Report received that a patient's generator and lead were explanted due to an infection.This occurred about 14 months after the initial implant.Further information was provided from the explanting surgeon that, at the time of the explant, the patient presented with wound dehiscence and an open pocket.The generator was reportedly seen coming out of this open wound with pus.There was reportedly no note of the patient picking at the generator.A review of the generator's device history record indicated it had been properly sterilized prior to release for distribution.No further relevant information has been received to date.
|