MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2017-01-22 for NUCLEUS 24 ABI ABI24M N/A manufactured by Cochlear Ltd.
[65453057]
This report is submitted on january 23, 2017.
Patient Sequence No: 1, Text Type: N, H10
[65453058]
Per the clinic, the patient experienced a dislodged internal magnet during an mri (tesla 1. 5). It was reported that the patient's head was not wrapped per the manufacturers specifications for use with mri. Revision surgery is planned; however, yet to occur as of the date of this report.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6000034-2017-00147 |
| MDR Report Key | 6269192 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2017-01-22 |
| Date of Report | 2017-01-09 |
| Date Mfgr Received | 2017-01-09 |
| Date Added to Maude | 2017-01-22 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| 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 | 94286555 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NUCLEUS 24 ABI |
| Generic Name | NUCLEUS AUDITORY BRAINSTEM IMPLANT SYSTEM |
| Product Code | MHE |
| Date Received | 2017-01-22 |
| Model Number | ABI24M |
| Catalog Number | N/A |
| Lot Number | N/A |
| Operator | LAY USER/PATIENT |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| 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 | 2017-01-22 |