FDA Adverse Event
Malfunction
Summary report: N
CLARION
MDR report key: 1083062
·
Received March 5, 2008
Report
- Report Number
- 3006556115-2008-00120
- Event Type
- Malfunction
- Date Received
- March 5, 2008
- Date of Event
- February 20, 2008
- Report Date
- February 20, 2008
- Manufacturer
- ADVANCED BIONICS, LLC
- Product Code
- MCM
- PMA / PMN Number
- P960058
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- AUDIOLOGIST
Narratives
Description of Event or Problem · 1
THE PATIENT IS REPORTEDLY EXPERIENCING INTERMITTENTLY OUT OF RANGE IMPEDANCE VALUES AS WELL AS A SIGNIFICANT DECREMENT IN PERFORMANCE. TESTING SHOWED THAT THE DEVICE WAS NOT FUNCTIONING. SURGERY TO EXPLANT THE PATIENT'S C1 DEVICE HAS BEEN SCHEDULED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CLARION | COCHLEAR IMPLANT | MCM | ADVANCED BIONICS, LLC | AB-5100R |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |