MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2020-03-26 for HIRES 90K? IMPLANT CI-1400-01 NA manufactured by Advanced Bionics, Llc.
[186706984]
The recipient reportedly experienced skin flap breakdown at the implant site, which led to device extrusion. The recipient's device was explanted. The recipient was reimplanted with another advanced bionics cochlear device on the contralateral side. The recipient did not receive medical intervention prior to explantation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006556115-2020-00161 |
| MDR Report Key | 9885528 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2020-03-26 |
| Date of Report | 2020-03-05 |
| Date of Event | 2020-03-12 |
| Device Manufacturer Date | 2007-11-30 |
| Date Added to Maude | 2020-03-26 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | BROOKE LOPEZ |
| Manufacturer Street | 28515 WESTINGHOUSE PLACE |
| Manufacturer City | VALENCIA CA 91355 |
| Manufacturer Country | US |
| Manufacturer Postal | 91355 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HIRES 90K? IMPLANT |
| Generic Name | COCHLEAR IMPLANT |
| Product Code | MCM |
| Date Received | 2020-03-26 |
| Model Number | CI-1400-01 |
| Catalog Number | NA |
| Lot Number | NA |
| Device Expiration Date | 2009-10-01 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ADVANCED BIONICS, LLC |
| Manufacturer Address | 28515 WESTINGHOUSE PLACE VALENCIA CA 91355 US 91355 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-26 |