Per the clinic, the patient developed a seroma at the implant incision site and subsequently was treated with antibiotics (specific type, date and duration not reported).A section of the incision site was opened (specific date not reported) to allow drainage of the seroma.Additional information has been requested but has not been made available as of the date of this report.
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It was also reported that the patient was placed under general anesthesia (specific date not reported).Subsequently, the device was explanted on (b)(6) 2023.There are plans to explant the device and to reimplant the patient with a new device; however, this has not occurred as of the date of this report.This report is submitted on january 24, 2024.
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