It was reported that a vns patient underwent full revision surgery on (b)(6) 2016.The generator was replaced due to battery depletion and the lead was replaced due to "insulation/ isolation failure".No patient adverse events were reported.Review of manufacturing records confirmed all tests passed for the lead prior to distribution.It was reported that the explanted devices will not be returned to the manufacturer, as they were discarded; therefore no analysis results could be provided.No additional information was provided to date.
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