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Author Topic: Increase/Worsening of Seizures  (Read 70839 times)
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dennis100
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« on: November 23, 2011, 03:19:03 PM »

<a href="http://www.youtube.com/watch?v=gRQoclwjTsY" target="_blank">http://www.youtube.com/watch?v=gRQoclwjTsY</a>


1997 FDA CDHR Neurolocal Devices Panel

DR. COSTELLO: Good afternoon, Dr. Wilkinson and members of the panel. This afternoon, I will be discussing issues regarding the safety and effectiveness of the vagus nerve stimulation device......................One-third of the patients had some type of an increase in seizures, with 17 percent having greater than a 25 percent increase.................This slide shows each of the studies and the percent seizure increase. As you can see, in each of the studies, there were patients who had greater than a 100 percent increase. In the E05 study, the range went up to a 234 percent increase, while in the E04 study, it went even higher, to a 680 percent maximum range.
 
pg. 125
http://www.fda.gov/ohrms/dockets/AC/97/transcpt/3299t1.pdf


The next issue which I would like to address is the long-term data. As can be seen in the extension phase of the XE5 study, here are the results of the randomized, controlled trial and then followup at 4, 6 and 9 months. Both the mean percent change and the median percent change during the extension phase showed approximately a 30 percent seizure reduction for these patients. However, this data is confounded by the fact that the patients were changing their medications during this period.

Similarly, despite optimal antiepileptic drug therapy, only 20 percent of the patients in the extension phase, using a last visit carried forward analysis, had 50 percent or greater reduction in seizures. One-third of the patients had some type of an increase in seizures, with 17 percent having greater than a 25 percent increase.

pg. 130
http://www.fda.gov/ohrms/dockets/AC/97/transcpt/3299t1.pdf
 
______________________________________________________


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
« Last Edit: March 30, 2013, 07:07:21 AM by dennis100 » Logged
dennis100
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« Reply #1 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
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dennis100
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« Reply #2 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

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dennis100
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« Reply #3 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

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dennis100
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« Reply #4 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
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dennis100
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« Reply #5 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
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dennis100
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« Reply #6 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
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dennis100
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« Reply #7 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

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dennis100
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« Reply #8 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

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dennis100
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« Reply #9 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.


« Last Edit: November 23, 2011, 03:29:45 PM by dennis100 » Logged
dennis100
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« Reply #10 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
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dennis100
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« Reply #11 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
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dennis100
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« Reply #12 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

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dennis100
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« Reply #13 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
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dennis100
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« Reply #14 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
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dennis100
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« Reply #15 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

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dennis100
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« Reply #16 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

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dennis100
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« Reply #17 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

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« Reply #18 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

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« Reply #19 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

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dennis100
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« Reply #20 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

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« Reply #21 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

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« Reply #22 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

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« Reply #23 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

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« Reply #24 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

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« Reply #25 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

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dennis100
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« Reply #26 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

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dennis100
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« Reply #27 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

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dennis100
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« Reply #28 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

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dennis100
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« Reply #29 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
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