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[dennis100]

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 07/01/2018
Event Type  Injury   
Event Description
It was reported that the patient had been referred for vns replacement surgery, and follow up with the patient's neurologist determined that this was due to an increase in seizures. The neurologist suspected this was due to a depleted battery; however, no confirmation of an end-of-service battery status has been received and a battery life estimation performed with the available programming data did not support an end-of-service status. It was reported that the device was checked in july and was noted to be stable. 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=8250731

[dennis100]

Model Number 1000
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 10/18/2018
Event Type  Death   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported by the physician that the patient had passed away due to sudden unexpected death in epilepsy (sudep). The patient's mother indicated that the vns contributed to the patient's passing; however, the physician reported that was not the case. The physician indicated that the patient's death was not attributed to vns. The last system diagnostics known for the patient were within normal limits. The mother reported that on the day of the patient's death he had a slight seizure around 8 am and his heart stopped. The emt worked on him for several hours but he was eventually pronounced dead at 11 am. The patient's mother additionally reported that the patient's vns had been turned off for an mri a few weeks before the patient's passing and was turned on by a different neurologist. The mother reported that the son thought the neurologist had turned on the stimulation too high and wanted the generator explanted. She reported that the patient's generator would constantly turn on and off, and that it affected the patient's vocal cords. She reported that the patient's device was not helping him and that there was an increase in seizure frequency. She also reported that the patient had horrible heartburn and was agitated the day before he passed away. The patient's autopsy came back negative for any abnormal tests. The suspect product has not been received to date. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8242124

[dennis100]

Model Number 103
Event Date 01/01/2014
Event Type  Injury   
Event Description
Additional information with device settings were received. The vns duty cycle was adjusted on (b)(6) 2014.
 
Manufacturer Narrative
Adverse event, corrected data: additional information was received that intervention was taken for the increase in seizures; therefore, this field is being corrected to adverse event. Outcomes attributed to adverse event, corrected data: additional information was received that intervention was taken for the increase in seizures; therefore, this field is being updated to show that intervention was taken. Type of reportable event, corrected data: additional information was received that intervention was taken for the increase in seizures; therefore, this field is being corrected to adverse event.
 
Manufacturer Narrative

Event Description
It was reported that the patient has been experiencing an increase in seizures. It is unknown if the seizures are above the patient's pre-vns baseline frequency. Attempts to obtain additional information will be made, but no additional information has been received to date.
 
Event Description
Attempts for additional information were unsuccessful.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3657689

[dennis100]

Model Number 102
Event Date 04/01/2009
Event Type  Malfunction   
Event Description
A vns pt's wife called and reported that her husband is implanted with the vns for depression. She called mfr for mri precautions. She reported that her husband had a seizure in (b)(6) of this year. He also lost (b)(6) pounds in the last 8 months and recently has had more seizures. Additionally reported that he is also experiencing left foot drop and left leg paralysis and that is why they need to do an mri. Good faith attempts are being made to determine if the reported events are related to their vns.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1577003

[dennis100]

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/01/2018
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported via clinic notes received by the manufacturer that the patient was experiencing an increase in seizures, approximately 2-3 a week, and migration of the vns generator. The patient underwent prophylactic vns generator replacement surgery. The explanted generator has not been received by the manufacturer to date. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8210610

[dennis100]

Model Number 103
Event Date 02/23/2015
Event Type  Malfunction   
Event Description
It was reported that the vns patient¿s device showed an ifi condition after being implanted for approximately two years and the patient was experiencing an increase in seizures. The ifi condition is believed to be premature battery depletion. A battery life calculation using the available programming history showed approximately 1. 3 years remaining. Attempts for additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4638131

[dennis100]

Model Number 104
Event Date 01/01/2015
Event Type  Malfunction   
Event Description
It was reported that the patient's seizures are worse at times, but it is unknown whether or not the increase is above the patient's pre-vns baseline frequency. The patient believes that the generator battery is low. The patient reported that she still feels device stimulation, but that the seizures are changing and are more frequent at night. The patient reported that she has not been seen by the physician for a year and needs to find a new physician to have the device checked. Attempts to obtain additional relevant information have been unsuccessful to date.
 
Event Description
Additional information was received stating that the vns patient had scheduled an appointment with a new physician to check the device but then cancelled the appointment. The patient has not been seen by a physician to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4627745