MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-03 for NUCLEUS? HYBRID S12 CI24RE (S12) NA manufactured by Cochlear Ltd.
[173448841]
This report is submitted on january 3, 2020.
Patient Sequence No: 1, Text Type: N, H10
[173448842]
Per the clinic, the patient experienced poor performance with the device. Reprogramming attempts were made; however, the issue could not be resolved. The device was explanted (b)(6) 2019 and the patient was reimplanted with a new device during the same surgery.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6000034-2020-00051 |
| MDR Report Key | 9542240 |
| Date Received | 2020-01-03 |
| Date of Report | 2019-12-12 |
| Date of Event | 2019-11-21 |
| Report Date | 2020-01-03 |
| Date Reported to FDA | 2020-01-03 |
| Date Reported to Mfgr | 2019-12-12 |
| Date Added to Maude | 2020-01-03 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NUCLEUS? HYBRID S12 |
| Generic Name | NUCLEUS 24 COCHLEAR IMPLANT SYSTEM |
| Product Code | PGQ |
| Date Received | 2020-01-03 |
| Model Number | CI24RE (S12) |
| Catalog Number | NA |
| Lot Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COCHLEAR LTD |
| Manufacturer Address | 1 UNIVERSITY AVENUE MACQUARIE UNIVERSITY, 2109 AS 2109 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-01-03 |