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HIRES ULTRA IMPLANT Adverse Event — Injury (MDR 3006556115-2020-00360)

HIRES ULTRA IMPLANT Adverse Event — Injury (MDR 3006556115-2020-00360) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: HIRES ULTRA IMPLANT; Generic name: COCHLEAR IMPLANT; Manufacturer: ADVANCED BIONICS, LLC.

DeviceHIRES ULTRA IMPLANT
Generic nameCOCHLEAR IMPLANT
ManufacturerADVANCED BIONICS, LLC
Report number3006556115-2020-00360
Event typeInjury
Product problemN
Date received2020-04-27
Report sourceOTHER
NarrativeTHE RECIPIENT IS ELECTING REVISION SURGERY, DESPITE DEVICE TESTING BEING WITHIN NORMAL LIMITS. REVISION SURGERY WILL BE SCHEDULED.
SourceopenFDA MAUDE (device adverse events)

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