MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2007-05-18 for NUCLEUS 24 AUDITROY BRAINSTEM IMPLANT SYSTEM ABI24M NA manufactured by Cochlear Ltd..
[17887647]
Per the audiologist's report, the patient developed an infection "immediately" after implant surgery. The patient was treated with antibiotics. Reportedly, the infection returned whenever the patient stopped taking antibiotics. The device was explanted in 2007. Reportedly, a culture showed mrsa. It was reported twelve days later, that the patient had recovered and had been discharged from the hospital.
Patient Sequence No: 1, Text Type: D, B5
[17964744]
.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 6000034-2007-00211 |
| MDR Report Key | 851585 |
| Report Source | 05 |
| Date Received | 2007-05-18 |
| Date of Report | 2007-05-17 |
| Date of Event | 2007-01-29 |
| Date Mfgr Received | 2007-04-26 |
| Date Added to Maude | 2007-05-21 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | RONALD CHAPMAN |
| Manufacturer Street | 400 INVERNESS PARKWAY SUITE 400 |
| Manufacturer City | ENGLEWOOD CO 80112 |
| Manufacturer Country | US |
| Manufacturer Postal | 80112 |
| Manufacturer Phone | 7207909010 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NUCLEUS 24 AUDITROY BRAINSTEM IMPLANT SYSTEM |
| Generic Name | AUDITORY BRAINSTEM IMPLANT |
| Product Code | MHE |
| Date Received | 2007-05-18 |
| Returned To Mfg | 2007-05-11 |
| Model Number | ABI24M |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Device Sequence No | 1 |
| Device Event Key | 838648 |
| Manufacturer | COCHLEAR LTD. |
| Manufacturer Address | 14 MARS ROAD LANE COVE, NSW AS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2007-05-18 |