MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2002-09-11 for NUCLEUS 24 AUDITORY BRAINSTEM IMPLANT SYSTEM ABI24M NA manufactured by Cochlear Ltd..
[259943]
During surgery to reposition the electrode array of the abi, the device intermittently then completely failed to generate any pulses. Using the appropriate diagnostic equipment, it was determined that the device is not functioning according to manufacturer's specifications. Explantation/reimplantation surgery was performed on 2002. The healthcare professional has been informed that the explanted device should be returned to cochlear ltd.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6000034-2002-00060 |
| MDR Report Key | 416190 |
| Report Source | 05 |
| Date Received | 2002-09-11 |
| Date of Report | 2002-09-10 |
| Date of Event | 2002-02-26 |
| Date Mfgr Received | 2002-04-04 |
| Date Added to Maude | 2002-09-16 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | MARILYN NELSON, R.N. |
| Manufacturer Street | 400 INVERNESS DR SOUTH SUITE 400 |
| Manufacturer City | ENGLEWOOD CO 80112 |
| Manufacturer Country | US |
| Manufacturer Postal | 80112 |
| Manufacturer Phone | 3037909010 |
| 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 | 2002-09-11 |
| Returned To Mfg | 2002-04-18 |
| Model Number | ABI24M |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Age | NA |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 405221 |
| Manufacturer | COCHLEAR LTD. |
| Manufacturer Address | 14 MARS ROAD LANE COVE, NSW AS 2066 |
| Baseline Brand Name | NUCLEUS 24 AUDITORY BRAINSTEM IMPLANT SYSTEM |
| Baseline Generic Name | ABI |
| Baseline Model No | ABI24M |
| Baseline Catalog No | Z43004 |
| Baseline ID | NA |
| Baseline Device Family | AUDITORY BRAINSTEM IMPLANT |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 24 |
| Baseline PMA Flag | Y |
| Premarket Approval | P0000 |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2002-09-11 |