(b)(4).The recipient reportedly sustained an injury to the implant site which resulted in inflammation and worsened over time.The recipient was recommended zithromycin on (b)(6) 2015 for three months.The recipient underwent irrigation and device explant on (b)(6) 2016.Inflammation and infection resolved after device explant.The external visual inspection revealed that the electrode was severed prior to receipt.This is believed to have occurred during revision surgery.The device passed the photographic imaging inspection.System lock was verified.The electrode condition prevented one of the electrical tests from being performed.The device passed the electrical and mechanical tests performed.This device was explanted for medical reasons.The device passed the tests performed.This is the final report.
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