A patient underwent full vns revision surgery due to end-of service of the device.The explanted lead and generator were received by the manufacturer.Analysis was completed for the returned lead.The outer tubing was abraded open.The positive coil has pitting at the coil end located at the end of the cut, first portion of the returned lead.The electrode array portion was not returned for analysis and evaluation and could not be made on that portion of the lead.Other than the above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead portions.Analysis was performed on the returned generator which confirmed the end-of-service condition.Review of the downloaded data showed the last >25% change in impedance indicates high impedance during device implant occurring (b)(6) 2017.With the generator case removed and the battery still attached, the battery measured 1.988 volts, confirming an end-of-service condition.(b)(4) of the battery had been consumed.The electrical test results show that the printed circuit board assembly performs according to functional specifications.The electrical performance of the generator was used to conclude that no anomalies exist and the end-of-service condition is an expected event.There were no additional performance or any other type of adverse conditions found with the pulse generator.
|