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Author Topic: Increase/Worsening of Seizures  (Read 890704 times)
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dennis100
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« Reply #4140 on: March 09, 2019, 03:50:12 AM »

Model Number 105
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/18/2019
Event Type  Injury   
Event Description
It was reported the patient's vns therapy duty cycle was increased and medication adjusted to compensate for an increase in seizures the patient had experienced recently. The diagnostics for the patient were within normal limits. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8332080
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dennis100
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« Reply #4141 on: March 09, 2019, 03:50:57 AM »

Model Number 105
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/28/2019
Event Type  Malfunction   
Event Description
It was reported that the patient could no longer feel their device stimulation and that the patient experienced an increase in seizure frequency that caused the staff at the patient's nursing home to believe the vns was no longer working. The patient's neurologist indicated that the patient goes through "ups and downs" with seizure frequency and has potential non-epileptic seizures so the physician was unable to tell if the patient's current state was an increase in seizures. The neurologist indicated that the patient's vns settings had been consistent, and that the increase in seizures was likely not related to a change in vns settings. The neurologist indicated the patient's medications had recently changed and the patient had moved to a nursing home in (b)(6) of 2018. The patient's nursing home indicated that they wanted the patient to be replaced prophylactically for the responsive stimulation feature. No known relevant surgical intervention has occurred to date. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8362978
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dennis100
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« Reply #4142 on: March 09, 2019, 03:51:52 AM »

Model Number 102
Device Problem Adverse Event Without Identified Device or Use Problem
Event Type  Malfunction   
Event Description
It was reported that a patient was experiencing an increase in seizures, and his device could not be interrogated at the office visit. A follow-up appointment was being scheduled to have the local representative help check the device prior to referral for replacement. It was confirmed that the physician's tablet was able to properly function with the company representative's demo generators. A battery life calculation was performed and based on the programming data available to date, it was estimated that the device had 3. 4 years remaining until near end of service condition. No further relevant information was received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8364049
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dennis100
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« Reply #4143 on: March 09, 2019, 03:52:29 AM »

Model Number 102
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 10/18/2006
Event Type  Malfunction   
Event Description
Clinic notes were received indicating that the patient had an "acceleration of his seizures", which was believed to have been a result of the physical stress of having a vagal nerve stimulator implanted. Diagnostics were tested and shown to be within normal limits. The device was not turned on until this visit. No further, relevant information was received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8371555
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dennis100
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« Reply #4144 on: March 09, 2019, 03:53:01 AM »

Model Number 102
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 07/31/2013
Event Type  Malfunction   
Event Description
It was reported in clinic notes received for the patient¿s replacement that the patient had an increase in seizures. The programming history was reviewed and no anomalies at the time of the event were seen. No additional information is available.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8333289
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dennis100
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« Reply #4145 on: March 09, 2019, 03:53:35 AM »

Model Number 1000
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 09/07/2018
Event Type  Malfunction   
Event Description
It was reported by the patient¿s mother that the patient's vns was not working as the patient has had an increase in seizures since the vns was implanted. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8312416
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dennis100
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« Reply #4146 on: March 09, 2019, 03:54:09 AM »

Model Number 1000
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 04/26/2018
Event Type  Injury   
Event Description
It was reported that the patient has had an increase in seizures following their vns replacement. The physician did not know the cause of the increase in seizures, and the patient had been titrated to their previous generator settings. The increase in seizures was above pre-vns baseline frequency. The patient¿s current settings and diagnostics are unknown, although the last diagnostic test was reported to be within normal limits. No surgical intervention has occurred to date. No additional information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8330976
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dennis100
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« Reply #4147 on: March 09, 2019, 03:54:47 AM »

Model Number 1000
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/03/2019
Event Type  Injury   
Event Description
Patient was experiencing an increase in intensity of seizures. It was reported that the patient was experiencing at least one daily seizure that was strong and more intense compared to the past. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8297703
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dennis100
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« Reply #4148 on: March 10, 2019, 02:33:45 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 12/28/2018
Event Type  Malfunction   
Event Description
Patient was reported to be referred to generator replacement due to low battery "unable to interrogate generator" and "significant increase in seizure frequency from baseline. " further information was received that the patient was able to be successfully interrogated and that the device "showed no issues. " the replacement was stated to be postponed until the battery was "closer to eos. " no further information related to the increase in seizures was provided. No known surgical intervention has occurred to date. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8330625
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dennis100
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« Reply #4149 on: March 12, 2019, 03:59:08 AM »

Model Number 104
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 08/01/2015
Event Type  Malfunction   
Event Description
It was reported that a patient had recently experienced an increase in seizures. The patient believed that the increase in seizures was due to her vns battery being "dead. " attempts for further information were unsuccessful to date.
 
Event Description
The patient had prophylactic generator replacement surgery on (b)(6) 2015. Diagnostics showed that the device was functioning properly. The explanting facility does not return product without written patient consent. Therefore, the generator was not available for return.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5074301
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dennis100
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« Reply #4150 on: March 20, 2019, 11:26:10 AM »

Model Number 102
Device Problems Generator; Vibration
Event Date 10/05/2015
Event Type  Injury   
Event Description
It was reported the patient is experiencing constant vibration at her generator site and alleges the vns has stopped controlling her seizures. It was noted the patient had a new implant on (b)(6) 2014 and was relatively well controlled prior to reporting the vibration and lack of efficacy. It was later reported the patient self-referred herself to the surgeon but the patient did not see her neurologist. The patient was reporting vibration with her generator but the surgeon didn't find anything wrong. It was reported the patient is having an increased in seizures and the magnet doesn't work anymore like it used to. It is unknown if the increase in seizures is below, at, or above pre-vns levels. It was reported that diagnostics were run and everything was fine. The surgeon wanted to change out the patient's generator. Surgery is expected; however, no surgical interventions have occurred to date. Attempts for additional relevant information have been unsuccessful to date.
 
Event Description
It was reported the patient had her generator replaced on (b)(6) 2015 as the device was unable to be interrogated due to battery depletion. Product analysis for the returned generator was completed on (b)(6) 2015. The battery life calculation estimate was made using the "as received" parameters which resulted in approximately 7 years remaining until near end of service (neos) = yes. During product analysis, the generator's 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 generator's output signal and demonstrated the device provided the expected level of output current for the entire monitoring period. Magnet activations were performed during the output monitoring and the generator demonstrated the appropriate magnet output for the programmed settings. Diagnostics were performed and the results were as expected for the programmed parameters. Additionally, an electrical evaluation showed the generator performed according to functional specifications. There were no performance or any other type of adverse conditions found with the generator. Additional information was received which showed the surgeon's serial cable was the cause of the reported failure to program, not a depleted generator battery. The failure of the surgeon's serial cable has been captured in mfr. Report # 16444487-2015-06478. Attempts for additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5225237
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dennis100
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« Reply #4151 on: March 28, 2019, 08:33:37 AM »

Model Number 106
Event Date 01/05/2016
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported by the patient's mother that there was bruising around the incision site after the vns generator and lead were implanted. An additional phone call was later placed by the patient's mother. The patient's mother explained that the patient initially had a decrease in seizures right after surgery, from about 30 seizures/day down to about 5 seizures/day until (b)(6) 2016. On (b)(6) 2016, the patient had approximately 30 seizures, on (b)(6) 2016 the patient had greater than 50 seizures, and on (b)(6) 2016 the patient had nearly back to back seizures. The patient was taken to the er and the patient's following neurologist came down to the er and programmed the patient's vns on. The patient tolerated the stimulations. It was also reported the patient's mother had used the vns magnet to activate the vns several times on (b)(6) 2016 and noted the patient had done ok with the magnet stimulations. However, it was noted that the patient had some blotchiness on her face, neck, and chest but the cause of the blotchiness was unknown. The blotchiness was noted to come and go with seizures, but not all seizures. The dhrs for both the lead and the generator were reviewed and confirmed the devices passed all testing and were sterilized prior to distribution. Attempts for additional relevant information have been unsuccessful to date.
 
Manufacturer Narrative
Adverse event and/or product problem; corrected data: this information was inadvertently reported incorrectly on the initial mfr. Report. Outcomes attributed to adverse event; corrected data: this information was inadvertently reported incorrectly on the initial mfr. Report. Type of reportable event; corrected data: this information was inadvertently reported incorrectly on the initial mfr. Report.
 
Event Description
Additional information was received showing the patient was actually hospitalized for 2 weeks, due to the increased seizures, beginning on (b)(6) 2016. It was also noted the vns magnet was used to temporarily disable to the device; however, it is currently unknown why this disablement occurred. Attempts for additional relevant information have been unsuccessful to date.
 
Event Description
Additional information was received from the physician who stated the bruising, increase in seizures, and blotchiness were not related to vns, and the office has since made titrations with no recurrence of the issues.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5446622
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dennis100
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« Reply #4152 on: March 29, 2019, 08:31:11 AM »

Model Number 103
Event Date 01/01/2016
Event Type  Injury   
Manufacturer Narrative

Event Description
Notes were received on (b)(6) 2016 for patient referral for replacement. The cover sheet for referral states that the patient is referred for m106 device since the m103 battery is at end of service. The form states patient is having an increase in seizures since the vns is not working. Updates from the physician's office state that the patient was seen on (b)(6) 2016 and the battery was eos-yes. The patient has had an increase in seizures and they feel it is related to a depleted battery. They do not know if the seizures are below, back to, or above pre-vns baseline levels. The patient underwent generator replacement due to end of service on (b)(6) 2016. However, the implant card received did state that the surgery was prophylactic as the device was ifi-yes. Generator received for analysis on 02/02/2016 and analysis is underway but has not been completed to date.
 
Event Description
Product analysis for the generator was completed and approved on 02/25/2016. 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 battery, as measured during completion of test parameter of the final electrical test, shows an ifi=no condition. 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=5417115
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dennis100
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« Reply #4153 on: March 30, 2019, 02:41:47 AM »

Device Problem Adverse Event Without Identified Device or Use Problem
Event Type  Injury   
Event Description
It was reported that this patient almost died after having the vns implanted, and spent almost an entire year in the hospital due to the vns, and was put on life support. It was stated that the patient is now permanently disabled because of it. The patient had never before been treated for depression, and the patient had the device implanted to treat her seizures, but not only did the device make her seizures become so bad they almost killed her, but it caused her to become severely depressed, which is something she had never been diagnosed with before. It was stated that the family has suffered great tragedy because of the device. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7472454
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dennis100
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« Reply #4154 on: April 05, 2019, 01:52:22 AM »

Model Number 103
Event Date 05/25/2016
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that a vns patient, who is implanted since (b)(6) 2016, was not comfortable with vns. It was reported that when the physician tried to increase the output current from 0. 25ma to 0. 5ma, the patient had pain, suffocation, not really comfortable and crying. It was reported that the modification of the device parameters did not solve the issue. The event was described by the physician as serious ; the physician was looking to switch the device off and definitely explant it, but she finally decided to let it turned on at 0. 25ma and see if there will be any improvement. It was reported that the device was tested on 05/25/2016 and system diagnostics returned impedance results within normal limits. It was reported that in beginning (b)(6) 2016, the device was turned off due to big seizures (high intensity than before vns implantation) but this was not related to vns at all. The device was then switched back on 1 month later, at the output current of 0. 25ma. Review of manufacturing records confirmed all tests passed for the generator and lead prior to distribution. No additional information was provided to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5722569
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« Reply #4155 on: April 05, 2019, 10:34:44 PM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 07/17/2018
Event Type  Injury   
Event Description
It was reported that the patient experienced an increase in seizure frequency. The patient's physician was unable to assess the causation of the patient's increase in seizure frequency and there were no known external factors that contributed to the increased frequency. The patient was referred for generator replacement. No known relevant surgical intervention has occurred to date. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8463783
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« Reply #4156 on: April 05, 2019, 10:35:15 PM »

Model Number 1000
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 02/28/2019
Event Type  Malfunction   
Event Description
It was reported that the patient had not experienced any changes in seizure frequency since their generator replacement surgery. The patient indicated that they "may even be worse" referring to their seizure frequency. Multiple attempts for additional information were made; however, no further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8458409
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« Reply #4157 on: April 05, 2019, 10:35:52 PM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 03/06/2019
Event Type  Malfunction   
Event Description
It was reported that the patient recently had an episode of increased seizures and went into status for 50 minutes. No additional information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8461243
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« Reply #4158 on: April 05, 2019, 10:36:22 PM »

Model Number 1000
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/05/2019
Event Type  Malfunction   
Event Description
It was reported that the patient tripped over a heater cord in the kitchen and hit her head, but did not fall on her vns site. After this, the patient began having headaches that have not resolved. She saw her neurologist who directed her to see her primary care physician who had her get a ct scan. She had not heard back and was beginning to have seizures. The patient also reported pain at the vns site. She reported 2-3 seizures since the fall, which was noted to be an increase. It was stated that she followed with a physician's office who stated her chest incision site looked fine and was healing normally. No diagnostics were performed since the fall. No additional, relevant information was received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8382679
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« Reply #4159 on: April 05, 2019, 10:36:59 PM »

Model Number 105
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/25/2019
Event Type  Injury   
Event Description
It was reported in clinic notes received for the patient¿s replacement surgery that the patient was not doing well. The patient had an increase in seizures. Programming history was reviewed. No anomalies were seen. Surgery is likely but has not occurred to date. No further information is available.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8387586
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« Reply #4160 on: April 05, 2019, 10:37:35 PM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 02/07/2019
Event Type  Injury   
Event Description
It was reported that the patient needed an mri for a recent increase in seizures. The patient was admitted to the hospital recently for the seizures. Further information was received that the device was disabled for an mri and turned back on to previous settings after. Diagnostics were performed and impedance was ok. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8386373
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« Reply #4161 on: April 05, 2019, 10:38:16 PM »

Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 02/13/2019
Event Type  Injury   
Event Description
It was reported from a mother of a potential vns patient who stated that she spoke with several people who told her not to get vns. She says her daughter's case worker's child has the vns and that it made the child's seizures worse. No further information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8394963
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« Reply #4162 on: April 06, 2019, 02:53:53 AM »

Model Number 104
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 04/11/2018
Event Type  Injury   
Event Description
It was reported by the neurologist that after the patient was replaced in (b)(6) 2018 they were having seizures worse than before. When the patient was seen in office, the device had normal impedance and battery life. The patient was referred for replacement. Programming history was reviewed for the generator. No anomalies were seen. The device history record was reviewed for the generator, and it passed all specifications prior to distribution. No relevant surgical intervention has occurred to date. No other relevant information is known.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8429193
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« Reply #4163 on: April 07, 2019, 04:00:59 AM »

Model Number 105
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/13/2019
Event Type  Injury   
Event Description
It was reported that the patient experienced an increase in seizure frequency. The patient's physician reported that the vns magnet did not suppress one of the patient's seizures, due to the generator battery "dimming" likely referring to the generator battery being lower. The battery life was provided as having 25-50% battery life remaining. The patient was referred for generator replacement. No known relevant surgical intervention has occurred to date. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8423245
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« Reply #4164 on: April 07, 2019, 04:01:29 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 11/15/2018
Event Type  Malfunction   
Event Description
It was reported that the patient's mother called the neurologist's office reporting an increase in seizures. The report of the increased seizures was relayed to the physician; and therefore, the physician does not have an assessment on this case. No surgical intervention has occurred and no other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8412767
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« Reply #4165 on: April 07, 2019, 04:02:03 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 12/01/2018
Event Type  Malfunction   
Event Description
It was reported that the patient had a fall from a seizure in (b)(6) 2018 and ever since has had an increase in seizures from 1-2 seizures a month to about 1-2 seizures a week. It was stated that there had not been any changes to medications and to the mother's knowledge, no missed medication dosage. The vns output settings for normal, magnet, and autostimulation modes were increased to try and help with the increase in seizures. The patient's generator was interrogated and system diagnostics were performed indicating that the device was functioning as intended. No additional, relevant information was received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8425944
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« Reply #4166 on: April 07, 2019, 04:03:54 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 02/22/2019
Event Type  Malfunction   
Event Description
It was reported that the patient was experiencing a lot of seizures. The patient had recently changed neurologists and their current neurologist was unsure if the patient's seizure rate had increased since they had just began seeing the patient. The physician did not have an assessment on the relationship between the patient's potential increase in seizure frequency and the vns. The physician indicated that some external factors that may have contributed to the seizure frequency were antibiotics, increased ammonia, and low depakote levels. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8432402
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« Reply #4167 on: April 07, 2019, 04:04:34 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 02/19/2019
Event Type  Malfunction   
Event Description
It was reported that the patient has had an increase in seizures. The nurse was unable to assess if the patient¿s increase in seizures was worse than their pre-vns baseline. Programming history was reviewed for the generator. No anomalies were seen. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8432456
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« Reply #4168 on: April 07, 2019, 04:05:10 AM »

Model Number 1000
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 02/24/2019
Event Type  Malfunction   
Event Description
It was reported that the patient was in the hospital suffering from increased seizures and wanted to have their vns checked. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8439305
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« Reply #4169 on: April 07, 2019, 04:06:50 AM »

Model Number 102
Device Problem Adverse Event Without Identified Device or Use Problem
Event Type  Malfunction   
Event Description
It was reported that a patient was experiencing an increase in seizures above pre-vns baseline levels for the past 2-3 months. Programming history was reviewed and found that the last diagnostics were from 2012, indicating that the device was functioning as intended. No additional, relevant information was received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8444027
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