FDA Adverse Event
Malfunction
Summary report: N
CLARION
MDR report key: 1021443
·
Received March 24, 2008
Report
- Report Number
- 3006556115-2008-00161
- Event Type
- Malfunction
- Date Received
- March 24, 2008
- Date of Event
- March 10, 2008
- Report Date
- March 10, 2008
- Manufacturer
- ADVANCED BIONICS LLC
- Product Code
- MCM
- PMA / PMN Number
- P960058
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THE PATIENT REPORTEDLY EXPERIENCED A LOSS OF LOCK WITH THE DEVICE. EXTERNAL EQUIPMENT WAS EXCHANGED AND PROGRAMMING ADJUSTMENTS WERE MADE, HOWEVER, THE PROBLEM WAS NOT RESOLVED. TESTING PERFORMED ON THE DEVICE SHOWED THAT IT WAS NOT FUNCTIONING. SURGERY TO EXPLANT THE PATIENT'S DEVICE HAS BEEN SCHEDULED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CLARION | COCHELAR IMPLANT | MCM | ADVANCED BIONICS LLC | AB-5100L | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |