It was reported that a vns device was replaced due to battery depletion and was received by the manufacturer.Analysis was completed for the returned generator.The end-of-service condition was not confirmed.There was no indication from the device that an end of service condition existed.The device performed as expected according to functional specifications.Analysis concluded that no abnormal performance or any other type of adverse condition was found.Follow-up from the provider verified that the replacement was prophylactic, and the device was not at end-of-service.The patient was reported to have had an increase in seizures.It was unknown if the increase in seizures was due to vns therapy.Additional relevant information has not been received to-date.
|