MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2003-09-30 for NUCLEUS 24 AUDITORY BRAINSTEM IMPLANT SYSTEM ABI24M NA manufactured by Cochlear Ltd..
[303176]
The patient succumbed to complications following surgery of a very large acoustic neuroma. The tumor caused significant brainstem compression and the patient died of respiratory complications.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6000034-2003-00216 |
| MDR Report Key | 486118 |
| Report Source | 05 |
| Date Received | 2003-09-30 |
| Date of Report | 2003-09-30 |
| Date of Event | 2003-04-11 |
| Date Mfgr Received | 2003-08-04 |
| Date Added to Maude | 2003-10-02 |
| 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 DRIVE 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 | 24 CHANNEL COCHLEAR IMPLANT |
| Product Code | MHE |
| Date Received | 2003-09-30 |
| Model Number | ABI24M |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | Y |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 475003 |
| 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 | 1. Death | 2003-09-30 |