MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2005-08-10 for NUCLEUS 24 AUDITORY BRAINSTEM IMPLANT SYSTEM ABI 24M NA manufactured by Cochlear Ltd..
[20526516]
This pt developed meningitis four days after surgery to remove a large acoustic neuroma and implant a nucleus auditory brainstem implant, and after three days of intubation with a lumbar catheter. Antibiotic treatment was administered immediately upon the presentation of symptoms and lasted 14 days. The treatment was then extended for four more weeks, as symptoms of meningitis reappeared. The hosp suspects that the catheter may have introduced the pathogen and has initiated an investigation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6000034-2005-00224 |
| MDR Report Key | 625259 |
| Report Source | 05 |
| Date Received | 2005-08-10 |
| Date of Report | 2005-08-10 |
| Date of Event | 2005-07-11 |
| Date Mfgr Received | 2005-08-09 |
| Date Added to Maude | 2005-08-11 |
| 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 DRIVE 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 | 2005-08-10 |
| 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 | 614887 |
| 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 | 2005-08-10 |