HIRES¿ ULTRA 3D IMPLANT Adverse Event — Injury (MDR 3006556115-2020-00319)
HIRES¿ ULTRA 3D IMPLANT Adverse Event — Injury (MDR 3006556115-2020-00319) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: HIRES¿ ULTRA 3D IMPLANT; Generic name: COCHLEAR IMPLANT; Manufacturer: ADVANCED BIONICS, LLC.
| Device | HIRES¿ ULTRA 3D IMPLANT |
|---|---|
| Generic name | COCHLEAR IMPLANT |
| Manufacturer | ADVANCED BIONICS, LLC |
| Report number | 3006556115-2020-00319 |
| Event type | Injury |
| Product problem | N |
| Date received | 2020-04-28 |
| Report source | HEALTH PROFESSIONAL |
| Narrative | ADVANCED BIONICS CONSIDERS THE INVESTIGATION INTO THIS REPORTABLE EVENT AS CLOSED. THE RECIPIENT REPORTEDLY RECOVERED. NO FURTHER INFORMATION WILL BE PROVIDED. THE EXTERNAL VISUAL INSPECTION REVEALED SILICONE SLICES ON THE TOP COVER AND THE ELECTRODE WAS SEVERED ALONG THE ELECTRODE AND NEAR THE ARRAY PRIOR TO RECEIPT. THESE ARE BELIEVED TO HAVE OCCURRED DURING REVISION SURGERY. THE DEVICE PASSED T |
| Source | openFDA MAUDE (device adverse events) |
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