MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2016-10-11 for NUCLEUS 24 AUDITORY BRAINSTEM IMPLANT SYSTEM ABI541 manufactured by Cochlear Ltd..
[57040394]
Patient and initial implantation details unavailable at the time of this report. Device not returned to manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[57040395]
Per the clinic, the patient experienced migration of the electrode array; subsequently the device was explanted (date not reported) during a procedure to reposition the electrode array. The patient was re-implanted with a new device during the same surgery.
Patient Sequence No: 1, Text Type: D, B5
[59924804]
This mdr was a duplicate. Any further information will be provided with report number 6000034-2016-01974. This report is filed on (b)(6) 2016.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 6000034-2016-02013 |
| MDR Report Key | 6019489 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2016-10-11 |
| Date of Report | 2016-11-10 |
| Date Mfgr Received | 2016-11-10 |
| Device Manufacturer Date | 2015-08-04 |
| Date Added to Maude | 2016-10-11 |
| 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 | MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE |
| 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 | 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 | 2016-10-11 |
| Model Number | ABI541 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COCHLEAR LTD. |
| Manufacturer Address | 1 UNIVERSITY AVENUE MACQAURIE UNIVERSITY, NSW 2109 AS 2109 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-10-11 |