HIRES 90K IMPLANT Adverse Event — Injury (MDR 3006556115-2020-00305)
HIRES 90K IMPLANT Adverse Event — Injury (MDR 3006556115-2020-00305) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: HIRES 90K IMPLANT; Generic name: COCHLEAR IMPLANT; Manufacturer: ADVANCED BIONICS, LLC.
| Device | HIRES 90K IMPLANT |
|---|---|
| Generic name | COCHLEAR IMPLANT |
| Manufacturer | ADVANCED BIONICS, LLC |
| Report number | 3006556115-2020-00305 |
| Event type | Injury |
| Product problem | N |
| Date received | 2020-04-27 |
| Report source | FOREIGN, HEALTH PROFESSIONAL |
| Narrative | ADVANCED BIONICS CONSIDERS THE INVESTIGATION INTO THIS REPORTABLE EVENT AS CLOSED. ADDITIONAL INFORMATION REGARDING TREATMENT DETAILS WERE NOT PROVIDED. THE EXTERNAL VISUAL INSPECTION REVEALED THAT THE SILICONE WAS CUT ON THE TOP COVER AND THE ELECTRODE WAS SEVERED PRIOR TO RECEIPT. THIS IS BELIEVED TO HAVE OCCURRED DURING REVISION SURGERY. THE DEVICE PASSED THE PHOTOGRAPHIC IMAGING INSPECTION. SY |
| Source | openFDA MAUDE (device adverse events) |
🔍 Search all device adverse events →
$1999/mo
Try DeviceEvents →