FDA Adverse Event
Malfunction
Summary report: N
HIRES 90K
MDR report key: 688927
·
Received March 15, 2006
Report
- Report Number
- 2029203-2006-00103
- Event Type
- Malfunction
- Date Received
- March 15, 2006
- Date of Event
- February 13, 2006
- Report Date
- March 15, 2006
- Manufacturer
- ADVANCED BIONICS CORP.
- Product Code
- MCM
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- AUDIOLOGIST
Narratives
Description of Event or Problem · 1
THE PT REPORTEDLY EXPERIENCED INTERMITTENCIES FOLLOWED BY LOSS OF LOCK. ON FEBRUARY 13, 2006, THE PT WAS SEEN BY A COMPANY REPRESENTATIVE FOR DEVICE EVALUATION. TESTING PERFORMED CONFIRMED THAT THE PT'S DEVICE WAS NO LONGER FUNCTIONING. SURGERY TO EXPLANT THE PT'S DEVICE HAS BEEN SCHEDULED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HIRES 90K | COCHLEAR IMPLANT | MCM | ADVANCED BIONICS CORP. | CI-1400-01 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 80 YR |