MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2006-03-03 for NUCLEUS 24 AUDITORY BRAINSTEM IMPLANT SYSTEM ABI 24M NA manufactured by Cochlear Ltd..
[402846]
This pt has an auditory brainstem implant that is not in use and only serves as a sleeper for the time being. The implant is just below the skin and does not have a magnet. The audiologist recently could not get telemetry or stimulate the device (4 years post-implantation). Integrity testing performed in 02/2006 confirmed failure of the implant. The surgeon will inform cochlear of his/her decision to either replace this device (should he/she remove it) or implant a new device on the contralateral side. A surgery has not been scheduled at this time.
Patient Sequence No: 1, Text Type: D, B5
[438498]
This pt has an auditory brainstem implant that is not in use and only serves as a sleeper for the time being. The implant is just below the skin and does not have a magnet. The audiologist recently could not get telemetry or stimulate the device (4 years post-implantation). Integrity testing performed in (b)(6) 2006 confirmed failure of the implant. The surgeon will inform cochlear of his/her decision to either replace this device (should he/she remove it) or implant a new device on the contralateral side. A surgery has not been scheduled at this time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6000034-2006-00082 |
| MDR Report Key | 682370 |
| Report Source | 07 |
| Date Received | 2006-03-03 |
| Date of Report | 2006-03-03 |
| Date of Event | 2005-12-12 |
| Date Mfgr Received | 2006-02-06 |
| Date Added to Maude | 2006-03-09 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | BRANDY FONTENOT |
| Manufacturer Street | 400 INVERNESS PKWY STE 400 |
| Manufacturer City | EAGLEWOOD CO 80112 |
| Manufacturer Country | US |
| Manufacturer Postal | 80112 |
| Manufacturer Phone | 7207909010 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NUCLEUS 24 AUDITORY BRAINSTEM IMPLANT SYSTEM |
| Generic Name | AUDITORY BRAINSTEM IMPLANT |
| Product Code | MHE |
| Date Received | 2006-03-03 |
| Model Number | ABI 24M |
| Catalog Number | NA |
| Lot Number | * |
| ID Number | * |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | Y |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 671638 |
| Manufacturer | COCHLEAR LTD. |
| Manufacturer Address | 14 MARS ROAD LANE COVE, NSW AS |
| Baseline Brand Name | NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM |
| Baseline Generic Name | COCHLEAR IMPLANT |
| Baseline Model No | ABI 24M |
| Baseline Catalog No | NA |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2006-03-03 |