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