FDA Adverse Event
Malfunction
Summary report: N
HIRES 90K IMPLANT
MDR report key: 2913487
·
Received January 9, 2013
Report
- Report Number
- 3006556115-2012-00612
- Event Type
- Malfunction
- Date Received
- January 9, 2013
- Date of Event
- December 19, 2012
- Report Date
- December 19, 2012
- Manufacturer
- ADVANCED BIONICS LLC
- Product Code
- MCM
- PMA / PMN Number
- P960058
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- AUDIOLOGIST
Narratives
Description of Event or Problem · 1
THE PATIENT REPORTEDLY EXPERIENCED LOSS OF LOCK BETWEEN THE EXTERNAL EQUIPMENT AND THE COCHLEAR IMPLANT. EXTERNAL EQUIPMENT WAS EXCHANGED; BUT, THE ISSUE WAS NOT RESOLVED. DEVICE TESTING REVEALED ABNORMAL DEVICE FUNCTION. SURGERY TO EXPLANT THE PATIENT'S DEVICE WILL BE SCHEDULED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 13096 | HIRES 90K IMPLANT | COCHLEAR IMPLANT | MCM | ADVANCED BIONICS LLC | CI-1400-01 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 12 YR |