It was initially reported by the patient's mother that she was concerned about the patient's surgical site.The site was determined to be swollen by the surgeon, and she was reportedly asked by the surgeon to follow up if the patient's swelling persists.In the investigation of this issue, follow-up communication with the surgeon's office on (b)(6) 2015 indicated that the surgeon suspected a post-surgical superficial infection with antibiotics prescribed as treatment.Review of device manufacturing record confirmed sterilization for the generator prior to distribution.In addition to the infection, the surgeon also believed that the patient's tendency to hit himself may have contributed to the swelling experienced.No additional pertinent information has been received to date.
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