MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2015-09-10 for NUCLEUS 24 AUDITORY BRAINSTEM IMPLANT SYSTEM ABI541 manufactured by Cochlear Ltd..
[25498669]
Implanted device remains.
Patient Sequence No: 1, Text Type: N, H10
[25498670]
Per the clinic, the patient experienced intermittencies and subsequent loss of connection to the internal device, however, the issue could not be resolved. The implanted device remains. It is unknown if there are plans to explant the device and reimplant the patient with a new device as of the date of this report.
Patient Sequence No: 1, Text Type: D, B5
[42794514]
Per the clinic, the device was explanted on (b)(6) 2016, and the patient was reimplanted with a new device on the contralateral side during the same surgery. Device not returned to manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[47795192]
Correction: the device was not explanted as previously reported. The device remains insitu. This report is filed june 21, 2016. Implanted device remains.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 6000034-2015-01898 |
| MDR Report Key | 5069689 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2015-09-10 |
| Date of Report | 2016-06-03 |
| Date of Event | 2015-08-25 |
| Date Mfgr Received | 2016-06-03 |
| Date Added to Maude | 2015-09-10 |
| 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 |
| Reporter Occupation | AUDIOLOGIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. BIANCA HANLON |
| Manufacturer Street | 1 UNIVERSITY AVENUE |
| Manufacturer City | MACQUARIE UNIVERSITY, NSW 2109 |
| Manufacturer Country | AS |
| Manufacturer Postal | 2109 |
| Manufacturer Phone | 2 9428 655 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NUCLEUS 24 AUDITORY BRAINSTEM IMPLANT SYSTEM |
| Generic Name | MHE |
| Product Code | MHE |
| Date Received | 2015-09-10 |
| Model Number | ABI541 |
| 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 PO BOX 629 MACQAURIE UNIVERSITY, NSW 2109 AS 2109 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-09-10 |