FDA Adverse Event
Other
Summary report: N
CLARION
MDR report key: 283363
·
Received June 21, 2000
Report
- Report Number
- 2029203-2000-00014
- Event Type
- Other
- Date Received
- June 21, 2000
- Date of Event
- May 16, 2000
- Report Date
- June 15, 2000
- Manufacturer
- ADVANCED BIONICS CORPORATION
- Product Code
- MCM
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- SERVICE PERSONNEL
Narratives
Description of Event or Problem · 1
THE PT WAS SEEN AT THE IMPLANT CTR FOR DEVICE EVAL IN 2000. TESTING AT THE CENTER CONFIRMED THAT PT'S DEVICE WAS NO LONGER FUNCTIONING. REVISION SURGERY TOOK PLACE IN 2000 AND THE PT WAS REIMPLANTED WITH ANOTHER CLARION DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CLARION | COCHLEAR IMPLANT | MCM | ADVANCED BIONICS CORPORATION | AB-5100R | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 6 YR |