Reporter indicated a patient was having increased seizures that were felt to be due to a depleting vns generator, even though the generator was not at end of service.
The generator was replaced prophylactically due to anticipation of a near end of service condition.
The patient later had generator replacement surgery performed.
The explanted generator has been returned and is pending analysis.
Attempts for further information are in progress.
Event Description
Product analysis of the vns generator was completed.
Electrical test results showed that the pulse generator performed according to functional specifications.
There were no adverse functional, mechanical, or visual issues identified with the returned generator.
All attempts to the reporter for further information have been unsuccessful to date.