It was reported that a patient's wound did not properly heal after her generator replacement surgery on (b)(6) 2016.The patient had two visits to the emergency room and underwent antibiotic treatment, but the wound opened and the generator was visible.The patient's device was then explanted.The device history records of both the generator and lead were reviewed, and the devices were sterilized according to procedure prior to release.The operative report was received from the explanting facility.The patient's wound swelled over the course of a few days and dehisced.The patient was admitted to the intensive care unit and had the generator and most of the lead explanted on (b)(6) 2016 so antibiotics could treat the infection.A suture granuloma was removed from where the generator was placed, and there was an area above the incision of necrotic tissue that was removed as well.No further relevant information has been received to date.
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It was reported that the patient started having redness and swelling at the left neck.The physician performed an ultrasound, which identified a cyst surrounding the remaining portion of the lead.The physician aspirated fluid from the cyst, which was dirty; and looked infected.The patient then had the remainder of the lead explanted.No further relevant information has been received to date.
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