FDA Adverse Event
Injury
Summary report: N
CLARION
MDR report key: 378539
·
Received February 19, 2002
Report
- Report Number
- 2029203-2002-00045
- Event Type
- Injury
- Date Received
- February 19, 2002
- Date of Event
- January 11, 2001
- Report Date
- February 19, 2002
- Manufacturer
- ADVANCED BIONICS CORPORATION
- Product Code
- MCM
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OK, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
THE DEVICE REPORTEDLY EXTRUDED IN SEPTEMBER 2000. REVISION SURGERY WAS PERFORMED AND THE DEVICE WAS REPOSITIONED SUCCESSFULLY IN OCTOBER 2000. ACCORDING TO THE INFORMATION RECEIVED FROM THE CENTER, THERE WERE CONTINUING PROBLEMS WITH FLAP BREAKDOWN AND THE SURGEON DECIDED TO REMOVE THE DEVICE IN 2001. THE PATIENT WAS REIMPLANTED WITH ANOTHER CLARION DEVICE 6 MONTHS LATER.
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 | 68 YR | Required Intervention |