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Author Topic: Increase/Worsening of Seizures  (Read 661492 times)
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dennis100
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« Reply #3990 on: September 11, 2018, 03:09:42 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 02/23/2018
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported that the patient was experiencing an increase in seizures. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7343775
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dennis100
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« Reply #3991 on: September 11, 2018, 03:10:30 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/11/2013
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported by a distributor that a patient¿s vns was explanted per the family¿s decision as the ¿patient continued with seizures despite control of programming¿. When making adjustments to the parameters the seizures were reported to have increased. The lead impedance was not known. The explanted devices have not been received by the manufacturer to-date.

Manufacturer Narrative

Event Description
The explanted generator was received and analysis was completed. The device output signal was monitored for more than 24 hours, 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 diagnostics were as expected for the programmed parameters. Electrical evaluation showed that the generator performed according to functional specifications. The battery measured 3. 016 volts and was not in a depleted condition. The downloaded data revealed that 13. 144% of the battery had been consumed. 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=7274988
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dennis100
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« Reply #3992 on: September 13, 2018, 02:31:54 AM »

Model Number 102
Event Date 04/06/2010
Event Type  Injury   
Event Description
It was reported that a vns pt experienced an increase in seizures due to unk reason. Further info from the treating nurse indicated medications were increased and a battery life calculation was requested. The results of the battery life calculation indicated the pt's device had not reached end of service. Recent diagnostics indicated the device to be working within normal limits. Follow-up with the treating nurse through a company rep indicated that it is unk as to what caused the pt's increase in seizure activity as it was above pre-vns level. Furthermore, other factors that could have contributed to the pt's increase were possible generic medication switch.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1667281
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dennis100
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« Reply #3993 on: September 13, 2018, 02:32:26 AM »

Model Number 101
Event Date 07/01/2010
Event Type  Malfunction   
Event Description
It was initially reported by the physician that the pt recently showed increase in seizures. Physician was not sure why the pt showed increase in seizures all of a sudden. No additional info was provided. Good faith attempts to obtain additional info has been unsuccessful till date. The cause of event is unk at the moment.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1823575
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dennis100
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« Reply #3994 on: September 14, 2018, 08:30:57 AM »

Model Number 102
Event Date 01/01/2011
Event Type  Injury   
Event Description
Product analysis has been completed on the explanted generator and no anomalies were noted. The generator performed according to functional specifications.

Event Description
Additional information received revealed that the patient underwent generator revision surgery where the generator was explanted and replaced prophylactically. The explanted generator has been returned to the manufacturer for analysis; however, the analysis has not been completed at this time.

Manufacturer Narrative
Analysis of programming/device diagnostic history performed.

Event Description
It was reported via clinic notes dated (b)(6) 2011 that the patient has had seven generalized tonic-clonic seizures this year when typically, the patient will have one or two a year. The physician adjusted the patient's device settings by increasing the pulse width to 500 usec and increased the duty cycle from 16% to 25%. The magnet pulse width was also adjusted however no details surrounding that adjustment were provided. The patient will be referred for generator replacement surgery as she has been implanted with the same generator for five years.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2327437&pc=LYJ
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dennis100
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« Reply #3995 on: September 15, 2018, 02:08:23 AM »

Model Number 102
Event Date 10/01/2010
Event Type  Malfunction   
Event Description
It was reported that the pt was experiencing an increase in seizures. X-rays were received and reviewed by the mfr. Upon review, no anomalies were noted with the device. Attempts for further info have been unsuccessful to date.

Manufacturer Narrative
Mfr reviewed x-rays of implanted device. X-rays reviewed by the mfr, no anomalies visualized.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1898607
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dennis100
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« Reply #3996 on: September 17, 2018, 11:59:20 AM »

Model Number 102R
Event Date 01/01/2010
Event Type  Death   
Event Description
Additional information was received from the patient's treating physician indicating that the patient died in (b)(6) 2004 and the death was believed to be unrelated to vns. No further information was available from the physician.

Manufacturer Narrative

Event Description
It was reported through a scientific article that a vns patient died a sudden unexpected death in epilepsy after 9 years of successful vns treatment. About 4 months prior to death, the patient had fallen on ice and subsequently experienced a worsening of her seizure control. At 3. 5 months later, the vns was explanted and a new one was implanted. Eleven days after the operation, the patient was found dead. Investigations post mortem did not reveal any problems with the new stimulator, but the cable was twisted. At the moment, the cause of death and the relationship to vns therapy is unknown. Good faith attempts to obtain further information regarding the event have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2373884
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dennis100
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« Reply #3997 on: September 23, 2018, 04:52:57 AM »

Event Date 01/01/2004
Event Type  Injury   
Event Description
Reporter indicated that the pt was getting lead and generator explanted in 2009. He had an increase in seizures when device was implanted and device was turned off in 04. Attempts for further info and product return are pending.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1321658
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dennis100
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« Reply #3998 on: September 26, 2018, 05:58:11 AM »

Model Number 101
Event Date 01/01/2008
Event Type  Malfunction   
Event Description
Reporter indicated that the pt was experiencing an increase in seizures, and seizure intensity. Attempts for more info have been unsuccessfully to date. The cause and relationship between the increase in seizures and increased seizure intensity, is unk.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1418627
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dennis100
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« Reply #3999 on: October 03, 2018, 07:23:56 AM »

Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/01/2017
Event Type  Death   
Manufacturer Narrative

Event Description
The abstract of a research article was received. The abstract discussed the outcomes in treatment of adults with lennox-gastaut syndrome. Within the article, it was noted 4 patients who were implanted with vns did not experience improved seizure control, and experienced worsening seizures. It was also noted that 1 patient implanted with vns passed away during the first encounter. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7797264
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dennis100
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« Reply #4000 on: October 04, 2018, 04:24:33 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 03/15/2018
Event Type  Injury   
Manufacturer Narrative

Event Description
A patient experienced increased seizure activity, including a 25-minute seizure that was unusual for him. The prolonged seizure required er evaluation and increased seizure medication. The increase in seizures prompted a semi-urgent follow-up visit for vns evaluation. Upon interrogation of the vns, the physician observed an intensified follow-up indicator on the patient's generator. The generator showed no warning messages upon interrogation at a clinic visit 4 months prior. The physician believed that the increased seizure activity was related to the low battery status of the generator. The patient underwent generator replacement surgery. The explanted device has not been returned to the manufacturer to date. No additional relevant information has been received to date.
 
Event Description
Preoperative diagnostics from the date of explant were within the normal limits, per the company representative who attended the surgery. Analysis was approved for the returned generator. The final data was downloaded from the generator and reviewed. No anomalies were identified in the programming data. The device output signal was monitored for more than 24 hours, while the pulse generator was placed in a simulated body temperature environment. The pulse generator showed no signs of variation in the output signal and demonstrated the expected level of output current. The pulse generator diagnostics were as expected for the programmed parameters. There were no performance or any other type of adverse conditions found with the pulse generator.
 
Event Description
The explanted generator was received for analysis, but product analysis has not been approved for the device to date. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7531403
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dennis100
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« Reply #4001 on: October 05, 2018, 01:26:34 PM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 08/17/2018
Event Type  Injury   
Event Description
It was reported that the patient was experiencing an increase in seizures. The patient was referred for vns replacement surgery. No relevant surgical intervention is known to have occurred to date. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7900075
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dennis100
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« Reply #4002 on: October 05, 2018, 01:27:13 PM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Type  Malfunction   
Manufacturer Narrative
Event Description
It was reported that the patient had an increase in seizures. The patient had an eeg and was to follow up with the physician. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7918532
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dennis100
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« Reply #4003 on: October 06, 2018, 06:44:40 AM »

Model Number 1000
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 08/31/2018
Event Type  Malfunction   
Event Description
It was reported that the patient's experienced an increase in seizures hours after surgery. The vns was not programmed on at the time as it was a new implant. Follow up with the surgeon revealed that he was unsure as to the cause of the increase in seizures, but it may have been the result of an infection experienced by the patient following surgery. It was stated that the patient developed a colon infection (clostridium difficile colitis). The surgeon stated that it was unrelated to vns, but that it did occur right after the surgery. It was stated that the patient had a fever and diarrhea the night after surgery. It was reported that antibiotics can cause the infection, but it was strange for it to happen immediately. The surgery was reported as routine with no excessive manipulation of the vagus nerve. The patient was fine post-op and went home. The patient later experienced the symptoms. The increase in seizures was above the pre-vns baseline. A review of device history records revealed that the generator and lead were sterilized and passed quality control inspection prior to distribution. No additional relevant information has been received to date.

Manufacturer Narrative
Device evaluation is not necessary because the reported events have been determined as not related to vns therapy.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7907010
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dennis100
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« Reply #4004 on: October 06, 2018, 06:45:14 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 07/30/2018
Event Type  Injury   
Event Description
It was reported that the patient was having an increased seizures which was described as a burst of seizures. The patient was referred for vns replacement due to the seizures. No relevant surgical intervention is known to have occurred to date. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7855613
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dennis100
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« Reply #4005 on: October 06, 2018, 06:45:45 AM »

Model Number 102
Device Problem Adverse Event Without Identified Device or Use Problem
Event Type  Injury   
Event Description
It was reported via clinic notes that the patient had an increase in seizures. It was questioned if the vns battery could have attributed to this. The patient was referred for generator replacement to address this. No surgical intervention is known to have occurred to date. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7918958
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dennis100
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« Reply #4006 on: October 06, 2018, 06:46:19 AM »

Model Number 102
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/01/2009
Event Type  Malfunction   
Event Description
It was reported that the patient believed she had more seizures with the vns turned on. She stated that she was currently having 30-40 seizures a month, which was how many she had when the vns was turned on. It was noted that the physician ordered an emu to check the seizure count as the patient had "an extensive psychological background". No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7892128
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dennis100
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« Reply #4007 on: October 06, 2018, 06:46:49 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 08/31/2018
Event Type  Injury   
Manufacturer Narrative
 
Event Description
Clinic notes were received indicating the patient had an increase in seizure frequency. The notes indicated the [stimulator] stopped for unclear reason. The patient was reported to have increased lethargy some difficulty in speech and also seizures. He was admitted to the hospital. Additional relevant information has not been received to-date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7910279
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dennis100
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« Reply #4008 on: October 06, 2018, 06:47:18 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Type  Injury   
Manufacturer Narrative

Event Description
It was stated that the patient had been doing well with vns, but was having an increase in seizure clusters. Newer devices were discussed and the physician believed the patient could benefit from upgrade to sentiva. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7892216
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dennis100
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« Reply #4009 on: October 06, 2018, 06:47:46 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 10/08/2015
Event Type  Malfunction   
Manufacturer Narrative
 
Event Description
It was reported by the patient's partner that the patient had had too many grand mals since implant and that his seizures had steadily gotten worse. He indicated that the patient had had around 20 grand mal seizures since having the vns implanted and had many aura type seizures daily. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7883304
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dennis100
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« Reply #4010 on: October 06, 2018, 06:48:17 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 09/01/2018
Event Type  Malfunction   
Event Description
It was reported that the patient was having an increase in seizures and the magnet was not stopping the seizures as it used to. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7914706
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dennis100
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« Reply #4011 on: October 06, 2018, 06:48:46 AM »

Model Number 104
Device Problem Adverse Event Without Identified Device or Use Problem
Event Type  Injury   
Manufacturer Narrative
Event Description
It was reported by the patient that she believes she needs a vns replacement due to her seizures getting worse and having changed. The patient stated she was in the icu for 4 days with seizures. The patient had not seen a neurologist and was looking for a recommendation to see one however no neurologist appointment is known to have occurred. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7916429
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dennis100
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« Reply #4012 on: October 06, 2018, 06:49:19 AM »

Model Number 102
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/01/2017
Event Type  Injury   
Manufacturer Narrative
Event Description
It was reported that the patient's seizures had increased since sometime in 2017. It was reported that the patient's medications were changed after seeing another neurologist in 2015 and the patient's current nurse practitioner was unsure if the increased seizures was associated with a medication change or with the depletion of the vns battery. A battery estimation was calculated and did not indicate the device's battery was depleted during the time in increased seizures began. The patient was referred for replacement surgery. No relevant surgical intervention is known to have occurred to date. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7900319
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dennis100
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« Reply #4013 on: October 06, 2018, 06:49:49 AM »

Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/01/2018
Event Type  Malfunction   
Manufacturer Narrative
Event Description
It was reported via social media comment by the patient that the patient's vns did not stop his seizures. The patient stated that the seizures continued as well as increasing in frequency and strength. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7877445
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dennis100
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« Reply #4014 on: October 06, 2018, 06:50:26 AM »

Model Number 1000
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 08/21/2018
Event Type  Malfunction   
Event Description
It was reported that the patient was having an increase in seizures following a recent settings change. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7884895
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dennis100
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« Reply #4015 on: October 06, 2018, 06:50:58 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 08/30/2018
Event Type  Injury   
Manufacturer Narrative
Event Description
It was reported from a patient's wife that the patient's seizures are "worse than ever". The patient was scheduled for surgical consult. No surgical intervention has been taken to date. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7908686
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dennis100
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« Reply #4016 on: October 06, 2018, 06:51:35 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/01/2015
Event Type  Malfunction   
Event Description
It was reported by the patient's mother that this vns patient listed above experienced efficacy with the vns for the first year, but since, the patient has experienced an increase in seizures. It was stated that the patient has been to multiple neurologists and has tried nearly every medication on the market. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7920077
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dennis100
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« Reply #4017 on: October 06, 2018, 06:52:16 AM »

Model Number 1000
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 04/01/2018
Event Type  Injury   
Event Description
It was reported that after the vns implantation, the patient was experiencing an increase in seizures, intensity, and duration with a longer postictal phase. The patient had been hospitalized due to seizures and the patient underwent 23 hours of observation at one point as a result. The physician's office was unable to provide any assessment on the seizures relation to vns as they did not have any hospital notes. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7876733
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« Reply #4018 on: October 07, 2018, 03:32:30 AM »

Model Number 102
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 12/13/2006
Event Type  Injury   
Event Description
It was reported via clinic notes that the patient's vns was disabled due to worsening seizures after implant. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7343880
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« Reply #4019 on: October 09, 2018, 01:27:58 PM »

Model Number 103
Event Date 01/27/2012
Event Type  Injury   
Event Description
Clinic notes were received on (b)(6) 2012 from, a physician's office. The notes covered the patient's physician visit from (b)(6) 2011 to (b)(6) 2012. The patient was implanted on (b)(6) 2011, at which time the device was not programmed on. On (b)(6) 2011, notes reported pain at the surgical site, hoarse voice, and "multiple grand mal seizures after vns. " the vns incision lines looked good, were both healing well, without tenderness. The neck incision had surrounding swelling. On (b)(6) 2012, notes state that the patient's hoarse voice was gone, there was no more pain at the vns site, and no change in frequency. The notes indicate that the patient's device was turned on, and the patient did not feel anything. No settings are provided for this date, and initial interrogation at the next appointment indicates normal mode and magnet output currents were 0 ma. On (b)(6) 2012, the patient reported an increase in seizures and duration, along with aggression. The notes report that the magnet did seem to stop the seizures and make them shorter; however, settings from this date indicate that the device was programmed off until this appointment. The patient experienced painful magnet mode stimulation for the first magnet activation. On (b)(6) 2012, it was stated that the patient felt he had an upper respiratory infection the previous week. The patient turned during sleep and "felt spinal cord electricity," a lack of consciousness for 30 minutes, and then numbness throughout his head, which continued. There was now a change in seizures: the patient had a warning and then an out of body experience. He was unable to use the magnet during this time. The patient's aggression was reported to be less, he did not have any more headaches, but he did have neck pain. On (b)(6) 2012, notes reported that the seizures did decreased but have recently reoccurred. The patient occasionally coughed with vns but had no serious ill effects. The patient did experience coughing and choking during magnet stimulation; however, the magnet did abort seizures well. The patient's vns was adjusted, and the physician ensured that the patient tolerated both normal mode and magnet stimulation. On (b)(6) 2012, the patient was seen for increased blood pressure and a check of the patient's vns after the patient held a shocking dog collar while the collar was charging. The patient's vns settings were altered. This event is captured in mfr. Report # 1644487-2012-01066. On (b)(6) 2012, notes report that the patient was having the same amount of seizures (4/day) and no issues since turning the stimulator back on from the collar incident. On this date, the patient's settings were adjusted. On (b)(6) 2012, the patient was seen again for marked aggression, agitation, and an increase in grand mal seizures since the adjusted settings the previous day. The magnet did not seem to stop the seizures. The patient's mother taped the magnet over the patient's vns to disable the device, and all symptoms stopped. The patient's settings were reduced to (b)(6) 2012 settings. On (b)(6) 2012, the patient was reported to have a bad mood, irritable, snapping, and having more seizures. He was saying things he wouldn't have in the past and demonstrating almost manic-depressive type behavior. The patient became violent, hit his parents, screamed, held his head, demonstrated symptoms like a grand mal seizure, and later bit his finger. The patient was not able to perceive normal mode or magnet stimulation. The patient's mother felt that things were going well with vns at first, but felt as though the seizures were never really controlled. The patient's normal mode output current was programmed off, and the magnet was programmed to a higher output current that resulted in a cough lasting less than 5 seconds. Follow up with the nurse practitioner revealed the following information: the patient's increase in seizures was below his pre-vns baseline. The patient was treated by his primary care physician for the upper respiratory infection; however, the nurse practitioner did not think that the infection was related to vns. When asked about the change in seizure reported on (b)(6) 2012, no additional information regarding the change in seizures was available; however, the change was attributed to anxiety. The patient's anxiety was caused by vns: the presence of the device and the surgery. The nurse practitioner believes that the vns causes the patient anxiety. The anxiety, in turn, propagates more seizures. The patient was placed on medication to assist with the anxiety and sleep. There are discrepancies between the settings from appointment-to-appointment that may be due to recording errors. Attempts to obtain the physician's flashcard to review the patient's complete programming history are underway.
 
Manufacturer Narrative

Event Description
On (b)(4) 2012, a copy of the physician's flashcard was received. The patient's programming history was reviewed. The programming history provided spanned (b)(6), 2012.
 
Manufacturer Narrative
Analysis of programming history. Relevant tests/laboratory data, including dates, corrected data: previously submitted mdr reported incorrect settings for (b)(6) 2012, (b)(6) 2012, (b)(6) 2012, (b)(6) 2012, and (b)(6) 2012. Additional information was received providing correct settings for these dates. This report is being submitted to correct this information.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2584000
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