FDA Adverse Event
Other
Summary report: N
CLARION
MDR report key: 211193
·
Received February 19, 1999
Report
- Report Number
- 2029203-1999-00003
- Event Type
- Other
- Date Received
- February 19, 1999
- Date of Event
- January 20, 1999
- Report Date
- January 21, 1999
- Manufacturer
- ADVANCED BIONICS CORPORATION
- Product Code
- MCM
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
A 39 YEAR-OLD MALE, WAS ORIGINALLY IMPLANTED ON 2/8/1994. HIS SYSTEM FUNCTIONED NORMALLY AND THERE WERE NO REPORTS OF ANY PROBLEMS OVER THE NEXT FIVE YEARS. ACCORDING TO INFO RECEIVED FROM THE IMPLANT CENTER, THE PT HAD BEEN DRINKING WHEN HE FELL DOWN AND STRUCK HIS HEAD ON A CAR DOOR. THERE WAS AN IMMEDIATE CESSATION OF DEVICE FUNCTIONALITY. TESTING CONDUCTED AT THE CENTER ON 1/21/1999, CONFIRMED THAT DEVICE WAS NO LONGER FUNCTIONING. EXPLANTATION/REIMPLANTATION TOOK PLACE ON 1/25/1999. PT WAS REIMPLANTED WITH ANOTHER CLARION DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CLARION Implant | COCHLEAR IMPLANT | MCM | ADVANCED BIONICS CORPORATION | MMT-5100L | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 39 YR |