It was reported that the patient underwent vns generator replacement due to battery depletion and the desire for a new vns generator model.The explanted product was received by the manufacturer.Generator product analysis was completed.The generator diagnostics were as expected for the programmed parameters.The battery measured 2.916 v at the completion of the fet.The generator performed according to functional specifications with the exception of the output pulse risetime test, which failed multiple times.The generator case was removed and cracks and discoloration were observed on the feed-thru capacitor, as well as separation of the silver polymide on the feed-thru capacitor wires.Testing with a known good printed circuit board assembly attached to the case with the suspected feed-thru capacitor confirmed that the capacitor was the source of the output pulse risetime failure.Other than the noted event, there were no additional performance or other adverse conditions found with the generator.A review of device history records revealed that the generator was sterilized and passed quality control inspection prior to distribution.No additional relevant information has been received to date.
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