysis performed on explanted generator yielded no abnormalities.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=841661



Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 12, 2011, 10:35:45 AM
Model Number 101
Event Date 02/01/2007
Event Type Injury Patient Outcome Hospitalization;
Event Description
Reporter indicated a patient experienced an increase in seizure acitivity above the pre-vns baseline count. The patient was admited to a hospital for monitoring. No recent medication or environmental changes were reported. The cause of the increase in seizure remains unknown at this time. Diagnostic testing run on the device indicated proper device function. However, a rough battery life calculation using programming data provided by the site indicated 0 years remaining, until the device reached end of service. Revision surgery is likely.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=841543



Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 12, 2011, 10:36:23 AM
Model Number 102
Event Date 01/01/2006
Event Type Injury Patient Outcome Other;
Event Description
Patient's mother reported an increase in seizure activity above the pre-vns baseline. She indicated that, the patient's seizure duration has shortened since implant, but said the number of seizures continues to increase monthly. She said the patient has had a marked improvement in mood over the last several months, and the patient is expected to come off all of her anti-depression drugs in the spring. Follow up with the treating physician has been unsuccessful.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=841532



Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 12, 2011, 10:36:54 AM
Model Number 103
Event Date 04/22/2011
Event Type Injury Patient Outcome Other;
Event Description
It was reported in the pt's clinic notes on (b)(6) 2011 that the pt was having an increase in seizure frequency over the previous month. Diagnostic testing on that day showed proper device function. At a later visit on (b)(6) 2011, the physician comments that the frequency had been less over the previous two months, but the ifi indicator was detected on this visit. Likewise, no seizure increase was seen on the pt's (b)(6) 2011 visit, but the device was near end-of-service (eos). A replacement surgery in the future is likely, and attempts for further info have been unsuccessful.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2329465



Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 12, 2011, 10:37:27 AM
Model Number 102
Event Date 11/13/2009
Event Type Injury Patient Outcome Other;
Event Description
It was reported in the pt's clinic notes on (b)(6) 2009 that he was having an increase in seizures. The settings were provided; attempts for further info have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2329460



Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 12, 2011, 10:38:10 AM
Model Number 102
Event Date 02/22/2011
Event Type Injury Patient Outcome Other;
Event Description
It was reported in the pt's clinic notes on (b)(6) 2011 that the pt had a "harder and longer" seizure, during which the pt stopped breathing for 45-50 seconds and became cyanotic. The physician also commented that it was "clear that the staff was able to swipe [the vns] magnet. " the pt's settings and diagnostic info from this date were given, and the device was shown to be properly functioning. Attempts for further info have been unsuccessful.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2329459


Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 12, 2011, 10:38:44 AM
Model Number 300-20
Event Date 03/01/2007
Event Type Malfunction
Manufacturer Narrative
Device malfunction occurred, but did not cause or contribute to a death or serious injury.

Event Description
Reporter indicated that, the pt is experiencing no efficacy, daily seizures and high lead impedance on the normal mode diagnostic test. During clinic visit, system diagnostics resulted in high lead impedance indicating a possible lead malfunction. X-rays received and reviewed by mfr showed a lead break below the positive electrode. Revision surgery is likely. No serious injury was reported.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=962915



Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 12, 2011, 10:39:23 AM
Event Date 06/27/2007
Event Type Malfunction
Event Description
Reporter indicated that a patient presented with a seizure increase, below pre-vns baseline, and device diagnostic testing resulted in high lead impedance. The treating physician was unable to assign an exact cause to the high lead impedance, but trauma and/or patient manipulation may be factors. An x-ray review was performed and no obvious reason for the high lead impedance was found. Revision surgery is likely.
Manufacturer Narrative
X-rays reviewed by the manufacturer, no gross lead discontinuities visualized. H. 6 device failure is suspected, but did not cause or contribute to a death or serious injury.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=886052



Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 12, 2011, 10:43:09 AM
Model Number 101
Event Date 03/01/2007
Event Type Malfunction
Patient Outcome Required Intervention;
Manufacturer Narrative
A device malfunction occurred but did not cause or contribute to a serious injury or death.
Event Description
Reporter indicated that a vns patient was experiencing an increase in seizure level. It was confirmed that increased seizure level had not reached pre-vns baseline. Patient underwent pulse generator replacement surgery. The pulse generator was returned to manufacturer for analysis. Analysis was performed on the returned pulse generator and confirmed that the device had reached end of service. During analysis a leaky q9 transistor was found. A leaky q9 transistor may potentially contribute to pulse generator end of service.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=865065



Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 12, 2011, 10:43:45 AM
Model Number 102
Event Date 01/01/2006
Event Type Injury
Event Description
Reporter indicated that prior to patient undergoing revision surgery there was an increase in seizure activity. Pre-vns seizure rate is unknown. Product analysis performed on explanted generator yielded no anomalies.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=864420



Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 12, 2011, 10:44:22 AM
Model Number 101
Event Date 01/01/2007
Event Type Injury Patient Outcome Other;
Event Description
Reporter indicated that a patient underwent generator replacement surgery due to an increase in seizure activity. The relationship to pre-vns baseline was not reported. Good faith attempts to gain additional information have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=862293



Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 12, 2011, 10:45:20 AM
Model Number 300-20
Event Date 04/01/2007
Event Type Malfunction
Event Description
The reporter indicated that high lead impedance resulted from a systems diagnostics test performed at a routine follow up visit. In addition, a normal mode diagnostic test was performed, which also resulted in high impedance. The patient had experienced an increase in seizure activity, below pre-vns baseline, beginning two weeks prior to the high impedance. No trauma was reported and the physician is unaware of any possible causes for the high impedance. X-rays are under review by the surgeon and are expected to be forwarded to manufacturer for review. Revision surgery is planned.

Manufacturer Narrative
Device failure suspected, but did not cause or contributed to death or serious injury.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=862708



Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 12, 2011, 10:46:04 AM
Event Date 05/01/2007
Event Type Malfunction
Patient Outcome Other;
Event Description
Initial reporter indicated that the pt had presented with increased seizures, relationship to pre-vns baseline unk. Communication was not possible with the pt's generator at that time. The pt underwent generator replacement surgery in 2007.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=861548


Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 12, 2011, 10:46:55 AM
Model Number 102
Event Date 02/01/2007
Event Type Injury Patient Outcome Other;
Event Description
Reporter indicated that pt was not receiving efficacy with vns therapy and had experienced an increase in seizures above pre-vns baseline levels. Diagnostic testing was performed and yielded results within normal limits, indicating proper device function.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=861557



Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 13, 2011, 01:37:16 AM
Model Number 101
Event Date 02/01/2007
Event Type Injury
Patient Outcome Required Intervention;
Event Description
Manufacturer received implant warranty and registration card noting that patient had his vns therapy pulse generator replaced due to end of service. Follow-up with the treating physician revealed that the patient was referred for generator replacement because he was having an increase in seizures above pre-vns baseline. It was further reported that the increase in seizures has since resolved following the generator replacement

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=873093



Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 13, 2011, 01:38:06 AM
Model Number 101
Event Date 01/01/2002
Event Type Injury Patient Outcome Other;
Event Description
Reporter indicated that about six months post-implant in 2001, his device was disabled due to an increase in seizures. Seizure rate prior to vns implantation was about 2-3 seizures a day and post vns implant, he had 6-7 seizures per day. Per the reporter, his device was disabled due to the increase in seizures. No medication changes were made as a result of this reported increase. The vns therapy system remains implanted. Patient's treating physician reported the patient had brain surgeries and the device was disabled in 2005, for that and the patient had increased seizures after the surgery. No additional information has been provided.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=873402


Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 13, 2011, 01:38:44 AM
Model Number 302-20
Event Date 01/01/2007
Event Type Malfunction
Event Description
Reporter indicated that diagnostic tests resulted in high lead impedance during an office visit. The reporter stated that there is no known trauma that may have caused the high lead impedance. It was reported that the pt could not feel stimulation, but it is unknown when this symptom began. F/u with the surgeon indicated that he planned to replace only the generator, and "test the interface of the generator and lead during surgery". He planned to replace the lead only if the high impedance did not resolve with the new generator. Further investigation indicated that both the lead and generator were replaced. The surgeon stated that the pt had an increase in seizures below pre-vns baseline prior to surgery, and that the pt's seizures were better controlled following revision. X-rays were reviewed, and a cause of the high lead impedance could not be conclusively identified. It was noted that the strain relief was not placed according to labeling and two possible sites of lead discontinuity were identified. The explanted products were discarded and will not be returned for analysis.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=871734



Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 13, 2011, 01:39:32 AM
Model Number 302-20
Event Date 01/01/2007
Event Type Malfunction
Event Description
Reporter indicated that high impedance readings were obtained at a pt's office visit. The pt was also experiencing an increase in seizures at that time, but the seizures were not greater than pre-vns baseline levels. The pt underwent a lead revision and a prophylactic battery replacement. Product analysis was completed on the returned complete lead. A stress-induced fracture (fatigue appearance) was noted at the connector ring quadfilar coil near the electrode bifurcation area. This lead break likely contributed to the high impedance condition.

Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=871740




Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 13, 2011, 01:40:12 AM
Model Number 102
Event Date 05/01/2007
Event Type Injury Patient Outcome Hospitalization;
Event Description
Reporter indicated that patient is experiencing a change in seizure intensity. The treating physician reports that the patient had not had a tonic clonic seizure in twenty years. Pt had a seizure during an office visit and was hospitalized. Subsequently, the patient was released from the hospital. No information has been received to date in regards to the treatment the patient received while in the hospital.

Manufacturer Narrative
Device malfunction is suspected but did not cause or contribute to a death of serious injury.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=868972



Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 13, 2011, 01:40:59 AM
Model Number 302-20
Event Date 05/01/2007
Event Type Malfunction
Patient Outcome Other;
Manufacturer Narrative
Device malfunction is suspected but did not cause or contribute to a serious injury or death.
Event Description
Reporter indicated that the pt experienced a seizure that lasted 30 minutes. It was reported that prior to that, the pt had not had any seizures since the vns was programmed on. Subsequently, the pt was seen at an office visit and a system diagnostics test obtained high lead impedance indicating a possible lead malfunction. The pt's device was programmed off. The pt's generator and lead were explanted. Explanted products returned to manufacturer are pending product analysis.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=868592



Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 13, 2011, 01:41:50 AM
Model Number 101
Event Date 09/01/2005
Event Type Injury
Event Description
It was reported at an office visit that the patient was experiencing an increase in seizures. The pre-vns baseline is unknown. The physician prescribed lamictal for seizure control. The patient underwent vns generator replacement surgery about a year and a half after the reported increase seizures event. The replacement surgery was due to generator being at end of service. The generator was returned to manufacturer for analysis and no anomalies were noted. The generator had reached normal end of service.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=866341



Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 13, 2011, 01:42:32 AM
Model Number 302-20
Event Date 01/03/2007
Event Type Malfunction Patient Outcome Other;
Event Description
It was reported that diagnostic tests indicated high lead impedance. It was also reported that the pt experienced an increase in seizure activity above pre-vns baseline, irritability of mood, and sleep disturbance which the physician reported were likely related to the high impedance event. The physician believes that the high impedance may be due to "lead scarring" or "lead fibrosis". No falls or manipulation of the device have been identified. The surgeon did not identify any breaks in the lead during x-ray review. Plans for treatment include increasing medications and vns replacement.

Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=866424



Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 13, 2011, 01:43:06 AM
Model Number 300-20
Event Date 01/01/2006
Event Type Malfunction
Manufacturer Narrative
Review of x-rays by the manufacturer revealed a possible lead discontinuity. Device failure is suspected, but did not cause or contribute to a death or serious injury.

Event Description
Reporter indicated a pt had high impedance readings at an office visit, indicating a possible lead break. The pt was also experiencing an increase in seizures. The seizure increase was not greater than pre-vns baseline levels. Review of x-rays by the manufacturer revealed a suspicious area at the negative electrode that appears to be a break. Revision surgery is planned.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=885326



Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 13, 2011, 01:43:51 AM
Model Number 302-20
Event Date 01/01/2006
Event Type Malfunction
Event Description
It was reported that a vns patient underwent revision surgery where the vns therapy system was replaced due to high lead impedance on a system diagnostics test. During the surgery, the surgeon attempted to repair the lead using derma bond, which was unsuccessful. He then replaced the lead. The generator was replaced prophylactically. Further follow-up with the physician revealed that the patient experienced a breakthrough seizure. It is unknown if seizures are above pre-vns seizure level. The generator and portions of the explanted lead were returned to the manufacturer for evaluation. Product analysis completed on the lead portion returned. The negative helical electrode was not returned for analysis. Derma bond was found on the outer silicone tubing close to the end of the connector boot. The derma bond was removed from the outer silicone tubing and an abraded opening was found on the outer silicone tubing, but the inner silicone tubing was intact and no discontinuities were found. No other anomalies were noted on the analyzed lead portion.

Manufacturer Narrative
Only a portion of the lead was returned for analysis which did not reveal any anomalies. Device failure is suspected in the lead portion not returned, but did not cause or contribute to a death or serious injury.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=883179



Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 13, 2011, 01:44:33 AM
Model Number 300-20
Event Date 06/01/2007
Event Type Malfunction Patient Outcome Other;
Event Description
Initial reporter indicated that the pt has had an increase in seizure activity, is no longer feeling their vns stimulate and has pain in the generator area of the chest when they use their magnet. System diagnostics testing resulted in high lead impedance indicating a possible lead malfunction. X-rays reviewed by manufacturer were inconclusive. Revision surgery is likely. The pt had no known accidents or trauma.

Manufacturer Narrative
X-rays reviewed by manufacturer were inconclusive. Device malfunction is suspected, but did not cause or contribute to a death or serious injury.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=883205




Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 13, 2011, 01:45:35 AM
Model Number 302-20
Event Date 06/01/2007
Event Type Malfunction Patient Outcome Other;
Event Description
Reporter indicated, that pt presented for an office visit with an increase in seizures. Pt's pre-vns baseline seizure rate is unk to mfr at this time. Sys diagnostics and normal mode diagnostics test run during the office visit yielded high lead impedance, indicating a possible lead malfunction. Mfr review of x-rays revealed a lead discontinuity near the second rib in the thoracic region. Good faith attempts to obtain further info are currently being made.

Manufacturer Narrative
Method: pt x-rays assessed by mfr. Results: assessment of x-rays revealed lead discontinuity. Conclusion: device malfunction is suspected.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=881457


Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 13, 2011, 01:46:01 AM
Model Number 302-20
Event Date 06/01/2007
Event Type Malfunction Patient Outcome Other;
Event Description
Reporter indicated that pt presented for an office visit with an increase in seizures. Pt's pre-vns baseline seizure rate is unk to mfr at this time. Sys diagnostics and normal mode diagnostics tests run during the office visit yielded high lead impedance, indicating a possible lead malfunction. Good faith attempts to obtain further info are currently being made.

Manufacturer Narrative
Device malfunction is suspected.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=881458



Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 13, 2011, 01:46:29 AM
Model Number 102
Event Date 06/01/2007
Event Type Malfunction
Event Description
Reporter indicated the pt is planning to have surgery to replace her vns generator because the pt is experiencing an increase in seizures. It is not known if the seizure rate is higher or lower than the pt's seizure rate before being implanted with the vns system. Device diagnostics showed proper device function. A battery life calculation revealed that the generator is. 31 years until eri=yes. No serious injury reported in conjunction with this event.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=881174


Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 13, 2011, 01:47:03 AM
Model Number 300-20
Event Date 01/29/2007
Event Type Malfunction
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.

Event Description
Reporter indicated that diagnostic testing performed on a patient resulted in high lead impedance. The patient also presented with a seizure increase, below pre-vns baseline. A full revision surgery was performed in 2007. The treating medical professional has been unable to determine an exact cause for the high impedance.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=881176



Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 13, 2011, 01:47:33 AM
Model Number 102
Event Date 06/08/2007
Event Type Injury Patient Outcome Other;
Event Description
Reporter indicated that the patient experienced an increase in seizures, relationship to pre-vns baseline unknown, following total knee replacement surgery. Diagnostic testing performed after the onset of the seizure increase indicated proper device function. Good faith attempts to gain additional information have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=875352



Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 14, 2011, 01:23:25 AM
Model Number 300-20
Event Date 06/01/2007
Event Type Malfunction Patient Outcome Other;
Event Description
Initial reporter indicated that the pt has had an increase in seizure activity, is no longer feeling their vns stimulate and has pain in the generator area of the chest when they use their magnet. System diagnostics testing resulted in high lead impedance indicating a possible lead malfunction. X-rays reviewed by manufacturer were inconclusive. Revision surgery is likely. The pt had no known accidents or trauma.

Manufacturer Narrative
X-rays reviewed by manufacturer were inconclusive. Device malfunction is suspected, but did not cause or contribute to a death or serious injury.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=883205




Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 14, 2011, 01:25:24 AM
Model Number 102
Event Date 01/06/2005
Event Type Injury Patient Outcome Required Intervention;
Event Description
Reporter indicated a patient was having increased seizures with a longer postictal state. The pre-vns baseline seizure level is unk. Generator replacement surgery is planned.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=955846


Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 14, 2011, 01:29:31 AM
Model Number 102
Event Date 01/01/2007
Event Type Injury Patient Outcome Other;
Event Description
Reporter indicated that the pt's vns therapy pulse generator was at battery end of the service and that the pt was experiencing an increase in seizures. It is unknown to manufacturer whether or not the increase in seizures is believed by the physician to be related to vns therapy. Additionally, the pt's pre-vns baseline seizure rate is unknown to mfr at this time. Battery replacement surgery is planned for 2007.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=955858


Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 14, 2011, 01:33:14 AM
Model Number 102
Event Date 10/01/2007
Event Type Injury Patient Outcome Other;
Event Description
Reporter indicated that pt was experiencing an increase in seizures following the hyperextension of her neck. Pre-vns baseline seizure rate is unknown to mfr at this time. Good faith attempts for further info are currently being made.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=955863


Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 14, 2011, 01:33:50 AM
Model Number 102
Event Date 01/01/2007
Event Type Injury Patient Outcome Other;
Event Description
Reporter indicated experiencing an increase in seizure activity. The patient has not experienced the sensation in her throat during stimulation. The patient's generator was initially thought to be at end of service. Follow-up with the physician indicated the patient's generator was not at end of service, but instead, the settings had not been adjusted in awhile. The physician said, the patient not perceiving the stimulation was maybe due to becoming acclimated to the device settings. The patient's level of seizure activity prior to being implanted with vns is unk. Good faith attempts to obtain add'l info are being made, but have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=954387



Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 14, 2011, 01:34:28 AM
Model Number 102
Event Date 10/01/2007
Event Type Malfunction
Event Description
Reporter indicated that a vns pt has experienced a seizure increase, relationship to pre-vns baseline unk. Good faith attempts for add'l information have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=954547


Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 14, 2011, 01:36:09 AM
Event Date 10/01/2007
Event Type Injury Patient Outcome Hospitalization;
Event Description
Initial reporter indicated to mfr that they had a vns patient referred to them who had been hospitalized for increased seizures and wanted mfr "to come to their office and check the device. " the patient did not make any appointments at physician's office for follow up. Good faith attempts are being made to ascertain who is now following the patient for their vns treatment.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=950120


Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 14, 2011, 01:37:05 AM
Model Number 101
Event Date 01/01/2007
Event Type Malfunction
Patient Outcome Other;
Event Description
Reporter indicated that the pt's magnet was reported to no longer be working to abort her myoclonic-tonic episodes and the pt is no longer responding to the magnet activation with a cough. The physician indicated that he thinks the pt's generator battery is "weakening. " he states that the pt has had an increase in seizure frequency and overall decline of quality of life over the past 6 months. A system diagnostics test was performed and gave "ok" results. A normal mode test was performed and also gave "ok" results with a dc dc code 4. He indicated that this is not a dramatic increase, but that this finding and the that the pt's clinical situation has diminished over the past 6 months, he thinks the vns "battery is starting to be depleted if not completely depleted. " pt's pre-vns baseline seizure rate is unk to mfr at this time. It was additionally reported that pt is scheduled for a generator replacement because it is believed her generator is nearing end of service. Recent diagnostics were within normal limits.

Manufacturer Narrative
Device malfunction is suspected, but did not cause or contribute to a death or serious injury.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=950479



Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 14, 2011, 01:37:45 AM
Model Number 101
Event Date 10/17/2007
Event Type Malfunction
Event Description
Reporter indicated that a vns pt had experienced four seizures in one day, which the pt believes may have been due to external stress and events. The pt also mentioned that he was concerned that his generator may be nearing end-of-service. A battery life calculation estimated approx. 0. 9 years of battery life remaining. Follow up with the pt's physician revealed that the number of seizures experienced during that one day was above the pt's pre-vns baseline. It was reported that the pt has done well with vns therapy and that he usually experiences an increase in seizures due to stress.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=948712



Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 14, 2011, 01:38:24 AM
Model Number 302-20
Event Date 01/01/2005
Event Type Malfunction
Event Description
Reporter indicated high lead impedance were noted at an office visit. The vns has then programmed off. Analysis of the pt's parameter history noted high lead impedance was first noted in 2005. Reporter indicated the pt has had "slight" increase in seizures. The pre-vns baseline seizure level is unk. The pt underwent a complete revision of his vns system. The explanted products have been requested for return.

Manufacturer Narrative
Device failure is suspected.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=948767



Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 14, 2011, 01:39:27 AM
Model Number 101
Event Date 10/01/2007
Event Type Malfunction
Patient Outcome Required Intervention;
Manufacturer Narrative
Device failure is suspected.

Event Description
Reporter indicated a pt was having an increase in seizures and that it was "unk if the vns was working". The pt underwent a generator replacement four days later; intraoperative diagnostics tests with the new generator were within normal limits. It is unk if the seizure increase is greater than pre-vns baseline seizure levels. The explanted generator is currently in product analysis. Attempts to obtain further information are pending.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=948768



Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 14, 2011, 01:40:01 AM
Model Number 101
Event Date 01/01/2007
Event Type Injury
Manufacturer Narrative
Analysis of programming history performed.

Event Description
Reporter indicated a vns pt had not had good seizure control over the last three years. It is unk if the seizure level is greater that pre-vns baseline levels. A battery estimation performed showed the generator has likely been at end of service for over a year. Further attempts for info from the attending physician are pending.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=939532


Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 14, 2011, 01:40:41 AM
Model Number 101
Event Date 01/01/2007
Event Type Injury Patient Outcome Other;
Event Description
Reporter indicated that a vns patient had been admitted to the hospital for cluster seizures, and while at the hospital it was identified that the patient was experiencing bradycardia. The patient's vns device was turned off at that time; however, the neurologist did not believe the bradycardia was related to vns therapy, and stimulation was turned on again. It is unk if the patient's seizures were above pre-vns baseline.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=939533


Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 14, 2011, 01:41:19 AM
Model Number 300-20
Event Date 01/01/2006
Event Type Malfunction
 Manufacturer Narrative
Only a portion of the lead was returned for analysis which did not reveal any anomalies. Device failure is suspected in the lead portion not returned, but did not cause or contribute to a death or serious injury.

Event Description
Reporter indicated high lead impedance was noted at a routine generator replacement surgery. The pt underwent a complete revision. The pt was also experiencing an increase in seizures, but the increase was not greater that pre-vns baseline seizure levels. The pt had no known trauma. Product analysis was completed on the returned generator and lead. The generator analysis yielded no anomalies and the generator eri flag was set to yes. The lead analysis did not reveal any anomalies. The electrode array was not returned.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=947201




Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 14, 2011, 01:42:01 AM
Model Number 102
Event Date 10/01/2007
Event Type Injury Patient Outcome Required Intervention;
Event Description
Reporter indicated that a vns pt's seizures were worse when stimulation was first initiated after implantation of the vns device. It was reported that the pt's seizures were "longer" and "stronger" than prior to vns stimulation. It was reported that there had been no changes in medication. Follow up with the physician revealed that the pt had developed an infection at the chest incision after implantation of the vns device. The neurologist reported that the change in seizures was due to the infection. The infection was treated with antibiotics. The cause of the infection is unk.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=937309



Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 14, 2011, 01:42:32 AM
Model Number 102R
Event Date 10/02/2007
Event Type Injury Patient Outcome Other;
Event Description
Reporter indicated that a pt experienced an increase in seizures, relationship to pre-vns baseline unk. The pt's generator could not be interrogated in 2007 due to likely eos. A battery life calculation resulted in -38. 08% battery capacity remaining confirming that the generator is at eos. Good faith attempts for additional information have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=937311



Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 14, 2011, 01:43:23 AM
Model Number 101
Event Date 03/01/2007
Event Type Injury Patient Outcome Other;
Event Description
Reporter indicated that a pt is having more seizures now than he did when he was implanted and the pt is not responding as well to magnet activations. The treating physician indicated that the generator was not at eos and increased the pt's epilepsy medications. The pt is being referred for prophylactic generator revision.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=937312



Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 14, 2011, 01:44:00 AM
Model Number 102
Event Date 01/01/2007
Event Type Injury Patient Outcome Other;
Event Description
Reporter indicated that a pt's seizures were increased since having the vns. Follow up with the physician's office revealed the reporter did not state, there was a seizure increase at a recent office visit. Attempts for further information from the physician are in progress.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=937313


Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 14, 2011, 01:44:46 AM
Model Number 102R
Event Date 10/24/2006
Event Type Malfunction
Event Description
Reporter indicated that a vns pt has not experienced good seizure control since the pt"s third vns generator, the patient's seizures were well controlled; however, after the most recent generator replacement the doctor reported that the patient lost seizure control and his seizures have not improved. It was reported that device diagnostic tests were ok

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=937576

.


Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 14, 2011, 01:45:34 AM
Model Number 101
Event Date 07/01/2007
Event Type Injury Patient Outcome Other;
Event Description
Reporter indicated a patient was experiencing increased seizures greater than pre-vns baseline levels. The reporter believes that vns is related to the seizure increase and a generator replacement is planned. Diagnostics tests are within normal limits and the generator is not at end of service. A surgery consult is pending.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=937398



Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 14, 2011, 01:46:20 AM
Model Number 101
Event Date 08/01/2005
Event Type Injury Patient Outcome Other;
Event Description
It was reported to mfr that the generator was at end of service and there was an increase in seizure activity, pre-vns baseline unk. Further follow up with the surgeon revealed that the patient was referred for generator replacement surgery due to reported end of service. In addition to the increase in seizure activity, it was reported that the patient was no longer sensing the magnet mode stimulation upon swiping the magnet. Pre-operative diagnostics revealed normal device function and the eri flag was no. X-rays were reviewed by the surgeon and no anomalies were observed and the lead appeared to be intact. During surgery, the generator was replaced and the chest pocket was revised due to the patient being thin. The surgeon opted to remove the existing lead and replace it with a new lead. The reason the existing lead was removed was not clearly communicated, as there did not appear to be any problems with the lead. After the new generator was connected to the new lead, the device was checked and revealed normal device function. Further follow up with the explanting facility revealed that the explanted products was discarded two weeks following the surgery, and therefore will not be returned for analysis. Attempts to obtain add'l information from the referring physician have been made, but have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=937400


Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 14, 2011, 01:47:00 AM
Event Date 10/01/2007
Event Type Injury
Patient Outcome Other;
Event Description
Reporter indicated that a vns pt had experienced an increase in seizures above pre-vns baseline level. The physician requested recommendations on which vns setting could be changed in order to improve seizure control. It was reported that there had been no trauma or manipulation of the device. It was reported that it was possible that the pt had changes in medication or worsening disease process. Attempts to gather additional information have been unsuccessful to date as the pt has been referred to another clinic, but has not yet had an office visit there.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=934770



Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 14, 2011, 07:03:44 AM
Event Date 01/01/2007
Event Type Malfunction
Event Description
Reporter indicated that a pt experienced an increase in seizure frequency with vns therapy. Vns treatment was stopped after six mos.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=970690




Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 14, 2011, 07:04:17 AM
Event Date 01/01/2007
Event Type Malfunction
Event Description
Reporter indicated that a pt did not experience a reduction in seizure frequency with vns therapy.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=970693



Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 14, 2011, 07:04:55 AM
Model Number 100
Event Date 07/01/2007
Event Type Injury Patient Outcome Other;
Event Description
Reporter indicated that a vns patient had experienced an increase in seizures, with "multiple seizures" in the previous four months. The number of seizures relative to pre-vns baseline is unknown. It was reported that the generator had reached end-of-service and that "interrogation indicates low battery. " surgery is likely.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=969857



Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 14, 2011, 07:05:30 AM
Model Number 102
Event Date 11/01/2007
Event Type Injury Patient Outcome Hospitalization;
Event Description
Reporter indicated that patient had multiple seizures post-implant and had to be admitted to the hospital. Good faith attempts to obtain further info, including the patient's pre-vns baseline seizure rate, are currently being made.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=967997



Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 14, 2011, 07:06:05 AM
Model Number 300-20
Event Date 11/01/2007
Event Type Malfunction Patient Outcome Hospitalization;
Manufacturer Narrative
Device malfunction is suspected, but did not cause a death.

Event Description
Reporter indicated the pt presented with high lead impedance on a systen diagnostic test. The pt was admitted to the hosp due to a status epilepticus. The pt's parents report the pt has recently "been having seizures and while having seizures the pt would fall. " the pt's seizure level before being implanted with the vns is unk. The pt is not feeling normal stimulation. The pt was last seen by the treating physician in 2005. A battery life calculation revealed the generator is 4. 39 years until the elective replacement indicator will read yes. Good faith attemtps to obtain additional info are being made, but have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=968513




Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 14, 2011, 07:06:54 AM
Model Number 102
Event Date 11/29/2007
Event Type Injury Patient Outcome Other;
Event Description
Initial reporter indicated the patient was having an increase in seizures and that medication changes were helping the patient's increase in seizures. It is unknown if the increase in seizures reported was over the patient's pre-vns implantation rate. The patient is scheduled for prophylactic generator replacement. Good faith attempts are being made to obtain additional information.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=967311



Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 14, 2011, 07:07:43 AM
Model Number 102
Event Date 11/01/2007
Event Type Injury Patient Outcome Other;
Event Description
It was reported to manufacturer that the vns patient was experiencing a change in seizure pattern. The patient's caregiver stated that "previously (the patient) would have small seizures that would last a total of 11 minutes and if the magnet was swiped in time it would shorten the seizure and the post ictal period, but the last few small seizures have lasted a total of 15 minutes and when the magnet is swiped there seems to be no change in the seizure". The seizure rate compared to pre-vns baseline is unk. Attempts to obtain add'l information from the treating physician have been made, but have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=966628


Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 14, 2011, 07:08:33 AM
Model Number 101
Event Date 01/01/2007
Event Type Injury Patient Outcome Required Intervention;
Event Description
Reporter indicated that, a vns patient no longer felt stimulation and had experienced an increase in seizures for approx one month. It was reported that the patient had no seizures with a vns therapy and then recently began having approx three seizures per day. The patient's pre-vns baseline is unk. It was initially reported that the physician believed the patient's generator had most likely reached end-of-service. It was then reported that the patient followed up another physician who increased the vns settings and the patient's seizures were more controlled after this change. It was reported that the physician stated that, the patient's generator had "about a year left" and did not want to replace the generator yet.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=966653



Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 14, 2011, 07:09:15 AM
Model Number 100B
Event Date 07/17/2002
Event Type Injury Patient Outcome Other;
Event Description
Reporter indicated a pt had increased seizures prior to vns generator replacement, but that the pt was not a reliable historian regarding the seizure level. The reporter also stated the pt was not feeling stimulation prior to the generator replacement, but felt it after the surgery. A battery estimate performed demonstrated the generator was very likely at end of service. The explanted generator was discarded by the hospital.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=964261



Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 14, 2011, 07:11:15 AM
Model Number 102R
Event Date 09/17/2007
Event Type Injury Patient Outcome Other;
Event Description
Reporter indicated a pt was experiencing poor seizure control prior to a recent prophylactic vns generator replacement. The generator is currently in product analysis. Reporter indicated the pt is not a good historian regarding his seizure level, and that he was not feeling stimulation prior to surgery, but felt it afterwards. The reporter felt the vns may have been nearing end of service and wanted the generator replaced prophylactically. Further requests for info are in progress.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=964262



Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 14, 2011, 07:11:56 AM
Event Date 11/15/2007
Event Type Injury Patient Outcome Required Intervention;
Event Description
Reporter initially indicated that a vns patient experienced seizures, below pre-vns baseline. It was reported that the patient was in the "titration" phase of vns therapy, and the physician believed the seizures occurred because the "patient developed additional resistance to medications. " the site did not have a programming system for several months, and therefore vns settings could not be adjusted. It was then reported that "recently the patient has been rapidly increasing seizures. They are very concerned because it is getting worse and worse. " it is unknown if the patient's seizures are above baseline at the time of this later report. Attempts to obtain additional information have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=964283



Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 14, 2011, 07:12:33 AM
Model Number 102
Event Date 01/01/2007
Event Type Malfunction
Event Description
Reporter indicated a vns pt had a more severe episode of status epilepticus than pre-vns baseline levels. The increase in the seizure level is believed to be due to the vns being at zero output for a peirod of several weeks following a believed programming anomaly event. A flashcard download for data analysis has been requested.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=964474



Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 14, 2011, 07:14:03 AM
Model Number 302-30
Event Date 01/01/2007
Event Type Malfunction
Manufacturer Narrative
Method- manufacturer reviewed x-rays of implanted device. Results- x-rays reviewed by the manufacturer, no gross lead discontinuities visualized. Conclusions- device failure is suspected, but did not cause or contributed to a death or serious injury.

Event Description
Reporter indicated that a vns pt experienced an increase in seizures, and seizure level relative to pre-vns baseline is unk. Follow-up with the site revealed that diagnostic tests showed high lead impedance. It was reported that the pt had fallen recently during a seizure, although it has not been reported if this is a believed cause of the high lead impedance. X-rays were reviewed by the manufacturer and a cause of the high lead impedance was not identified in the x-rays received. Revision surgery is likely.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=963375



Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 14, 2011, 07:15:01 AM
Model Number 102
Event Date 11/12/2007
Event Type Injury Patient Outcome Required Intervention;
Event Description
Reporter indicated a vns pt was unable to be interrogated and was having increased seizures requiring hospital admission. A battery calculation for the generator revealed likely end of service with -0. 37 years remaining. Further attempts for info are in progress.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=962555



Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 14, 2011, 07:15:54 AM
Model Number 102
Event Date 11/10/2007
Event Type Injury Patient Outcome Hospitalization;
Event Description
Reporter indicated that vns therapy patient came to the emergency room due to an increase in seizures. Pre-vns baseline seizure rate is unknown to manufacturer at this time. Good faith attempts for further information are currently being made

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=960048



Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 14, 2011, 07:17:34 AM
Model Number 300-30
Event Date 11/01/2007
Event Type Malfunction
Event Description
Reporter indicated that a vns pt has experienced an increase in seizures following a four-wheeler accident, during which the pt collided with a trampoline.

Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=960125



Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 14, 2011, 07:18:23 AM
Model Number 102
Event Date 11/01/2007
Event Type Malfunction
Patient Outcome Other;
Manufacturer Narrative
Device malfunction is suspected, but did not cause or contribute to a death.

Event Description
Initial reporter indicated that the vns patient was having "increased seizures. " it is unknown if the increase in seizures is above or below pre-vns baseline. Good faith attempts are being made to attain further details about the event.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=960157



Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 14, 2011, 07:19:37 AM
Model Number 300-20
Event Date 10/22/2007
Event Type Malfunction Patient Outcome Other;
Manufacturer Narrative
Only a portion of the lead was returned for analysis which did not reveal any anomalies. Device failure is suspected in the lead portion not returned, but did not cause or contribute to death.

Event Description
It was reported to manufacturer that the vns patient was not sensing normal stimulation of the device and it was believed to be due to normal battery depletion. The physician performed both normal and system diagnostic tests and after both tests the following message appeared: "programmed current possibly not being delivered". The physician did not move on to the results screen to view the entire test results and did not visualize that there was high lead impedance. The patient was referred for generator replacement surgery where it was revealed during intraoperative troubleshooting that the lead was problematic. The lead was subsequently explanted and a new device was re-implanted. The lead and generator were returned to manufacturer for analysis. The portion of the lead returned revealed no anomalies during the analysis. The explanted generator is pending the completion of the analysis, however, the analysis findings are not expected to reveal that the generator contributed to the reported event. Further follow up with the treating physician revealed that the patient also had an increase in seizure activity, relationship to pre-vns baseline not unknown, beginning about one month prior to surgery. Xrays are not available to review.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=960164



Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 14, 2011, 07:20:28 AM
Model Number 300-20
Event Date 11/01/2007
Event Type Malfunction Patient Outcome Other;
Manufacturer Narrative
Device malfunction is suspected.

Event Description
Reporter indicated that pt presented to office visit with an increase in seizures. Pre-vns baseline seizure rate is unk to manufacturer at this time. System diagnostic testing performed at this office visit yielded high lead impedance, indicating a possible lead malfunction. Good faith attempts to obtain further info are currently being made.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=960235



Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 14, 2011, 07:21:24 AM
Model Number 102
Event Date 10/01/2007
Event Type Injury Patient Outcome Other;
Event Description
Reporter indicated that a vns patient experienced a seizure increase, below pre-vns baseline. The patient's seizures have increased from the previous level of the past few months. The treating medical professional indicated that there are no external factors for which the change can be attributed. The patient is also reported to not respond to magnet activations as she had in the past. Parameters are to be increased in an attempt to achieve better efficacy and the patient has an appointment with the surgeon for generator revision surgery.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=959368


Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 14, 2011, 07:22:21 AM
Model Number 102
Event Date 01/01/2007
Event Type Injury Patient Outcome Other;
Event Description
Reporter indicated that patient was experiencing an increase in seizures above pre-vns baseline, longer seizures, and more intense seizures. Different parameters were tried, and device was even turned off for a period of time, but increase above baseline remained. Patient's topomax medication was also increased in attempt to decrease seizure rate. Patient's device was subsequently turned back on when it was observed that the increase in seizures remained despite device disablement. Physician additionally indicated that he did not believe the increase was related to vns therapy

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=959371


Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 14, 2011, 07:23:15 AM
Model Number 102
Event Date 01/01/2007
Event Type Injury Patient Outcome Other;
Event Description
Reporter indicated that patient was experiencing an increase in seizures above pre-vns baseline, longer seizures, and more intense seizures. Different parameters were tried, and device was even turned off for a period of time, but increase above baseline remained. Patient's topomax medication was also increased in attempt to decrease seizure rate. Patient's device was subsequently turned back on when it was observed that the increase in seizures remained despite device disablement. Physician additionally indicated that he did not believe the increase was related to vns therapy

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=959371


Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 14, 2011, 07:24:51 AM
Model Number 302-20
Event Date 01/01/2007
Event Type Malfunction
Event Description
Initial reporter indicated the pt was having worsening seizure activity over the last 6-9 months. The seizures reported were at the pt's preimplantation seizure rate. The device was interrogated and high lead impedance was discovered indicating a possible lead malfunction. X-rays were reviewed by the pt's treating physician "who thought there may be an indication of one of the coils come off the vagus nerve. " the pt had not been seen in the clinic for at least 15 months, there was no report of any falls as the child cannot walk and is in a chair continuously. It was additionally reported "he has grown a great deal since implantation. " the pt underwent full revision surgery. Cyberonics is pending receipt of the explanted products for analysis. It was reported the "surgeon could not see exactly where the problem had occurred but thought the 'loop' had disappeared. ".

Manufacturer Narrative
Device malfunction suspected but did not cause or contribute to a death.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=959506



Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 14, 2011, 07:25:48 AM
Model Number 102
Event Date 11/01/2007
Event Type Malfunction Patient Outcome Other;
Event Description
It was reported the pt was unable to feel normal and magnet stimulation. All diagnostics were reported to be "ok". It was additionally reported the pt was having an increase in seizures. Good faith attempts are being made for additional info surrounding the reported events.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=959507


Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 14, 2011, 07:26:39 AM
Model Number 103
Event Date 11/02/2007
Event Type Malfunction Patient Outcome Other;
Manufacturer Narrative
Device malfunction is suspected, but did not cause a death.

Event Description
Initial reporter indicated that the pt "was having an increase in seizures that were worse than before vns. " the pt's mother believed the event was related to the pt being constipated. Good faith attempts are being made for additional info from the treating physician.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=959508


Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 14, 2011, 07:27:48 AM
Model Number 102
Event Date 08/06/2007
Event Type Death Patient Outcome Death; Hospitalization
Event Description
Reporter indicated that a vns patient experienced choking, gagging, and vomiting with stimulation, which led to the patient being admitted to a hospital due to dehydration. The reporter also indicated that the patient's seizures worsened with the stimulation. The patient then reportedly died a few weeks later due to respiratory failure. Previous correspondence with the treating neurologist revealed that the patient died of liver failure and death certificates states that the patient died due to respiratory failure, liver disease, and intractable seizures. The explanted generator and a portion of the lead were received from the funeral home. No anomalies were found with the generator as it performed according to specifications. The returned portion of the lead performed according to specifications. Good faith attempts for additional information have been successful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=957507


Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 14, 2011, 07:28:56 AM
Model Number 102
Event Date 01/01/2007
Event Type Injury Patient Outcome Required Intervention;
Event Description
Reporter indicated that a pt would have the vns generator and lead explanted. It was reported that the vns device "had stopped being beneficial" and the pt wanted to have the device removed due to discomfort caused by the generator in the pectoral region. It was reported that the "vagal nerve stimulator didn't seem to reduce her seizure disorder. " at an earlier date while receiving vns therapy, the physician's notes stated that the pt's epilepsy worsened and that most of the pt's seizures were of a "convulsive" type with as many as 5 to 10 seizures per month

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=958445



Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 14, 2011, 09:28:19 AM
Model Number 102
Event Date 07/01/2007
Type Injury Patient Outcome Other;
Event Description
Reporter indicated that the patient was experiencing an increase in seizures above pre-vns baseline, and more intense seizures. It was reported that the increase in seizures was seen after the patient started school. The physician stated that he had ramped the patient's device settings up at a faster rate than he typically does for other patients. Further follow up with the physician revealed that the seizures may be related to stress since the patient recently started college, however the relationship to vns therapy was still not known. Additionally, it was reported that device diagnostics performed following the onset of the increase in seizures indicate normal device function. The physician additionally indicated that the device settings will be decreased and the medication will also be adjusted to help with the seizures.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=989686



Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 14, 2011, 09:28:59 AM
Model Number 302-20
Event Date 12/26/2007
Event Type Malfunction Patient Outcome Other;
Event Description
It was reported to manufacturer that the patient's device revealed high lead impedance when tested at a follow up visit. As a result, the physician referred the patient for surgery. During surgery, both normal and system diagnostics testing revealed high impedance with eri = no, indicating a discontinuity in the system. The surgeon opted to explant the lead and the generator and no new devices were implanted at that time. Further follow up with the neurologist's office revealed that the patient experienced an increase in seizure activity and relationship to pre-vns baseline is unknown. The physician's office communicated that it's possible that patient's weight gain could have contributed to the high lead impedance diagnostic test result. There was no other trauma or manipulation reported to the manufacturer. Good faith attempts are being made to obtain additional information from the treating physician. Additionally, good faith attempts are being made to obtain the explanted products for analysis.

Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=984137


Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 14, 2011, 09:29:48 AM
Model Number 102
Event Date 12/01/2007
Event Type Malfunction Patient Outcome Other;
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.

Event Description
Initial reporter indicated that the pt's generator was not able to be interrogated. The last successful interrogation of the device was in 2006. All values were normal at that time. The handheld/wand was able to interrogate other pts, so the handheld/wand is working effectively. Reporter also indicated that the pt is experiencing increased seizures, pre-vns baseline unknown. Good faith attempts are being made to obtain the programming history.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=984151


Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 14, 2011, 09:30:25 AM
Model Number 102
Event Date 09/01/2007
Event Type Injury Patient Outcome Required Intervention;
Event Description
Reporter indicated that a vns pt had experienced coughing, shortness of breath, and pain in the area of the electrodes on the left side of his neck. It was reported that the output current had been adjusted in an attempt to alleviate the events. It was reported that the pt wanted to have the vns device explanted. F/u with the treating physician revealed that the pt thought that the events were related to vns stimulation and that the "vns caused seizures", and the vns output current was then set to 0ma. The surgeon reported that the vns generator and leads were explanted due to pain and an increase in seizures, as the pt had experienced "more seizures than ever before". It was reported that the pt had at one time achieved good efficacy and seizure reduction after beginning vns therapy.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=983383



Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 14, 2011, 09:31:06 AM
Model Number 302-20
Event Date 12/14/2007
Event Type Malfunction
Manufacturer Narrative
Mfr reviewed x-rays of implanted device. Review of x-rays by the mfr revealed a gross lead discontinuity. Device failure occurred, but did not cause or contribute to a death or serious injury.

Event Description
Reporter indicated that diagnostic testing resulted in high lead impedance. It was reported that about the same time the pt experienced a reemergence of daytime seizures and did not perceive stimulation. Relationship of current seizures to prevns baseline is unk. X-rays were sent to the mfr, and a lead fracture was observed. Lead revision surgery is likely. Good faith attempts to obtain additional info have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=983644



Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 14, 2011, 09:31:45 AM
Model Number 101
Event Date 12/27/2007
Event Type Malfunction
Event Description
Initial reporter indicated that they had been having an increase in seizures. It is unknown at this time if the increase in seizures is above the patient's pre vns implantation seizure rate. Good faith attempts are being made for more information surrounding the seizure event.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=983477


Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 14, 2011, 09:32:22 AM
Model Number 102
Event Date 12/20/2007
Event Type Injury Patient Outcome Other;
Event Description
Reporter indicated experiencing an increase in seizure activity. The pt's seizure activity level prior to vns therapy implant is unk. Good faith attempts to obtain add'l info are being made, but have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=981612



Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 14, 2011, 09:32:51 AM
Model Number 101
Event Date 12/01/2007
Event Type Injury Patient Outcome Other;
Event Description
Reporter indicated the patient was experiencing an "increasing frequency and severity of seizures, and inability of the magnet to reliably abort the seizures. " the patient's seizure frequency and severity levels prior to initial vns therapy implant are unknown. A battery life calculation revealed the generator was. 39 years until the elective replacement indicator = yes, which indicates the generator was most likely at end of service. The patient underwent generator replacement surgery. The generator has been returned to the manufacturer and is pending product analysis. Good faith attempts to obtain additional information are being made, but have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=981613


Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 14, 2011, 09:33:28 AM
Model Number 102
Event Date 12/01/2007
Event Type Injury Patient Outcome Hospitalization; Other
Event Description
Reporter indicated that after starting vns therapy he had a seizure that was "the worst he ever had that he can remember. " he reported he was hospitalized for three days and his medication has been increased. Pt later reported he thought his "vns was great. " good faith attempts for further info are currently being made.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=981629


Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 14, 2011, 09:35:58 AM
Model Number 302-20
Event Date 12/01/2007
Event Type Malfunction Patient Outcome Other;
 Manufacturer Narrative
Device malfunction is suspected.
Event Description
Reporter indicated that pt presented for routine office visit where diagnostic testing revealed high lead impedance, indicating a possible lead malfunction. Pt subsequently reported that she could no longer detect normal or magnet mode stimulation, and that she was experiencing an increase in seizures above pre-vns baseline. Physician indicated that pt was no longer taking any medications as she had prior to vns therapy. Pt subsequently underwent a full revision procedure. Explanted lead and generator were returned to mfr for product analysis, however, that analysis is not yet completed.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=982402



Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 14, 2011, 09:36:52 AM
Model Number 300-20
Event Date 10/16/2997
Event Type Malfunction Patient Outcome Other;
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.

Event Description
Reporter indicated that a vns patient experienced "an increase in epileptic fits. " diagnostic testing then resulted in high lead impedance. The pt underwent generator and lead revision surgery to correct the high impedance. The explanted generator has been rec'd and is awaiting analysis. Good faith attempts for additional info and return of the explanted lead have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=982404



Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 14, 2011, 06:33:21 PM
Model Number 102
Event Date 01/01/2007
Event Type Injury Patient Outcome Other;
Event Description
Reporter stated she was experiencing an increase in seizures that is greater than pre-vns baseline levels and that the seizures are lasting longer. Attempts for further info from the attending physician are in progress.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=980892



Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 14, 2011, 06:34:00 PM
Model Number 302-20
 Event Date 09/01/2007
Event Type Malfunction
Patient Outcome Other;
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.

Event Description
Reporter indicated that diagnostic testing resulted in high lead impedance during an office visit in late 2007. It was reported that the pt experienced an increase in seizures beginning in approx three months earlier with unk relationship to pre-vns baseline. The radiologist took x-rays of the neck and chest without any noticeable fractures. Physician is planning to have x-rays forwarded to mfr for review. Lead revision surgery is planned.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=981027



Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 14, 2011, 06:34:53 PM
Model Number 101
Event Date 12/01/2007
Event Type Malfunction
Event Description
Reporter indicated that a vns pt was "having unexplained increase in seizures. " the seizure level relative to pre-vns baseline was not reported. A battery life calculation with available programming history estimated 4. 2 years remaining until eri - yes. Diagnostics were reported to be within normal limits.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=981043



Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 14, 2011, 06:35:28 PM
Model Number 102
Event Date 04/01/2006
Event Type Injury Patient Outcome Hospitalization;
Event Description
The rptr indicated that the pt mother left a message on their voicemail. "the problems referenced were increasing seizures, a feeling like the wires are pulling, choking every-time the magnet is used on the generator. The pt has been to the er, several times. The er sent her home, saying she has muscle spasms. The pt has been crying" it was reported that the pt was not able to find someone to perform ct scan or x-rays. The pt's mother wanted the vns sys removed from the pt. The pt underwent a full revision surgery. Good faith attempts for add'l info are in progress and awaiting response.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=997863


Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 14, 2011, 06:36:27 PM
Model Number 302-20
Event Date 12/01/2007
Event Type Malfunction
Patient Outcome Other;
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.

Event Description
Reporter indicated that the patient's vns device was "not working". It was reported that the patient was having seizures and that when the magnet was swiped over the device, the vns did "not detect" the magnet swipe. Follow up with the physician revealed that the patient could no longer feel vns stimulation and that the patient's seizures had increased to pre-vns baseline or "maybe a little worse". It was reported that the patient has frequent falls from seizures. It was also reported that the physician felt the generator moves around inside the chest pocket. A system diagnostic test was then performed, and the test indicated high lead impedance. It was reported that the patient was recently hospitalized due to "cardiac and/or respiratory failure" and the patient" was released with code blue". The relationship to vns is unknown at this time. Revision surgery is likely.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=977680



Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 14, 2011, 06:37:05 PM
Model Number 302-20
Event Date 12/01/2007
Event Type Malfunction Patient Outcome Hospitalization;
Manufacturer Narrative
Device failure is suspected.

Event Description
Reporter indicated that a vns pt experienced severe seizures that required hospitalization. Diagnostic testing revealed that the pt had high lead impedance. The pt is currently being considered for brain resection surgery, and if that does not occur, then revision surgery is likely. Good faith attempts for add'l info have been unsuccessful to date.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=972122


Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 14, 2011, 06:38:09 PM
Model Number 102
Event Date 12/14/2007
Event Type Malfunction
 Event Description
Initial reporter indicated the patient was having an increase in seizures over their pre vns seizure rate. The treating physician felt the event was related to the vns generator nearing end of battery life. The patient will be scheduled to have their vns battery replaced. All diagnostic testing on the vns device reported to be within normal limits.

Manufacturer Narrative
Although a serious injury did occur, no malfunction is suspected

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=977763



Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 14, 2011, 06:39:23 PM
Model Number 300-20
Event Date 01/01/2007
Event Type Malfunction Patient Outcome Other;
 
Manufacturer Narrative
Device failure suspected, but did not cause or contribute to a death or serious injury.

Event Description
Reporter indicated that a system diagnostic test indicated high lead impedance. It was reported that the patient's seizures had increased and were above pre-vns baseline. Revision surgery is likely.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=977138


Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 14, 2011, 06:40:11 PM
Model Number 102
Event Date 12/01/2007
Event Type Injury Patient Outcome Other;
Event Description
Reporter indicated that a vns patient experienced a seizure increase, relationship to pre-vns baseline unknown. The patient's off time was decreased from 5 minutes to 3 minutes to mitigate the seizures. All diagnostic testing results were within normal limits. Good faith attempts for additional information have been unsuccessful to date

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=974622



Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 14, 2011, 06:41:12 PM
Model Number 302-20
Event Date 12/01/2007
Event Type Malfunction Patient Outcome Other;
Event Description
Initial reporter indicated that the patient had not been seen for over a year. It was reported that the patient had an increase in seizures in last six months or more. No pain with stimulation reported in neck area. Diagnostics were performed that showed high lead impedance indicating a possible lead malfunction. Patient x-rays reviewed by physician "showed possible problem with electrodes, pin seemed in place. Opinion of surgeon, is child has grown a lot and he is considering what he could do to address the problem reloops in the neck". The patient may be scheduled for lead revision.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=973217


Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 16, 2011, 09:58:28 AM
Model Number 102
Event Date 02/01/2008
Event Type Injury Patient Outcome Other;
Event Description
Reporter indicated the pt was experiencing an increase in seizures. It is not known if the increase is above or below pre-vns therapy baseline. Generator had reportedly reached end of service and was replaced. Good faith attempts were made with the treating physician to obtain further info; however, these attempts went unanswered. Most likely cause of the increase in seizures was due to loss of therapy since generator had reached end of service.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1021318



Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 16, 2011, 09:59:03 AM
Model Number 101
Event Date 02/27/2008
Event Type Injury Patient Outcome Other;
Event Description
Reporter indicated that the pt was experiencing an increase in seizures. It is unk at this time whether the seizures were above, below or at pre-vns baseline. Good faith attempts are being done to obtain additional info.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1021320



Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 16, 2011, 09:59:40 AM
Model Number 102
Event Date 02/01/2008
Event Type Injury Patient Outcome Other;
Event Description
Reporter indicated that a vns pt has experienced a seizure increase, relationship to pre-vns baseline unk, and is concerned that his generator is approaching end of service. Good faith attempts for additional info have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1021321


Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 16, 2011, 10:00:58 AM
Model Number 101
Event Date 02/19/2008
Event Type Malfunction Patient Outcome Other;

Event Description
The reporter indicated the pt has experienced an increase in seizures. The reporter feels it is appropriate timing for a vns battery change. The reporter plans to send the pt for a surgery consult. Good faith attempts for additional info are in progress and awaiting results.

Manufacturer Narrative
Device malfunction is suspected, but did not cause or contribute to a death.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1018174



Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 16, 2011, 10:01:50 AM
Model Number 102
Event Date 01/17/2008
Event Type Malfunction
Patient Outcome Other;
Manufacturer Narrative
Device malfunction is suspected, but did not cause or contribute to a death.

Event Description
The reporter indicated the patient's generator was not functioning properly due to suspected battery depletion. In addition, the patient experienced an increase in seizures above pre-vns baseline. The reporter surgically replaced the patient's generator. The manufacturer has received the generator for product analysis. (pending results) good faith attempts for additional information are in progress and awaiting results.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1018181



Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 16, 2011, 10:02:36 AM
Model Number 101
Event Date 11/28/2007
Event Type Injury Patient Outcome Other;
Event Description
Reporter indicated a vns patient present with "increase seizure frequency and has the clinical perception that the device was not activating as strongly as in the past. The pt's seizure activity level is higher than it was prior to being implanted with the vns therapy system. The "seizures are somewhat more intense in many respects than they have been for a number of years. " the treating physician "felt that there was not much electrical evidence for device failure. " the pt has a history of tracheomalacia and tracheal surgery; therefore, the pt was referred to the ent. The ent indicated that pt's "right vocal cord function is normal. The left vocal cord function at baseline is abnormal and reduced, but with stimulation from the device, there is visible motion of the vocal cord consistent with the electrical input to the vagus nerve from the device. " the physician suspects the vns therapy system may be "nearing end of service life. " good faith attempts to obtain additional info have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1015571


Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 16, 2011, 10:03:21 AM
Model Number 300-20
Event Date 10/12/2007
Event Type Malfunction Patient Outcome Other;
Event Description
It was reported that diagnostic testing resulted in high lead impedance. Additionally, the patient experienced an increase in seizures, relationship to pre-vns baseline unknown. Generator and lead revision surgery were performed. The explanted product has been returned to the manufacturer for analysis. Good faith attempts for additional information have been unsuccessful to date.

Manufacturer Narrative
Device failure is suspected.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1017630



Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 16, 2011, 10:04:24 AM
Model Number 102
Event Date 01/01/2008
Event Type Malfunction
Manufacturer Narrative
Device malfunction is suspected, but did not cause or contribute to a death or serious injury.

Event Description
Reporter indicated that she was experiencing an increase in seizures "worse than before she got implanted with vns. " pt's pre-vns baseline seizure rate is unk to mfr at this time. Pt also stated she thinks her pulse generator "turned itself off. " treating physician was subsequently unable to interrogate pt's generator. Good faith attempts to obtain further info are currently being made

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1018346



Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 16, 2011, 10:05:02 AM
Event Date 02/11/2008
Event Type Malfunction
Manufacturer Narrative
Device malfunction is suspected, but did not cause or contribute to a death or serious injury.

Event Description
The reporter indicated the pt has experienced an increase in seizures. The reporter suspects "it might be related to decreased battery life of the vns. " the reporter plans to perform battery replacement. Good faith attempts for add'l info are in progress and awaiting results.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1018347


Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 16, 2011, 10:06:17 AM
Model Number 101
Event Date 02/01/2008
Event Type Injury Patient Outcome Other;
Event Description
Initial reporter indicated that the "vns was turned off for an increase in seizures. " the patient reported her seizures were above her pre vns implantation rate. Good faith attempts have been made for additional information surrounding the event.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1012690



Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 16, 2011, 10:07:28 AM
Model Number 102
Event Date 01/08/2008
Event Type Injury Patient Outcome Other;
Event Description
Reporter indicated that a vns patient experienced respiratory issues and a seizure increase, relationship to pre-vns baseline unk. The reporter wrote that "his lung sounds are course and wet, and we're giving him nebulizer treatments every four hours. He's not sleeping much and is having more seizures. A chest x-ray showed possible pneumonia in his left lung, so we're treating it as pneumonia with antibiotics, steroids, and continued nebulizer treatments. " the reporter indicated that the patient recovered from his illness in 2007. Good faith attempts for additional information have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1009078


Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 16, 2011, 10:08:15 AM
Model Number 101
Event Date 01/29/2008
Event Type Injury Patient Outcome Other;
Event Description
Patient's implant card was rec'd by the mfr. It was indicated on the form that the vns device has been replaced due to end of service. Additionally, it was reported that the pt was experiencing an increase in seizures. Good faith attempts are being made to obtain additional info.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1009741


Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 16, 2011, 10:10:15 AM
Event Date 02/09/2000
Event Type Injury Patient Outcome Hospitalization; Required Intervention
Event Description
Rptr indicated that a pt's vns generator had reached end-of-svc and that the pt was in the hosp due to increased seizures, with pre-vns baseline unk. The pt then underwent generator replacement surgery. A battery life calculation with available programming history established -1. 65 yrs remaining until end-of-svc, indicating the generator likely reached end-of-svc within the expected timeframe based on programmed settings.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1009721


Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 16, 2011, 10:10:53 AM
Model Number 300-20
Event Date 01/08/2008
Event Type Injury Patient Outcome Other;
Event Description
Rptr indicated a vns pt was experiencing intolerable painful neck stimulation and increased seizures. The seizure level is at pre-vns baseline levels. X-rays reviewed by the mfr did not identify any obvious lead discontinuities. A surgery consult has occurred but no surgery date has been set.

Manufacturer Narrative
Results: x-rays reviewed by the mfr; no gross lead discontinuities visualized.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1009722



Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 16, 2011, 10:11:49 AM
Event Date 07/24/2007
Event Type Injury
Patient Outcome Other;
Event Description
Review of an article revealed that a vns pt's seizures increased in frequency and was considered a poor responder to vns system.

Manufacturer Narrative
Abubakr, abuhuziefa, et al. "long-term outcome of vagus nerve stimulation therapy in pts with refractory epilepsy. " science direct.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1007343


Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 16, 2011, 02:55:06 PM
Model Number 102
Event Date 01/31/2008
Event Type Injury Patient Outcome Other;
Manufacturer Narrative
Device malfunction is suspected, but did not cause or contribute to a death.

Event Description
The reporter indicated the patient has experienced an increase in seizures. The patient states "she can tell her vns needs a battery change as she is starting to have seizures often and regular. " the patient's neurologist has relocated to another area. Therefore, the patient contacted case management for guidance on finding a neurologist treating vns patients. Good faith attempts for additional information are in progress and awaiting results.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1007410



Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 16, 2011, 02:56:27 PM
Device Problem Unknown (for use when the device problem is not known)
Event Date 07/27/2007
 Event Type Malfunction
Event Description
Article published in brain and development official journal of the japanese society of child neurology. Article titled, comparison of corpus callosotomy and vagus nerve stimulation in children with lennox-gastaut syndrome was received at mfr for review. Increase in seizures was reported in a pt and it is unk if the event was over the pre vns seizures rate. No further details known. No additional info will be provided by the site.

Manufacturer Narrative
Device malfunction cannot be ruled out. Event did not contribute to a death or serious injury.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1810845



Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 16, 2011, 02:56:58 PM
Device Problem Unknown (for use when the device problem is not known)
Event Date 07/27/2007
Event Type Malfunction
Event Description
Article published in brain and development official journal of the japanese society of child neurology. Article titled, comparison of corpus callosotomy and vagus nerve stimulation in children with lennox-gastaut syndrome was received at mfr for review. Increase in seizures was reported in a pt and it is unk if the event was over the pre vns seizure rate. No further details known. No additional info will be provided by the site.

Manufacturer Narrative
Device malfunction cannot be ruled out. Event did not contribute to a death or serious injury.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1810846



Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 16, 2011, 02:57:39 PM
Model Number 102
Event Date 01/25/2008
Event Type Injury Patient Outcome Other;
Event Description
It was reported that a vns patient was experiencing 10 to 15 complex partial seizures a day and 4 to 5 generalized tonic-clonic seizures per day. In one weekend, the patient experienced up to 40 seizures. The current seizure level's relationship to pre-vns baseline level is unk. It was also reported that the generator was at end of service. Generator revision surgery occurred. Good faith attempts to obtain add'l info have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1004232


Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 16, 2011, 02:58:30 PM
Model Number 103
Event Date 01/01/2008
Event Type Malfunction
Patient Outcome Hospitalization;
Event Description
Reporter indicated a vns patient presented with an increase in seizures and not being able to sense magnet mode stimulation. The device was found to be reset to 0ma both normal and magnet mode. The patient has spent "almost the whole time after new year in the hospital due to very difficult seizure situation with 20-30 seizures a day. " the patient's pre-vns seizure activity level is unknown. The patient's family cannot recall any situations where the child had been exposed to electromagnetic field that could have disabled the device. The patient was re-programmed to the desired settings. Good faith attempts to obtain additional information have been unsuccessful to date.

Manufacturer Narrative
Device malfunction is suspected, but did not cause or contribute to a death.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1003309


Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 16, 2011, 02:59:30 PM
Model Number 102
Event Date 09/21/2007
Event Type Injury Patient Outcome Other;
Event Description
Reporter indicated that a patient experienced a seizure increase, relationship to pre-vns baseline unknown. A battery life estimation indicated that the generator was near end of service. The patient's medications were increased to mitigate the seizure increase. The treating medical professional believes that the seizure increase is possibly due to the generator being at end of service. Good faith attempts for additional information have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=933124



Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 16, 2011, 03:00:30 PM
Model Number 102
Event Date 09/01/2007
Event Type Malfunction Patient Outcome Other;
Event Description
Initial reporter sent a fax to mfr for an end of service life battery calculation. Additionally, it was reported that it was the pt''s first visit with us", and the patient was having "an increase in seizure activity, question end of battery life. " a battery life estimate was performed using the programming history provided by the site, and it did not show the generator to be at or near end of battery life. Good faith attempts are being made for additional info.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=933847


Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 16, 2011, 03:02:22 PM
Model Number 302-20
Event Date 09/01/2007
Event Type Malfunction Patient Outcome Other;
E
vent Description
Reporter indicated the pt presented to the physician's office with a break through seizure. Subsequent system diagnostics and normal mode diagnostic tests yielded high impedance. X-ray were reviewed by mfr and no discontinuities were visualized. Pt denied any trauma or manipulation. The generator was programmed generator off. The pt underwent vns therapy system replacement surgery. Good faith attempts to obtain info ruling out device malfunction have been made, but have been unsuccessful to date.

Manufacturer Narrative
X-rays received by mfr. X-rays reviewed by mfr showed no lead discontinuities. Device malfunction is suspected, but did not cause or contribute to a death or serious injury.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=933922



Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 16, 2011, 03:04:25 PM
Model Number 101
Event Date 09/25/2007
Event Type Injury Patient Outcome Other;
Event Description
Reporter indicated that a vns pt was experiencing an increase in seizures above pre-vns baseline. Both normal mode and system diagnostic testing performed indicated the device is functioning properly. A battery life calculation indicated 0. 76 years until end of service. The cause for the increase in seizures is unknown.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=932321



Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 16, 2011, 03:05:37 PM
Model Number 102
Event Date 01/01/2007
Event Type Injury Patient Outcome Other;
Event Description
Reporter indicated a patient had an increase in seizures. The pre-vns baseline seizure level is unknown. No further information is known.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=931635



Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 16, 2011, 03:07:23 PM
Model Number 300-20
Event Date 06/01/2007
Event Type Malfunction
Event Description
Received an implant card which indicated that a pt's vns generator and lead were replaced due to "malfunction. " follow up with the neurologist revealed that high lead impedance had been detected prior to surgery. The surgeon reported that he first attempted to replace only the generator, but high impedance was still detected and the lead was then replaced as well. It was also reported that the pt had experienced an increase in seizures below pre-vns baseline prior to revision surgery. It was reported that the cause of the high lead impedance had not been determined during surgery, no trauma or manipulation of the device had occurred, and that the neurologist noted the lead was intact during review of chest x-rays.

Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=929790





Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 16, 2011, 03:08:15 PM
*  Event Date 01/01/2007
Event Type Injury
Patient Outcome Hospitalization;
Event Description
Reporter indicated that a patient who had vns implanted for treatment of depression began to have seizures after implantation of the vns device. It was also reported that patient was hospitalized for seizures on three separate occasions, and at one time patient was "unresponsive and blue". Follow up with the reporter indicated that the patient's family has a history of seizures, although the patient had no personal history of seizures prior vns implant. It was also reported that the patient has history of heart arrhythmia and "many psychological disorders". The reporter did not have any additional information.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=930207



Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 16, 2011, 03:09:29 PM
Model Number 102
Event Date 01/01/2007
Event Type Injury
Event Description
Reporter indicated a vns patient was experiencing an increase in seizures. It is unknown whether the seizure increase is greater than pre-vns baseline levels. The patient is seeking another neurologist at this time.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=930182



Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 16, 2011, 03:11:47 PM
Event Description
Reporter indicated the pt presented to the physician's office with an increase in seizures. Subsequent diagnostic testing yielded high lead impedance on a system diagnostics test, indicating a possible lead malfunction. The physician's office stated they are unsure if the "increase in seizures" is related to the vns therapy system because the pt has a history of pseudo-seizures and psychosocial issues. They do not know for sure "what is seizure activity and what is not. " the pt was hospitalized for monitoring and egative. The pt denies trauma and denies manipulating the device. The pt's generator was programmed off.

Manufacturer Narrative
Device malfunction is suspected, but did not cause or contribute to a death or serious injury.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=931709



Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 16, 2011, 03:17:31 PM
Model Number 102
Event Date 09/20/2007
Event Type Death Patient Outcome Other;
Event Description
Reporter indicated the patient's vns device was turned off to facilitate a mri and that the patient was "admitted after going into status epilepticus and has developed an anoxic brain injury. " further follow-up with the treating physician indicated that 5 days previous to the report that the patient's device had been turned off for an mri, the patient "presented to the hospital emergency room with severe status epilepticus and a ph of 6. 7. The patient was promptly given fluid volume and seizures resuscitated with intubation and placed a tlc and arterial line. She was given volume resuscitation. She was given ativan, phenytoin and phenobarbital for seizure control, which controlled this over the next 24 hours. " the status epilepticus was stabilized. The patient was "neurologically devastated" and "failed to regain more than brain stem reflexes over the next week in hospitalization. " life support was discussed with the family and subsequently, she was allowed to expire.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=932306





Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 16, 2011, 05:36:22 PM
Model Number 101
Event Date 09/01/2009
Event Type Injury Patient Outcome Required Intervention;
Event Description
It was reported to the manufacturer that the vns patient has been experiencing an increase in seizure activity for a period of time. It is unknown if the increase is above pre-vns baseline. The relationship between vns therapy and the increase in seizure activity is unknown. The patient's generator was replaced prophylactically. Good faith attempts to obtain the explanted product and additional information regarding the reported event have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1513586



Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 16, 2011, 05:37:19 PM
Model


Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 16, 2011, 05:38:52 PM
Event Date 08/01/2007
Event Type Injury Patient Outcome Other;
Event Description
The reporter indicated the patient has a newly reported type of seizures, "myoclonic twitches". The reporter indicated the patient did not have myoclonic seizures prior to implantation of the device, and the treating physician believed they are related to vns therapy. The reporter indicated that he started the patient on lorazepam medication for seizures and the vns therapy system was programmed "off". Good faith attempts are being made for more information.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=927589


Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 16, 2011, 05:40:12 PM
Event Date 08/01/2007
Event Type Injury Patient Outcome Other;
Event Description
The reporter indicated the patient has a newly reported type of seizures, "myoclonic twitches". The reporter indicated the patient did not have myoclonic seizures prior to implantation of the device, and the treating physician believed they are related to vns therapy. The reporter indicated that he started the patient on lorazepam medication for seizures and the vns therapy system was programmed "off". Good faith attempts are being made for more information.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=927589


Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 16, 2011, 05:42:57 PM
Model Number 102
Event Date 10/01/2007
Event Type Injury Patient Outcome Other;
Event Description
Reporter indicated that a pt experienced an increase in seizures, relationship to pre-vns baseline unk. The seizure increase occurred after the pt's parameters were decreased due to scm muscle spasms. Good faith attempts for add'l info have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=946697


Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 17, 2011, 02:44:35 AM
Model Number 302-20
Event Date 09/07/2007
 Event Type Malfunction Patient Outcome Other;
Manufacturer Narrative
Mfr reviewed x-rays of implanted device. X-rays reviewed by mfr, no gross lead discontinuities visualized. Device failure is suspected.

Event Description
It was reported to mfr that a sys diagnostic test performed at the vns pts follow up visit due to a recent increase in seizure activity, revealed high lead impedance. The increase in seizures was reported by the caregiver to be above the pre-vns baseline. The treating physician believes that a possible cause for the high lead impedance could be due to the pt repetitively reaching over a "half door" located at the pt's residence, which may have resulted in damaging the lead. X-rays were taken of the left chest and neck to assess the continuity of the system. The x-rays were reviewed by the mfr and no obvious discontinuities or anomalies were observed that could be contributing to the high lead impedance. The pt's device was programmed off at the time the high lead impedance was noted. The believed cause for the increase in seizures was due to lack of vns therapy. The pt had surgery to replace the problematic lead. During surgery, a lead break was discovered in the lead in the neck area and the positive helical was described by the surgeon as not being on the nerve. The explanted lead has been returned to mfr and is pending the completion of product analysis.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=925128



Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 17, 2011, 02:45:58 AM
Model Number 300-20
Event Date 09/14/2007
Event Type Malfunction
Event Description
Reporter indicated that a patient was experiencing break-through seizures that were below pre-vns baseline. A system diagnostic test resulted in a high lead impedance indicating a possible device malfunction. A complete vns system revision is scheduled. The vns generator is being replaced prophylactically.

Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=924350




Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 17, 2011, 02:47:31 AM
Model Number 102
Event Date 06/28/2007
Event Type Injury Patient Outcome Other;
Event Description
Reporter indicated a vns patient had experienced a recent increase in seizures. The reporter does not know if the seizure increase is greater than pre-vns baseline levels. Medication changes and vns parameter setting changes are being implemented as interventions.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=923247


Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 17, 2011, 02:56:53 AM
Model Number 102
Event Date 06/28/2007
Event Type Injury Patient Outcome Other;
Event Description
Reporter indicated a vns patient had experienced a recent increase in seizures. The reporter does not know if the seizure increase is greater than pre-vns baseline levels. Medication changes and vns parameter setting changes are being implemented as interventions.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=923247


Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 17, 2011, 02:57:45 AM
Model Number 302-20
Event Date 09/01/2007
Event Type Injury Patient Outcome Hospitalization; Required Intervention Other
Event Description
Reporter indicated the patient presented an office visit with an increase in seizures above the pre-vns baseline. Normal mode and system diagnostics both resulted in high lead impedance. The patient underwent vns therapy system replacement surgery. The explanted products have been returned to the manufacturer and are pending product analysis.

Manufacturer Narrative
Device malfunction is suspected, but did not cause or contribute to a death or serious injury.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=923274



Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 17, 2011, 02:58:28 AM
Model Number 102
Event Date 08/28/2007
Event Type Malfunction
Event Description
Reporter indicated that a vns patient was experiencing an increase in seizures. Further follow up indicates that a battery life calculation was performed and found the battery life to be depleted. Revision surgery was performed. Cyberonics is awaiting returned products for pa.

Manufacturer Narrative
Device malfunction suspected but did not cause or contribute to a serious injury or death.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=918802



Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 17, 2011, 04:59:12 AM
Model Number 101
Event Date 01/01/2001
Event Type Injury Patient Outcome Other;
Event Description
Reporter indicated that the pt experienced 2 seizure increases, above baseline, that were thought to be possibly related vns. The first increase was believed by the physician to be caused by a decrease in the pt's ketogenic diet or the adjustment of stimulation to rapid cycling. The second seizure increase led the treating physician to note that the taper of the ketogenic diet has increased the pt's seizures. He also believed that further adjustments of the vns have had no effect or possibly deleterious effect in seizure control. The physician reported that he hopes reprogramming the pt to parameters used previously will regain the degree of seizure control that the pt had at that time. The generator was later explanted due to end of service and returned to the mfr in 2003. An analysis was performed and no anomalies were found with the device's performance.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=919925



Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 17, 2011, 05:00:03 AM
Model Number 102
Event Date 12/01/2008
Event Type Malfunction
Event Description
It was reported that the pt was having increase in seizures and he couldn't feel magnet stimulation. Treating physician suspected that the generator had reached end of service, however, generator battery life calculated to be approx 1. 04 years until eri=yes. Good faith attempts to obtain additional information have been unsuccessful to date. The cause of increase in seizures is unk at this time.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1342191



Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 17, 2011, 05:00:44 AM
Model Number 100
Event Date 12/01/2008
Event Type Injury Patient Outcome Required Intervention;
Event Description
It was reported that the vns pt had his vns device removed due to increase in seizures and the physician is going to be putting the pt through another phase one monitoring sequence. Pt's vns device had been turned off for an extended period of time before explanting it and that it was unclear if the pt ever received efficacy from vns therapy. Good faith attempts to get additional info from the physician and to have the explanted product returned back to mfr have been unsuccessful. The cause of increase in seizures is unk at this time.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1292590


Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 17, 2011, 05:01:20 AM
Model Number 100
Event Date 12/01/2008
Event Type Injury Patient Outcome Required Intervention;
Event Description
It was reported that the vns pt had his vns device removed due to increase in seizures and the physician is going to be putting the pt through another phase one monitoring sequence. Pt's vns device had been turned off for an extended period of time before explanting it and that it was unclear if the pt ever received efficacy from vns therapy. Good faith attempts to get additional info from the physician and to have the explanted product returned back to mfr have been unsuccessful. The cause of increase in seizures is unk at this time.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1292590


Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 17, 2011, 05:02:12 AM
Model Number 302-20
Event Date 12/01/2008 Event Type Malfunction
Event Description
Initial reporter indicated to a manufacturing consultant that a vns patient was referred to their office for high lead impedance. It was discovered that only a normal mode test was performed and no system diagnostic testing was done prior to the patient being referred to the surgeon. The patient will be returning to their physician's office to have further diagnostic testing performed on their vns device. The site was informed that if they receive high lead impedance on the patient's system diagnostic testing to program the vns off. Clinic notes reviewed on the patient documented that their has been a slight increase in their seizures. It is unknown if the increase in seizures is above the patient's pre vns seizure rate. Good faith attempts to obtain additional information have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1365498




Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 17, 2011, 05:02:47 AM
Model Number 101
Event Date 01/01/2008
Event Type Injury Patient Outcome Required Intervention;
Event Description
It was initially reported that a vns pt began to experience an increase in seizures in 2008. Her device was found to be functioning properly at the time of her aeds were increased. Follow up with the physician revealed that they were unsure what the increase in seizures that occurred the same month were related to and they were above pre-vns baseline levels. The pt's seizures have increased further however, he believes this recent increase may be due to the pt's device nearing end of service. He has referred the pt for surgical consult. Revision surgery is likely.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1292038



Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 17, 2011, 05:03:26 AM
Model Number 101
Event Date 01/01/2007
Event Type Malfunction
Event Description
Reporter indicated that the patient was experiencing an increase in seizures. Cause of the increase and relationship to vns therapy is unknown at this time. Information provided did not determine whether this was an increase above pre-vns seizure levels. All attempts for further information were unsuccessful.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1340442


Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 17, 2011, 03:09:22 PM
Model Number 101
Event Date 10/13/2008
Event Type Injury Patient Outcome Other;
Event Description
Reporter indicated a patient was having increased seizure frequency and intensity episodes prior to vns generator replacement surgery. The reported noted "this is nothing new". All attempts to the reporter for additional info regarding the seizures have been unsuccessful to date. The explanted generator was likely discarded by the hospital, as hospital cannot locate the device.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1290230



Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 17, 2011, 03:10:17 PM
Model Number 102
Event Date 06/16/2008
Event Type Injury Patient Outcome Hospitalization; Required Intervention
Event Description
Clinical were received for review from the patient's treating neurologist that noted the patient to be having an increase in seizures. It is unknown if the increase documented was above or below the patient's pre vns seizure rate. The patient had their vns generator replaced and good faith attempts are being made for the product to be returned to the manufacture for analysis. Good faith attempts have been made for further info in regards to the patient's seizures, thus far no further info has been attained.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=12858



Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 17, 2011, 03:11:21 PM
Model Number 102
Event Date 12/01/2008
Event Type Injury Patient Outcome Required Intervention
Event Description
It was reported that a vns patient experienced an increase in seizures. The signal on time of the patient's vns device was increased. Additionally, the dosage of zonegran was increased. Good faith attempts to obtain additional information have been unsuccessful to date.


http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1285825




Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 17, 2011, 03:14:39 PM
Model Number 102
Event Date 12/01/2008

Event Type Injury Patient Outcome Required Intervention;
Event Description
It was reported that a vns patient experienced an increase in seizures. The signal on time of the patient's vns device was increased. Additionally, the dosage of zonegran was increased. Good faith attempts to obtain additional information have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1285825


Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 17, 2011, 03:15:34 PM
Model Number 102
Event Date 11/05/2008
Event Type Malfunction Patient Outcome Other;
Event Description
It was reported that a vns pt, who recently underwent repositioning surgery of her lead, began experiencing an increase in seizures following surgery. Diagnostic testing was not performed after the surgery. It is unk if the seizures are above, below, or at pre-vns baseline levels. Good faith attempts to obtain additional info have been unsuccessful to date

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1308712



Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 17, 2011, 03:16:26 PM
Event Date 01/01/2008
Event Type Injury
Patient Outcome Required Intervention;
Event Description
The reporter indicated in an abstract of an unpublished article that a vns patient's seizures had become more frequent with vns therapy, and that the event eventually led to device disablement. The relationship between the patient's seizure increase and vns therapy is unknown.

Manufacturer Narrative
Abstract citation: pritchard, paul, and p. Lajeunesse. "psychogenic non-epileptic seizures: contraindications to the vagus nerve stimulator?" epilepsia. (abst. 1. 137), 2008.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1283146



Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 17, 2011, 03:17:22 PM
Event Date 01/01/2008
Event Type Injury
Patient Outcome Required Intervention;
Manufacturer Narrative
Article reference; narmina dzhafarova, tejwant bindra and m. Andriola. "retrospective analysis of vagal nerve stimulator effect on the frequency of seizures at one, two and five years post placement. " epilepsia (2008).

Event Description
It was reported in an scientific article that a vns patient showed an increase in seizures. The patient had his vns removed, due to worsening of seizures. The cause of increase in seizures is unknown.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1283155




Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 17, 2011, 03:18:03 PM
Model Number UNKNOWN
Event Date 01/01/2008
Event Type Injury Patient Outcome Required Intervention;
Event Description
It was reported in an scientific article that a vns patient showed an increase in seizures. The patient had his vns removed due to worsening of seizures. The cause of increase in seizures is unknown.

Manufacturer Narrative
Article reference: narmina dzhafarova, tejwant bindra and m. Andriola. "retrospective analysis of vagal nerve stimulator effect on the frequency of seizures at one, two, and five years post placement". Epilepsia (2008).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1283156



Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 17, 2011, 03:18:46 PM
Event Date 01/01/2008
Event Type Injury
Patient Outcome Life Threatening;
Manufacturer Narrative
Article citation: corwin, hal. "minimally intractable seizures: patients reported no seizures after receiving vagus nerve stimulation. " epilepsia. (abst. 1. 084), 2008.

Event Description
The reporter indicated in an abstract of an unpublished article that a vns patient's seizures had increased from 1 seizure per month at baseline to 1-2 seizures per month with vns therapy. The reporter also indicated that the patient had been unable to receive therapeutic levels of stimulation due to medication non-compliances involving the patient's sleep apnea. The relationship between the patient's seizure increase and vns therapy is unknown.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1283202




Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 17, 2011, 03:19:30 PM
Model Number 100
Event Date 12/01/2008
Event Type Injury Patient Outcome Hospitalization;
Event Description
Initial reporter indicated that their pt was in hosp for having increased seizures. It is unk at this time if the increase in seizures is above or below their prevns seizure rate. The pt was scheduled to have their generator replaced in 2007 for being at end of battery life and it is unk if the replacement surgery occurred. Good faith attempts have been made for add'l details.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1281057


Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 17, 2011, 03:20:17 PM
Model Number 103
Event Date 02/02/2011
Event Type Injury
Event Description
A medical assistant stated that a vns pt was having painful stimulation at the generator site, which started the previous night. The pt's device had recently been turned up due to an increase in seizures, but the output current had to be decreased due to intolerance. The medical professional expressed concern that the pt was seeking medications as no treatments seemed to please the pt. Good faith attempts to date for more info on the reported events have been unsuccessful to date.

Event Description
Additional information was received indicating that the patient had a seizure and lost feeling of her left side. The patient was told by the er staff that it was todd's syndrome. The patient still has not followed up with a neurologist about her seizures. The patient now reports that the increase in seizures began (b)(6) 2011 even though the initial report came in (b)(6) 2011.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2008509


Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 17, 2011, 03:21:29 PM
Model Number 101
Event Date 12/01/2008
Event Type Injury Patient Outcome Required Intervention;
Event Description
It was reported that a vns pt was experiencing an increase in seizure activity. He has several "little seizures" daily. The use of the magnet does seem to abort the seizures. The relationship of the increased seizures to prevns baseline levels is unk. The physician indicated that upon interrogation of the vns device, the generator is near end of svc. The pt underwent generator revision surgery. Good faith attempts to obtain add'l info and the explanted product for analysis have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1281063


Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 17, 2011, 03:22:18 PM
Model Number 102
Event Date 12/02/2008
Event Type Malfunction Patient Outcome Other;
Event Description
It was reported that while in the hospital for a hip replacement surgery, a vns patient began experiencing an increase in seizures. In 24 hours, the patient experienced 57 seizures. Good faith attempts to obtain additional information have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1303848


Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 17, 2011, 03:23:08 PM
Event Date 12/01/2008
Event Type Malfunction
Event Description
It was reported to the manufacturer that the vns patient has been experiencing an increase in seizures. It was indicated that there was a recent change in the patient's epilepsy medications. The relationship between the increase in seizures and vns therapy is unknown. It is unknown if the increase is above pre-vns baseline. Good faith attempts to obtain additional information regarding the patient, and the reported event have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1350820


Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 17, 2011, 03:25:26 PM
Event Date 01/01/2003
Event Type Malfunction
Patient Outcome Other;
Event Description
The reporter indicated in a scientific article that a vns patient experienced an increase in seizure frequency and reported no improvement in well-being. The cause of the increased seizures and their relationship to vns therapy is unk. Good faith attempts for additional information have been unsuccessful to date.

Manufacturer Narrative
Article citation: murphy jv et. Al. "vagal nerve stimulation in refactory epilepsy: the first 100 patients receiving vagal nerve stimulation at a pediatric epilepsy center. " arch pediatr adolesc med 157. : 560-564, 2003.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1355957





Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 17, 2011, 03:26:28 PM
Model Number 102
Event Date 01/28/2009
Event Type Malfunction Patient Outcome Other;
Event Description
It was reported that a vns patient is having more frequent seizures. The patient also indicated that he is experiencing erratic stimulation. The patient has not seen his treating physician in over a year. The patient was scheduled for follow-up at a clinic, but did not show up. Good faith attempts to obtain additional information have been unsuccessful to date

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1355989


Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 17, 2011, 03:27:30 PM
Model Number 101
Event Date 10/11/2008
Event Type Injury
Event Description
It was reported that the pt had a grand mal seizure, which was the first in about a year. It was also reported that the pt had not been doing well for about 6-8 weeks. Good faith attempts to obtain additional info have been unsuccessful to date. It is unknown at this time what the relationship of the event is to vns.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1329154



Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 17, 2011, 03:28:29 PM
Model Number 101
Event Date 01/01/2011
Event Type  Injury   
Event Description
It was reported that the pt underwent generator replacement surgery due to end of service. The explanted generator was returned to the mfr and underwent analysis. Upon analysis, no anomalies were noted and the device was not at end of service. Further info from the surgeon reveals that the generator was replaced due to the age of the device and the pt experiencing an increase in seizure frequency. No further info can be obtained from the treating physician.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2187889


Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 17, 2011, 03:29:21 PM
Model Number 102
Event Date 01/21/2009
Event Type Injury
Patient Outcome Required Intervention;
Event Description
Reporter indicated a vns therapy patient is experiencing an increase in seizure activity. The patient's pre-vns seizure activity level is unknown. The physician reported the patient's generator is at end of service and a battery life calculation confirmed the generator to be at end of service. The patient is scheduled to undergo a generator replacement surgery. Good faith attempts to obtain additional information have been unsuccessful to date.


http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1329212



Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 17, 2011, 03:30:33 PM
Model Number 302-20
Event Date 10/01/2008
Event Type Malfunction
Event Description
Initially, it was reported that the patient was having increased seizures at or below their pre vns baseline and they were not feeling their magnet activations. An estimated battery life calculation was performed and showed the generator to have approximately 0. 16 years till being at near end of service indication. Normal mode diagnostics were performed and resulted in output status: limit, lead impedance: high, a systems diagnostic test reported to be within normal limits. The patient had their vns generator replaced for nearing end of battery life. During the generator replacement surgery with a new 103 generator implanted a systems diagnostic test was performed and high impedance was attained. The test was repeated and same results, a pin reinsertion was performed and the same results attained. The lead was replaced for a suspected lead break and after the lead was replaced system diagnostic testing was within normal limits. The patient had no reported fall or injury preceding their high impedance. Good faith attempts have been made for the explanted product to be returned for analysis and thus far no product has been returned.
Manufacturer Narrative
Device malfunction suspected, but did not cause or contribute to a death or serious injury.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1354664



Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 17, 2011, 03:31:50 PM
Model Number 100B
Event Date 01/01/2002
Event Type Injury Patient Outcome Required Intervention;
Event Description
Reporter indicated that a vns pt was having increased seizures and increased seizure intensity which was treated by replacing the vns generator. The generator was believed to be "losing effectiveness" per the reporter. A battery life yielded approx 2. 7 - 3. 5 yrs of life span for the generator at moderate settings and a 10% duty cycle. Attempts for return of the explanted generator are in progress.

Manufacturer Narrative
Device failure is not suspected as the generator was likely at end of service, due to length of implant (4. 5 years).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1321652




Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 17, 2011, 03:32:56 PM
Model Number 103
Event Date 12/13/2011
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported through an implant card that a vns patient underwent generator and lead replacement surgery due to patient experiencing seizure exacerbation. At the moment (b)(4) attempts to obtain additional information have been unsuccessful to date.

Event Description
Further information was received by the treating nurse indicating that the patient was having an increase in seizures which was not above pre-vns baseline. The nurse was unsure if the increase in seizures was due to vns. No medication changes were reported. The treating staff indicated the generator was at high duty cycle. Prior to replacement surgery, system diagnostics were normal (impedance of 2904 ohms). The explanted devices will not be returned to the manufacturer.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2404971


Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 17, 2011, 03:33:42 PM
Model Number 102R
Event Date 12/01/2008
Event Type Injury
Event Description
It was reported that the pt was having an increase in seizures. It is unk if this increase is above or below pre-vns baseline. Per the treating physician, the increase may be due to the generator being near end of service. Pt is scheduled for replacement surgery. Attempts for further info have been unsuccessful to date.


http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1321659


Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 17, 2011, 03:34:32 PM
Model Number 302-20
Event Date 10/02/2008
Event Type Malfunction
Event Description
Reporter indicated a vns therapy patient is experiencing high lead impedance and an increase in seizures. The patient's pre-vns baseline seizure activity level is unknown. The physician reviewed x-rays, which showed no obvious lead fracture. The patient is scheduled for lead revision. Good faith attempts to obtain additional information have been unsuccessful to date

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1317957


Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 17, 2011, 03:35:30 PM
Model Number 302-20
Event Date 10/02/2008
Event Type Malfunction
Event Description
Reporter indicated a vns therapy patient is experiencing high lead impedance and an increase in seizures. The patient's pre-vns baseline seizure activity level is unknown. The physician reviewed x-rays, which showed no obvious lead fracture. The patient is scheduled for lead revision. Good faith attempts to obtain additional information have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1317957



Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 17, 2011, 03:36:18 PM
Model Number 102
Event Date 01/08/2009
Event Type Malfunction
Event Description
Reporter indicated experiencing an increase in seizures above the patient's pre-vns baseline. The patient's treating physician was contacted, but did not know about the event. The physician plans to bring the patient into the office for evaluation. Good faith attempts to obtain additional information have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1353567


Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 17, 2011, 03:36:59 PM
Model Number 101
Event Date 10/01/2008
Event Type Injury Patient Outcome Other;
Event Description
Reporter indicated that the patient was having increased seizures and painful stimulation along the vns lead. The patient later underwent generator replacement surgery only. The reporter has stated she will not respond to requests for further information. A battery life estimate yielded approximately 5. 4 years remaining for the generator. Attempts for return of the explanted generator have been unsuccessful to date.


http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1310982



Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 17, 2011, 03:37:36 PM
Model Number 102
Event Date 06/01/2008
Event Type Malfunction
Patient Outcome Required Intervention;
Manufacturer Narrative
Device failure is suspected.
Event Description
It was reported to manufacturer that the vns patient was tasered in (b) (6) 2008. At the time of the event, the patient felt a rapid sensation in the neck and has not felt stimulation of the device since that time. The patient reported to the physician a recent increase in seizure activity, relationship to pre-vns baseline unknown. When the patient was seen by the physician for a recent follow up appointment, communication was not able to be established with the patients generator. The patient subsequently had surgery where the generator was replaced. Attempts to obtain additional information from the treating physician have been unsuccessful to date. Additionally, attempts to obtain the explanted generator for analysis have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1311053



Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 17, 2011, 03:39:10 PM
Model Number 101
Event Date 12/01/2008
Event Type Malfunction
Event Description
It was reported that the patient has increased seizures. Physician states that the device is most likely "not working correctly", however, eri = no. Physician feels patient should have surgery as the device is old and the patient is having increased seizure activity. Patient had surgical consult and revision surgery is likely.

Manufacturer Narrative
Device failure is suspected


http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1348845



Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 17, 2011, 03:40:34 PM
Model Number 102
Event Date 01/01/2009
Event Type Malfunction
Event Description
It was initially reported that the patient was reporting lack of efficacy and that the patient's parents had requested that the device not be replaced upon battery depletion. It was later reported that the patient was having an increase in seizures since the treatment of the patient had been transferred to the current physician. The patient has received treatment from two other physicians. Pre-vns baseline levels are unknown for this patient and the seizures have fluctuated over time since patient has began treatment of seizures. The current treating physician feels that the patient is just not responding to vns therapy despite programming changes and adjustments to aed medications. There is no suspected device failure. The relationship between the increase in seizures and vns therapy is unknown at this time.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1348846



Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 17, 2011, 03:41:57 PM
Model Number 302-20
Event Date 01/01/2009
Event Type Injury Patient Outcome Required Intervention;
Event Description
It was reported that a vns patient was experiencing an increase in seizures. The patient had 2 grand mal seizures and was sent to the er. It is unknown if the seizures were above, below or at prevents baseline seizure levels. Since the patient recently underwent generator revision surgery, the vns settings were lower than what the patient had previously been at. The patient also had some external stressors and was noncompliant with medications that may have contributed to the increase in seizures. Diagnostics showed vns to be functioning properly. Nevertheless, the patient's lead was replaced. The explanted lead has been returned to the manufacturer and is undergoing analysis. Good faith attempts to obtain the medical professional's assessment have been unsuccessful to date.


http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1306395


Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 17, 2011, 03:43:24 PM
Model Number 302-20
Event Date 01/01/2009
Event Type Malfunction
Event Description
It was reported that the vns pt had a high lead impedance and was having increase in seizures for the past few weeks. Battery life calculation was performed and it was noticed that the generator has approx -0. 59 years before eri=yes. However, diagnostics results showed eri=no. Follow up with the physician revealed that the pt will undergo a revision surgery. No pt manipulation or trauma has been reported and no changes in medication preceded to the onset of the event. X-rays were reviewed and it was noticed that the leads were not fully inserted into the generator connector block. Pt's generator was replaced and surgeon noticed that lead was not fully inserted which was causing the high lead impedance. Physician believes the increase in seizures is due to high lead impedance since pt is receiving no stimulation.

Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. Review of x-rays by the manufacturer, lead pin not fully inserted into the generator connector block. Device failure occurred, but did not cause or contribute to a death or serious injury.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1346411


Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 17, 2011, 03:44:21 PM
Event Date 06/13/2006
 Event Type Injury
Patient Outcome Other;
Event Description
It was reported in an article following pediatric pts that were implanted with vns that a pt with a history multifocal epilepsy experienced an increase in seizures following vns implant. There is no allegation of device malfunction. Good faith attempts to obtain additional information from the author of the article have been unsuccessful to date.

Manufacturer Narrative
Article: long-term results with vagus nerve stimulation in children with pharmacoresistant epilepsy. Alexopoulos, a. Et al. Seizures 2006 pp 1-13. (see scanned pages).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1303643



Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 17, 2011, 03:45:05 PM
Event Date 06/13/2006 '
Event Type Injury
Patient Outcome Other;
Manufacturer Narrative
Article: long-term results with vagus nerve stimulation in children with pharmacoresistant epilepsy. Alexopoulos, a. Et al. Seizures 2006 pp 1-13. (see scanned pages).

Event Description
It was reported in an article following pediatric pts that were implanted with vns that a pt with generalized epilepsy experienced two generalized tonic-clonic seizures for the first time after starting vns. Also, habitual myoclonic seizures became "longer and harder" according to the pt's parents. There is no allegation of device malfunction. Good faith attempts to obtain additional information from the author of the article have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1303645



Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 17, 2011, 03:46:08 PM
Event Date 06/13/2006
Event Type Injury
Patient Outcome Other;
Manufacturer Narrative
Article: long-term results with vagus nerve stimulation in children with pharmacoresistant epilepsy. Alexopoulos, a. Et al. Seizures 2006 pp 1-13. (see scanned pages).

Event Description
It was reported in an article following pediatric pts that were implanted with vns that a pt with multifocal epilepsy experienced an increase in seizures. There is no allegation of device malfunction. Good faith attempts to obtain additional information from the author of the article have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1303648



Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 17, 2011, 03:46:51 PM
Model Number 302-20
Event Date 12/24/2008
Event Type Malfunction
Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. Results - x-rays reviewed by the manufacturer, no gross lead discontinuities visualized. Conclusions - device failure is suspected, but did not cause or contribute to a death or serious injury.

Event Description
It was reported that diagnostic testing resulted in high impedance. The patient also reported an increase in seizures and not perceiving stimulation. Follow up with the physician revealed that the increase in seizures was due to a lack of therapy and that the patient did not report not perceiving stimulation from the device. The increase in seizures was below pre-vns baseline. X-rays were reviewed by the manufacturer and no obvious lead discontinuities were found. Patient underwent full revision surgery. Good faith attempts to obtain the explanted product have been unsuccessful to date

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1344188




Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 18, 2011, 05:53:35 AM
Model Number 102
Event Date 01/27/2009
Event Type Malfunction
Event Description
Clinical notes were received by the manufacturer from the vns patient's physician during the investigation of the patient's death. The treating physician determined that the death was not related to vns therapy, rather the patient's respiratory condition and the patient ultimately dies due to respiratory distress and cardiac arrest. Within the clinic noted received was detail of a follow up appointment that occurred two weeks prior to the death. At this appointment, it was noted that the mother noticed, after the patients' recent hospitalization, that the patient was "having more staring seizures, which typically occur in clusters, lasting for a few seconds. The seizures occur sporadically and have decreased over the past week. " there was no note of interventions taken for the adverse event. The vns device was interrogated and a normal mode diagnostic test was performed revealing normal device function. There were no setting changes performed. The physician noted that the plan was to check the patients' medication levels and schedule an eeg to assess the ictal and interictal abnormalities. The patients current antiepileptic drug medications were noted as lamictal, depakote, and clobazam. Good faith attempts were made with the physician to obtain additional information regarding this event, but have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1358277



Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 18, 2011, 05:54:34 AM
Event Date 01/01/2000
Event Type Malfunction
Event Description
It was reported in a scientific article that a vns pt experienced an increase in seizures. Follow up with the physician did not reveal new info as the article was published in 2000 and the physician reported that it is unlikely that she could obtain additional info about the pt. Good faith attempts to obtain additional info have been unsuccessful to date. It is unclear if the increase in seizures is above pre-vns therapy baseline level. The cause of the increase in seizures and the relationship to vns therapy is unk at this time.

Manufacturer Narrative
Cynthia harden, melissa pulver, lisa ravdin, blagovest nikolov, james halper, and douglas labar. "a pilot study of mood in epilepsy patients treated with vagus nerve stimulation. " 2000:93-99.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1358279



Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 18, 2011, 05:55:24 AM
Event Date 01/01/2000
Event Type Malfunction
Event Description
It was reported in a scientific article that a vns pt experienced an increase in seizures. Follow up with the physician did not reveal new info as the article was published in 2000 and the physician reported that it is unlikely that she could obtain additional info about the pt. Good faith attempts to obtain additional info have been unsuccessful to date. It is unclear if the increase in seizures is above pre-vns therapy baseline level. The cause of the increase in seizures and the relationship to vns therapy is unk at this time.

Manufacturer Narrative
Cynthia harden, melissa pulver, lisa ravdin, blagovest nikolov, james halper, and douglas labar. "a pilot study of mood in epilepsy patients treated with vagus nerve stimulation. " 2000:93-99.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1358279



Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 18, 2011, 05:56:05 AM
Event Date 01/01/2000
Event Type Malfunction
Event Description
It was reported in a scientific article that a vns pt experienced an increase in seizures. Follow up with the physician did not reveal new info as the article was published in 2000 and the physician reported that it is unlikely that she could obtain additional info about the pt. Good faith attempts to obtain additional info have been unsuccessful to date. It is unclear if the increase in seizures is above pre-vns therapy baseline level. The cause of the increase in seizures and the relationship to vns therapy is unk at this time.

Manufacturer Narrative
Cynthia harden, melissa pulver, lisa ravdin, blagovest nikolov, james halper, and douglas labar. "a pilot study of mood in epilepsy patients treated with vagus nerve stimulation. " 2000:93-99.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1358279



Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 18, 2011, 05:56:56 AM
Model Number 102
Event Date 02/03/2009
Event Type Injury Patient Outcome Hospitalization;
Event Description
It was reported that a vns patient was hospitalized due to continuous seizures. The last time the patient's vns device had been checked was two years ago. The patient was sent to a neurologist who could check his vns device. Follow up with that neurologist revealed that he believed the generator has reached end of service as he cannot communicate with it. The neurologist believes the vns device could have been at end of service for a long time. The neurologist has no past records on the patient, so the relationship of the patient's current seizure level to pre-vns baseline is unknown. Generator revision surgery is likely.


http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1336517



Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 18, 2011, 05:58:00 AM
Model Number 102
Event Date 01/23/2008
Event Type Injury Patient Outcome Required Intervention;
Event Description
It was reported that a vns pt had experienced an increase in seizures, which coincided with staphylococcus infection under her left arm, the event was resolved with medication, and that prior to the event there had been no medication changes. F/u with the pt's treating vns therapy physician revealed that the event was related to the pt's revision surgery, and indicated that prior to the infections development there had been no admissions of pt trauma or manipulation. The physician also indicated that the infection was believed to have exacerbated the pt's seizure condition.

Manufacturer Narrative
Device manufacturing records were reviewed. Review of the manufacturing records confirmed sterilization for both the generator and lead prior to distribution.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1333226



Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 18, 2011, 05:58:55 AM
Event Date 04/30/2001
Event Type Malfunction
Event Description
The author of a scientific article indicated that a vns patient experienced an increase in seizures above the pre-vns baseline. The cause of these seizures and their relationship to vns therapy is unk. Good faith attempts for additional information have been unsuccessful to date.

Manufacturer Narrative
Article citation: hoppe, christian, chris helmstaedter, ph. D, judith scherrmann, md, and christian e. Elger, md. "self-reported mood changes following 6 months of vagus nerve stimulation in epilepsy patients. " epilepsy & behavior 2 (2001): 335-42.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1358065



Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 18, 2011, 05:59:46 AM
Model Number 302-20
Event Date 01/01/2006
Event Type Malfunction Patient Outcome Other;
Event Description
Reporter indicated that she was having increased seizures greater than her pre-vns baseline level that started 3 years ago when the vns lead was "ripped off the nerve" when she was choked by someone. She stated her neurologist informed her the vns did not work, but that it was still turned on to low settings. The manufacturer recommended the pt follow up with her neurologist. All attempts to the reporter's neurologist have been unsuccessful to date

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1359657


Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 18, 2011, 06:00:37 AM
Model Number 100
Event Date 01/28/2000
Event Type Injury Patient Outcome Required Intervention;
Event Description
Review of pt clinic notes received by the pt's treating physician revealed the pt experienced an increase in seizures in 2001, but the relationship of the seizures to pre-vns levels unk. The physician noted "when the vagal nerve stimulator is turned up, he does better and his speech becomes clear. " the pt's generator output current was increased to 2. 0 ma output current. At the next office visit the following month, the output current was again increased to 2. 25 ma. The office note for the following month, stated the pt was not having any seizures. The pt's vns generator was replaced in 2003, due to end of service. Good faith attempts to obtain additional info have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1353210



Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 18, 2011, 06:05:58 AM
Model Number 102
Event Date 01/01/2008
Event Type Injury Patient Outcome Required Intervention;
Event Description
The reporter indicated that a vns patient was continuing to have seizures since her last follow up visit. The patient's mother indicated that the patient had experienced an increase in drop attack seizures with a decrease in therapy frequency. The patient's treating vns therapy physician opted to increase the patient's therapy frequency to address the seizure issue. Device diagnostics were performed and confirmed proper device function, though the device was found to be near end of service. A battery longevity estimate was performed and confirmed that the end of service condition was an expected event. The relationship between the patient's seizure increase, and the pre-vns baseline is unknown. Good faith attempts for additional information have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1352380



Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 18, 2011, 06:06:53 AM
Model Number 300-20
Event Date 03/12/2008
Event Type Malfunction
Manufacturer Narrative
Device failure is suspected. See scanned page.

Event Description
It was reported that a vns patient was experiencing an increase in seizures. Diagnostics were performed on the patient's device and reportedly resulted in a high impedance warning. The patient's treating vns therapy physician indicated that he believed that the patient's increased seizure activity was due to a loss of therapy resulting from the high impedance event. The patient underwent lead revision surgery, good faith attempts for product return are in progress.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1362344



Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 18, 2011, 06:07:44 AM
Model Number 101
Event Date 11/01/2008
Event Type Injury Patient Outcome Required Intervention;
Event Description
Initial reporter indicated that a vns patient experienced an increase in staring spell seizures. Additional information received revealed that the pt underwent generator replacement. Programming history revealed that the device was not approaching end of service. The cause of the increase in seizures and the relationship to vns therapy is unk at this time. Good faith attempts to obtain additional information have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1351502


Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 18, 2011, 06:09:19 AM
Model Number 302-20
Event Date 02/01/2009
Event Type Malfunction
Patient Outcome Required Intervention;
Manufacturer Narrative
Device failure is suspected, but did not cause or contributed to a death.

Event Description
It was reported that the patient had an increase in seizures and the increase was above pre-vns baseline. Patient's diagnostics results showed high lead impedance. No patient trauma or manipulation was reported. Physician does not know when the last good diagnostics results were obtained. Patient could no longer feel stimulation. Physician does not know the exact date when the increase in seizures began or when the patient stopped feeling stimulation but it was "recently. " no x-rays were taken and patient's device is currently turned off. Follow-up with the physician's office revealed that the increase in seizures is possibly due to high lead impedance/no stimulation received. It was indicated that the increase in seizures is not due to any medication changes or any external factors. Patient underwent a full revision surgery. Good faith attempts to obtain explanted product have been unsuccessful till date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1415372



Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 18, 2011, 06:09:54 AM
Model Number 302-20
vent Date 01/01/2009
Event Type Malfunction
Event Description
It was reported that a vns pt, who is currently incarcerated, had experienced an increase in seizures after being beaten by one of the correctional facilities guards. The pt's mother indicated that she suspected that the pt's device may have been damaged during the beating, but that the pt had not seen a treating vns therapy physician for several years and that it was unk whether he would be able to follow up with his physician at this time. Follow up with the pt most current treating vns therapy physician revealed that the site had not been contacted regarding a follow up visit.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1362511


Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 18, 2011, 06:10:35 AM
Model Number 102
Event Date 02/21/2007
Event Type Injury Patient Outcome Other;
Event Description
Reporter indicated via physician clinic notes that a vns therapy pt experienced an "initial increase in seizure frequency after last adjustment" in 2007. The pt's pre-vns baseline is unk. A battery life calculation revealed the pt's vns generator is -0. 68 years until the elective replacement indicator read "yes. " good faith attempts to obtain additional info have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1347125





Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 18, 2011, 06:11:29 AM
Model Number 101
Event Date 11/01/2008
Event Type Injury Patient Outcome Required Intervention;
Event Description
Initial reporter indicated that a vns patient experienced an increase in staring spell seizures. Additional information received revealed that the pt underwent generator replacement. Programming history revealed that the device was not approaching end of service. The cause of the increase in seizures and the relationship to vns therapy is unk at this time. Good faith attempts to obtain additional information have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1351502



Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 18, 2011, 06:25:45 AM
Event Date 02/01/2009
Event Type Malfunction
Event Description
Physician had reported that the patient has an increase in seizures, but still feels stimulation. Good faith attempts to obtain additional information have been unsuccessful. The cause of increase in seizures is unknown at this time.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1363485




Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 18, 2011, 06:26:28 AM
Model Number 102R
Event Date 01/01/2009
Event Type Malfunction
Event Description
It was reported to the manufacturer that the vns patient has been experiencing an increase in seizures above pre-vns baseline. The relationship between the increase in seizures and vns therapy is unknown at this time. Good faith attempts to obtain additional information regarding the reported event have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1363483



Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 18, 2011, 06:27:36 AM
Model Number 101
Event Date 02/01/2009
Event Type Injury Patient Outcome Required Intervention;
Event Description
Reporter indicated that the pt was experiencing an increase in seizures. The physician was unsure whether or not this increase was above or below the pt's pre-implant baseline levels. The pt has been implanted for several years, and the physician believes the increase may be due to the device nearing end of service however, normal mode diagnostics performed at the time of the report did not have any end of service flags. There were no reports of pt manipulation or trauma or of any programming or medication changes that occurred prior to the onset of the increase in seizures. The pt's device had been replaced: however, the explanted generator has not been returned to the for analysis.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1353214





Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 18, 2011, 11:17:18 AM
Model Number 103
Event Date 03/16/2009
Event Type Injury Patient Outcome Other;
Event Description
It was reported that the vns patient experienced a seizure worse than pre-vns baseline with post-ictal period longer than normal. It was not specified what defined that episode as worse than normal. The severity of the seizure is unknown at this time. The relationship between the reported episode and vns therapy is unknown at this time. Good faith attempts to obtain additional information regarding the reported event have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1363743


Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 18, 2011, 11:17:58 AM
Model Number 102
Event Date 01/01/2009
Event Type Injury Patient Outcome Required Intervention;
Event Description
Reporter indicated that the patient was experiencing an increase in seizures. The patient is scheduled to have the device replaced. All attempts for more information were unsuccessful, thus the relationship between the increase in seizures and vns therapy is currently unknown.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1362603


Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 18, 2011, 11:18:29 AM
Model Number 101
Event Date 03/13/2009
Event Type Malfunction
Event Description
It was reported that the pt was having an increase in seizures. No further information has been provided at this time. It is unclear what the relationship of the device is to that of the pt's increase in seizures. It is also unk if the pt's current increase in seizures is greater than the levels prior to the vns therapy. Good faith attempts to obtain additional information have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1419797




Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 18, 2011, 11:18:58 AM
Model Number 102
Event Date 12/01/2008
Event Type Malfunction Patient Outcome Hospitalization; Required Intervention
Event Description
Reporter indicated that the patient had been hospitalized for a flurry of seizures. The treating neurologist stated that she believed that the event was caused by the generator battery being depleted, but the generator could not be interrogated to be sure, and believes that the battery went dead prematurely. Attempts for more information were unsuccessful. Due to the generator being believed to be at end of service, the patient underwent a full replacement surgery. The generator has been returned to the manufacturer for analysis, but analysis is not yet complete


http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1429510


Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 18, 2011, 11:19:41 AM
Model Number 101
Event Date 01/01/2009
Event Type Malfunction
Event Description
It was reported that a vns patient experienced an increase in seizures. At the moment, the relationship of the increase in seizures to vns therapy and to pre-vns baseline seizure level in unknown. Good faith attempts to obtain additional information have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1429525



Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 18, 2011, 11:20:10 AM
Model Number 102
Event Date 03/04/2009
Event Type Injury Patient Outcome Other;
Event Description
Initial reporter indicated that the pt had been having an increase in seizures over their pre vns rate recently. The pt had varying seizures rates since implant but not in their past over their pre vns rate. Unclear what increase in seizures is being related to. Pt has been scheduled to have their vns generator replaced for nearing end of battery life. Device diagnostics reported to be within normal limits. Pt is currently receiving their therapy based on results.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1357855



Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 18, 2011, 11:20:50 AM
Event Date 01/01/2009
Event Type Injury Patient Outcome Required Intervention;
Event Description
It was reported that lowering the vns device parameters caused a pt to experience an increase in seizures. Moreover, it was also reported that the pt is at its best in the current settings based on an electroencephalogram taken by the medical professional. However, at the moment, it is unk if the increase in seizures is below or above pre-vns baseline. Good faith attempts to obtain additional info have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1357856



Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 18, 2011, 11:21:27 AM
Model Number 103
Event Date 03/01/2009
Event Type Malfunction
Event Description
It was reported that a pt experienced an increase in seizures. The relationship of the increase in seizures to vns therapy is unk. Good faith attempts to obtain additional info from the medical professional have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1424411


Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 18, 2011, 11:22:07 AM
Model Number 102R
Event Date 01/01/2009
Event Type Malfunction
Event Description
It was reported that the pt was having an increase in seizures. The pt had indicated that she has been "seizure free" for about six years until the most recent implant. It is unknown at this time what the physician's assesment is of the increase in seizures is to that of the device. It is unknown if the increase in seizures is more than the levels prior to the start of vns therapy. Good faith attempts to obtain additional info have been unsuccessful to date.


 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1424613


Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 18, 2011, 11:23:09 AM
Event Date 01/01/1998
Event Type Injury Patient Outcome Other;
Event Description
It was reported in a scientific article that the pt experienced a greater than 50 percent increase in seizures after three months of vns therapy. It is known that the device was not explanted during the study period. No further info was provided. Attempts for further info have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1355261



Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 18, 2011, 11:23:45 AM
Event Date 01/01/1998
Event Type Injury Patient Outcome Other;
Event Description
It was reported in a scientific article that the pt experienced a greater than 25 percent increase in seizures after three months of vns therapy. It is known that the device was not explanted during the study period. No further info was provided. Attempts for further info have been unsuccessful to date

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1355264


Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 18, 2011, 11:24:30 AM
Model Number 103
Event Date 03/01/2013
Event Type  Injury   
Event Description
It was reported that the patient experienced hoarseness after vns implant surgery. (b)(6) 2013 - symptoms of cough and hoarseness sometimes, but only when the physician; press, not every time;. It continues to increase, but pulse width was reduced to 250 microseconds. (b)(6) 2013: per the physician, vns output current increased to 1. 25 ma. Hoarseness and increase of seizure when; i press. Put back to 0. 75 ma and pulse width to 500 microseconds. (b)(6) 2013: on his return to the clinic, the patient's hoarseness was still ongoing and pulse width back to 250 microseconds. (b)(6) 2013: hoarseness is ongoing. The patient's seizure frequency has reduced greatly. Advised from the ear nose throat (ent) specialist that the patient has left vocal cord paralysis. The vns was turned off to see if this gives improvement. As of (b)(6) 2013, there was no improvement in the hoarseness. The ent did not see any improvement. The seizures increased; however, follow up found that the increase was due to loss of therapy and was at the pre-vns baseline levels. Both seizure types increased. The increase occurred four weeks after the vns was turned off. The vocal cord paralysis was first observed on (b)(6), 2013. Upon first stimulation, the patient gives a hoarse voice, but after decreasing the output current and increasing the pulse width the patient has the hoarse voice all day. So it was related to stimulation, per the physician. After surgery, the patient had no complaints of a hoarse voice. Patient is going to speech therapy and has an appointment with the physician for controlling vocal cord paralysis. The patient does not have a medical history of vocal cord paralysis prior to vns. (b)(6) 2013: no hoarseness improvement, no improvement seen in ent, but seizures increased again. Yet vns shows next week, no expectation that the vocal cord can be affected too. No other information was provided.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3528942


Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 18, 2011, 11:25:07 AM
Model Number 102
Event Date 12/01/2011
Event Type  Injury   
Manufacturer Narrative
Event Description
Additional information was received from the treating nurse indicating the reason for the reported pain was unknown and was not associated with vns stimulation. The pain was reported to have been located in the chest area and even some in the neck and left arm. Diagnostics at the time were within normal limits. Moreover, the nurse reported the patient's seizures increased; however the patient is noted to have an increase in seizures yearly. Analysis was completed on the returned generator. Analysis of the generator indicated pulse generator diagnostics were as expected for the programmed parameters. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications.

Event Description
It was reported by a nurse that a vns patient was explanted due to local pain and sensibility. The patient was reported to have an increase in seizures after explant; however the patient's pain resolved after explant. The explanted generator was returned to the manufacturer and currently undergoing analysis. Good faith attempts to obtain further information from the treating nurse have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2465722


Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 19, 2011, 01:11:17 AM
Model Number 102
Event Date 09/01/2008
Event Type Injury Patient Outcome Other;
 Event Description
Reporter indicated a vns therapy is experiencing a "dramatic increase in her seizure frequency. " additionally, the pt perceives the stimulation is weaker. The physician stated an interrogation of the vns generator indicated it is "nearing its end of life. " good faith attempts to obtain additional info have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1373575



Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 19, 2011, 01:12:09 AM
Model Number 102
Event Date 04/01/2009
Event Type Injury Patient Outcome Life Threatening; Hospitalization Required Intervention
Event Description
It was reported that the pt was experiencing an increase in seizures above pre-vns baseline. During these seizures, the pt was having episodes of asystole. Pt was hospitalized and implanted with a pacemaker as a result. Per the treating medical professional, it is unk if the increase in seizures and asystole are related to vns or stimulation. Device diagnostics are all within normal limits. A battery life calculation was run and shows there to be approximately 1. 61 years remaining until end of service. The pt's medication levels were measured and were at zero which indicates the pt has not been compliant with her medication. It is unk at this time if this had an effect on the seizures and/or asystole. Pt will be monitored and no further interventions are planned at this time. All attempts for additional info have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1373576



Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 19, 2011, 01:13:12 AM
Model Number 101
Event Date 01/01/2009
Event Type Injury Patient Outcome Required Intervention;
 
Event Description
It was reported by the physician that the pt was having an increase in seizure due to a possible battery depletion of the generator. Info received to date does not indicate an eri-flag has been observed. Calculation of battery life based on programming history available indicates that the battery has 0. 63 years until eri=yes. Good faith attempts to obtain additional info have been unsuccessful to date. The pt is expected to have surgery to replace the generator. The cause for the increase in seizures is unk at this time. It is unk what the relationship of the device is to that of the increase in seizures.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1373578


Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 19, 2011, 01:14:10 AM
Model Number 101
Event Date 01/01/2009
Event Type Injury Patient Outcome Required Intervention;
Event Description
It was reported by the physician that the pt was having an increase in seizure due to a possible battery depletion of the generator. Info received to date does not indicate an eri-flag has been observed. Calculation of battery life based on programming history available indicates that the battery has 0. 63 years until eri=yes. Good faith attempts to obtain additional info have been unsuccessful to date. The pt is expected to have surgery to replace the generator. The cause for the increase in seizures is unk at this time. It is unk what the relationship of the device is to that of the increase in seizures

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1373578



Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 19, 2011, 01:14:54 AM
Model Number 102R
Event Date 02/01/2009
Event Type Malfunction
Event Description
Reporter indicated a vns therapy's generator is believed to be "near end of service. " the pt has been experiencing increased seizures for the past several months. The pt's pre-vns seizure activity level is unk. A battery life calculation revealed the pt's generator is 0. 36 years until the elective replacement indicator reads "yes. " good faith attempts to obtain additional info have been unsuccessful to date.


http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1428926




Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 19, 2011, 01:15:39 AM
Model Number 102
Event Date 01/01/2009
Event Type Malfunction
Event Description
It was reported that a vns patient experienced an increase in seizures in the mornings. At the moment, the relationship of the increase in seizures to vns therapy is unknown while the pre-vns baseline is also unknown. Good faith attempts to obtain additional information from the treating neurologist have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1428935



Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 19, 2011, 01:16:22 AM
Event Date 10/01/2004
Event Type Injury
Patient Outcome Required Intervention;
Event Description
Reporter indicated that the patient had an increase in seizures. Within the clinical notes that were received, she changed the patient device settings, which seemed to resolve the issue. Attempts for more information from the treating physician have been unsuccessful to date, and thus the relationship between the increased seizures and vns therapy cannot be determined.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1402709



Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 19, 2011, 01:17:29 AM
Model Number 101
Event Date 04/01/2009
Event Type Malfunction
Event Description
It was reported that a vns pt continues to experience break through seizures. Currently the relationship of the break through seizure to vns therapy is unk as good faith attempts have been made to the treating neurologist to obtain add'l info. Pt is likely to undergo generator replacement surgery.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1455172



Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 19, 2011, 01:18:14 AM
Model Number 102R
Event Date 06/05/2011
Event Type  Injury   
Manufacturer Narrative

Event Description
Additional information was received on (b)(6), 2011 when an implant card was received from the hospital that revealed the lead impedance was within normal limits after the battery replacement surgery on (b)(6), 2011.
 
Event Description
On (b)(6) 2011, clinic notes from a vns treating physician were received through case management. Review of the clinic notes dated (b)(6) 2011 revealed that the patient had twelve seizures on (b)(6) 2011 when helping her grandmother outside. The patient denied missing any medications. The patient checked out with a cold at this time. The patient's settings were output=2. 25ma/frequency=25hz/pulse width=500usec/on time=30sec/off time=1. 8min/magnet output=2. 75ma/magnet frequency=30hz/magnet pulse width=500usec. The patient has an average of 8-10 seizures per month. The physician reported that they are going to simplify her medication regimen and that the patient understands that these changes could result in an increased seizure activity. Review of the clinic notes dated (b)(6) 2011 revealed that the patient's antiepileptic drug levels were low. The patient reported that she had not missed any doses but seemed confused about how to take the tegretol. Clinic notes dated (b)(6) 2011 revealed that the patient had several seizures back to back a few days prior and was transported to the emergency room by ambulance. The patient's settings were output=2. 25ma/frequency=25hz/pulse width=500usec/on time=30sec/off time=1. 8min/magnet output=2. 75ma/magnet frequency=30hz/magnet pulse width=500usec. A system diagnostics test was performed on (b)(6) 2011 which showed output=ok/lead impedance=ok/dcdc=2/eri=no. The physician reported that the patient might possibly have a battery replacement. A battery life calculation was performed which showed 0. 42 years until eri=yes. Although surgery is likely, it has not yet occurred. Good faith attempts for additional information from the physician have been to no avail thus far. When additional information is received, it will be reported.
 
Event Description
Additional information was received on (b)(6) 2011 when it was reported that the vns patient had their battery replaced for prophylactic reasons that day. The manufacturer's consultant reported that the patient had been experiencing an increase in seizures and had 14 seizures on the morning of (b)(6) 2011 while waiting for surgery. The consultant also reported that the patient has been at very high settings. The consultant also reported that the vns patient's neurologist has passed away and she is helping the patient find a new neurologist. The explanted generator was returned to the manufacturer for product analysis on (b)(6) 2011 which has not yet been completed.
 
Event Description
Additional information was received on (b)(6) 2011 when product analysis was completed on the explanted generator. Although the reported allegation of "increased seizures" cannot be evaluated in the product analysis laboratory setting, proper functionality of the pulse generator in its ability to provide appropriate programmed output currents can be verified. In the product analysis lab, the device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator's output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The pulse generator diagnostics were as expected for the programmed parameters. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications and there were no performance or any other type of adverse conditions found with the pulse generator.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2220442


Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 19, 2011, 01:22:11 AM
Event Date 01/01/2009
Event Type Malfunction
Event Description
Clinic notes were received for the patient reporting that they were having an increase in seizures in (b) (6) 2009. It was reported they had an increase in seizure frequency and continued daily seizures. It is unknown if the reported increase in seizures was above the patient's pre vns seizure rate. The patient's family member was not able to provide a quantitive amount of seizures. The patient was to be scheduled for possible battery replacement this summer and it was reported the patient passed away. See medwatch report number: 1644487-2009-01219.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1455252



Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 19, 2011, 01:23:12 AM
Event Date 01/01/2009
Event Type Malfunction
Event Description
Clinic notes were received for the patient reporting that they were having an increase in seizures in (b) (6) 2009. It was reported they had an increase in seizure frequency and continued daily seizures. It is unknown if the reported increase in seizures was above the patient's pre vns seizure rate. The patient's family member was not able to provide a quantitive amount of seizures. The patient was to be scheduled for possible battery replacement this summer and it was reported the patient passed away. See medwatch report number: 1644487-2009-01219.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1455252


Title: Re: Increase/worsening of seizures
Post by: dennis100 on December 19, 2011, 01:23:51 AM
Model Number 102
Event Date 04/27/2009
Event Type Injury Patient Outcome Required Intervention;
Event Description
It was reported that the pt was reporting an increase in seizures that is above her pre-vns baseline levels. Diagnostics performed were within normal limits and there was no eri-flag. The physician believes that the device is approaching eos since the pt has been at 3. 0ma since 2005. It was also reported by the pt that the magnet was not activating vns properly and electrical "discharges" were not at regular intervals. Review of clinic notes from neurologist's office indicated that the pt was experiencing frequent auras, but some were associated with her knee surgery that she had over the summer. He also noted that her recent seizures have not included her typical prodromal symptoms, usually nausea and lip smacking and there was no warning. A recent seizure was described when she was at the store, where she grabbed hold of the shopping cart and had a blank stare. The seizures was followed by headaches and later nausea and vomiting. The pt reports of having 1-2 of these seizures per day and possible some during her sleep. The pt also reports some "difficulty with breathing during sleep. " the vns was interrogated and reprogrammed at the appointment. Pulse width was increased from 250 to 500 microseconds. At a later appointment , the pt reported that she noticed increased intensity of vns discharges for a couple of days then it improved. She was also started on lyrica at that time and complained of dizziness and fatigue for a couple of days. The pt indicated that she awo