Device 2 of 2.Reference mfr.Report# 1627487-2017-04249.It was reported the patient ((b)(6)) experienced discomfort, swelling and redness with stimulation around the facial lead.System diagnostics determined normal impedances.The patient was prescribed antibiotics for a time being.Subsequently, the patient underwent surgical intervention on (b)(6) 2017 wherein the alleged lead was explanted which resolved the issue.It is unknown which lead is related to the issue.Therefore, all the suspected devices are being reported as explanted.
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