FDA Adverse Event
Malfunction
Summary report: N
CLARION
MDR report key: 1781208
·
Received July 27, 2010
Report
- Report Number
- 3006556115-2010-00346
- Event Type
- Malfunction
- Date Received
- July 27, 2010
- Date of Event
- July 6, 2010
- Report Date
- July 6, 2010
- Manufacturer
- ADVANCED BIONICS LLC
- Product Code
- MCM
- PMA / PMN Number
- P960058
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- AUDIOLOGIST
Narratives
Description of Event or Problem · 1
THE PT REPORTEDLY EXPERIENCED LOSS OF LOCK WITH HER INTERNAL DEVICE. EXTERNAL EQUIPMENT WAS EXCHANGED AND PROGRAMMING ADJUSTMENTS WERE MADE; HOWEVER, THIS DID NOT RESOLVE THE ISSUE. SURGERY TO EXPLANT THE PT'S DEVICE HAS BEEN SCHEDULED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CLARION | COCHLEAR IMPLANT | MCM | ADVANCED BIONICS LLC | AB-5100H | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 84 YR |