It was reported that the vns patient underwent surgery on (b)(6) 2014 to explant his generator and lead due to infection and subcutaneous abscess formation which resulted from patient manipulation of the device.The explanted generator and lead were returned to the manufacturer for analysis.There were no performance or any other type of adverse conditions found with the pulse generator.Other than typical wear and explant related observations, no anomalies were identified in the returned lead.A review of device history records showed that both the lead and generator were sterilized prior to distribution.The patient has not been re-implanted to date.
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