MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-02-19 for NUCLEUS 24 AUDITORY BRAINSTEM IMPLANT SYSTEM ABI541 manufactured by Cochlear Ltd ..
[39020683]
This report is filed february 18, 2016. The implanted device remains.
Patient Sequence No: 1, Text Type: N, H10
[39020684]
Per the clinic, the internal magnet became dislodged for unknown reasons. The implanted device remains.
Patient Sequence No: 1, Text Type: D, B5
[49135146]
Per the clinic, the patient underwent revision surgery on (b)(6) 2016 to reposition the internal magnet. The implanted device remains. This report is filed july 8, 2016.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 6000034-2016-00326 |
| MDR Report Key | 5448654 |
| Date Received | 2016-02-19 |
| Date of Report | 2016-02-23 |
| Date Mfgr Received | 2016-01-27 |
| Date Added to Maude | 2016-02-19 |
| 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. ANGEL WRIGHT |
| Manufacturer Street | 13059 EAST PEAKVIEW AVENUE |
| Manufacturer City | CENTENNIAL CO 80111 |
| Manufacturer Country | US |
| Manufacturer Postal | 80111 |
| Manufacturer Phone | 3037909010 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NUCLEUS 24 AUDITORY BRAINSTEM IMPLANT SYSTEM |
| Generic Name | MCM |
| Product Code | MHE |
| Date Received | 2016-02-19 |
| 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 | 14 MARS RD LANE COVE, NSW 2066 AS 2066 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-02-19 |