MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-19 for NUCLEUS HYBRID L24 CI24RE (L24) N/A manufactured by Cochlear Ltd.
[139285368]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[139285369]
Per the clinic, the patient experienced poor performance with device use and a subsequent reduction in clinical benefit, resulting in the decision to explant. The device was explanted on (b)(6) 2019 and the patient was re-implanted with a new device during the same surgery.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6000034-2019-00423 |
| MDR Report Key | 8434856 |
| Date Received | 2019-03-19 |
| Date of Report | 2019-04-30 |
| Date of Event | 2019-02-28 |
| Date Mfgr Received | 2019-04-30 |
| Device Manufacturer Date | 2014-09-05 |
| Date Added to Maude | 2019-03-19 |
| 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 | MS. KRISTEL KOHNE |
| Manufacturer Street | 1 UNIVERSITY AVENUE |
| Manufacturer City | MACQAURIE UNIVERSITY, NSW 2109 |
| Manufacturer Country | AS |
| Manufacturer Postal | 2109 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NUCLEUS HYBRID L24 |
| Generic Name | NUCLEUS HYBRID COCHLEAR IMPLANT SYSTEM |
| Product Code | PGQ |
| Date Received | 2019-03-19 |
| Model Number | CI24RE (L24) |
| Catalog Number | N/A |
| Lot Number | N/A |
| Device Expiration Date | 2016-09-04 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COCHLEAR LTD |
| Manufacturer Address | 1 UNIVERSITY AVENUE MACQUARIE UNIVERSITY, NSW 2109 AS 2109 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-03-19 |