MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-02-17 for NUCLEUS ABI541 AUDITORY BRAINSTEM IMPLANT NA manufactured by Cochlear Ltd.
[136460211]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[136460212]
Per the surgeon, the patient experienced poor performance and subsequently the device was explanted on (b)(6) 2018. The patient was reimplanted with a new device during the same surgery.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6000034-2018-02507 |
| MDR Report Key | 8346564 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-02-17 |
| Date of Report | 2019-09-18 |
| Date Mfgr Received | 2019-09-18 |
| Device Manufacturer Date | 2018-03-01 |
| Date Added to Maude | 2019-02-17 |
| 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 |
| Manufacturer G1 | COCHLEAR BONE ANCHORED SOLUTIONS AB |
| Manufacturer Street | KONSTRUKTIONSV PO BOX 82 |
| Manufacturer City | M 43533 |
| Manufacturer Country | SW |
| Manufacturer Postal Code | 43533 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NUCLEUS ABI541 AUDITORY BRAINSTEM IMPLANT |
| Generic Name | NUCLEUS AUDITORY BRAINSTEM IMPLANT SYSTEM |
| Product Code | MHE |
| Date Received | 2019-02-17 |
| Model Number | ABI541 |
| Catalog Number | NA |
| Lot Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| 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 | 2019-02-17 |