Report received that a patient's generator was exposed in the left chest.The patient was reportedly admitted to the hospital and put on antibiotics before the generator was to be explanted.Further information was received that the patient's neurologist believed an infection caused the generator to extrude from the skin, but the origin of the infection was reportedly unknown.Further information was received from operative notes that about a month prior to the extrusion, the patient presented with multiple erythematous areas over her neck and chest.It was noted that the patient's neurologist evaluated these bumps and determined they were related to insect bites.However, it appeared the patient did not recover with antibiotics and the generator began to extrude from the wound.It was not stated whether these insect bites led to the infection.The patient's mother reported that the site opened up and a gush of red tinged drainage was seen.The op-notes stated that during the explant, the generator was removed and the wound was cleaned.They also indicated that the surgeon removed some scar tissue in the generator area while performing the surgery.A review of the device history record indicated the generator had been properly sterilized to specifications prior to release for distribution.No further relevant information has been received to date.
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