MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2017-11-12 for NUCLEUS ABI541 AUDITORY BRAINSTEM IMPLANT N/A manufactured by Cochlear Ltd.
[91875793]
This report is submitted on november 13, 2017, by cochlear limited on behalf of cochlear americas. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[91875794]
Per the clinic, the patient experienced no auditory response with the device. Subsequently, a ct scan performed on (b)(6) 2017, revealed that the implant had migrated out of the cochlea. Revision surgery to reposition the device is planned; however, yet to occur as of the date of this report november 13, 2017.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6000034-2017-02060 |
| MDR Report Key | 7023816 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2017-11-12 |
| Date of Report | 2017-11-01 |
| Date Mfgr Received | 2017-11-01 |
| Device Manufacturer Date | 2016-01-29 |
| Date Added to Maude | 2017-11-12 |
| 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. SUJEEWA WIJESINGHE |
| Manufacturer Street | 1 UNIVERSITY AVENUE |
| Manufacturer City | MACQUARIE 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 ABI541 AUDITORY BRAINSTEM IMPLANT |
| Generic Name | NUCLEUS AUDITORY BRAINSTEM IMPLANT SYSTEM |
| Product Code | MHE |
| Date Received | 2017-11-12 |
| Model Number | ABI541 |
| Catalog Number | N/A |
| Lot Number | N/A |
| Device Expiration Date | 2018-01-28 |
| Operator | LAY USER/PATIENT |
| Device Availability | * |
| Device Eval'ed by Mfgr | N |
| 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 | 2017-11-12 |