FDA Adverse Event
Malfunction
Summary report: N
CLARION
MDR report key: 2231631
·
Received August 22, 2011
Report
- Report Number
- 3006556115-2011-00402
- Event Type
- Malfunction
- Date Received
- August 22, 2011
- Date of Event
- July 21, 2011
- Report Date
- August 1, 2011
- Manufacturer
- ADVANCED BIONICS, LLC
- Product Code
- MCM
- PMA / PMN Number
- P960058
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THE COMPANY WAS MADE AWARE THAT THE PATIENT'S DEVICE WAS EXPLANTED DUE TO INTERMITTENCIES. THE PATIENT WAS REIMPLANTED WITH ANOTHER COCHLEAR IMPLANT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CLARION | COCHLEAR IMPLANT | MCM | ADVANCED BIONICS, LLC | AB-5100H-01A | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 12 YR |