HIRES ULTRA 3D IMPLANT Adverse Event — Malfunction (MDR 3006556115-2020-00357)
HIRES ULTRA 3D IMPLANT Adverse Event — Malfunction (MDR 3006556115-2020-00357) 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 | 3006556115-2020-00357 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-27 |
| Report source | HEALTH PROFESSIONAL |
| Narrative | ADVANCED BIONICS CONSIDERS THE INVESTIGATION INTO THIS REPORTABLE EVENT AS CLOSED. THE EXTERNAL VISUAL INSPECTION REVEALED SILICONE DAMAGE ON THE TOP AND BOTTOM COVERS, AND A SLICE ALONG THE ELECTRODE LEAD PRIOR TO RECEIPT. THESE ARE BELIEVED TO HAVE OCCURRED DURING REVISION SURGERY. THE DEVICE PASSED THE PHOTOGRAPHIC IMAGING INSPECTION. SYSTEM LOCK WAS VERIFIED. THE DEVICE PASSED SOME OF THE ELEC |
| Source | openFDA MAUDE (device adverse events) |
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