HIRES¿ ULTRA IMPLANT Adverse Event — Malfunction (MDR 3006556115-2019-00837)
HIRES¿ ULTRA IMPLANT Adverse Event — Malfunction (MDR 3006556115-2019-00837) 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.
| Device | HIRES¿ ULTRA IMPLANT |
|---|---|
| Generic name | COCHLEAR IMPLANT |
| Manufacturer | ADVANCED BIONICS, LLC |
| Report number | 3006556115-2019-00837 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-28 |
| Report source | Health Professional |
| Narrative | ADVANCED BIONICS CONSIDERS THE INVESTIGATION INTO THIS REPORTABLE EVENT AS CLOSED. THE DEVICE PASSED THE EXTERNAL VISUAL AND PHOTOGRAPHIC IMAGING INSPECTIONS. SYSTEM LOCK WAS VERIFIED. THE DEVICE PASSED THE ELECTRICAL TESTS PERFORMED. ADVANCED ELECTRICAL TESTING PERFORMED ON THE DEVICE SHOWED LOWER THAN TYPICAL RANGE ON SOME OF THE ELECTRODES. IT IS THE OPINION OF ADVANCED BIONICS EXPLANT REVIEW B |
| Source | openFDA MAUDE (device adverse events) |
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