It was reported that the patient had vns generator and lead explant surgery due to infection shortly after the patient had generator replacement surgery.The patient then required another surgery several months later due to an extruding tie-down.The surgeon removed the extruding tie-down, a tie-down that was covered in fibrous tissue, and sutures from the lead area.The surgeon reportedly did not know the cause of the tie-down extrusion or infection.The device history records of the generator and lead were reviewed, and both devices were sterilized according to procedure prior to release.No further relevant information has been received to date.
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