FDA Adverse Event
Malfunction
Summary report: N
HIRES 90K
MDR report key: 1083060
·
Received March 7, 2008
Report
- Report Number
- 3006556115-2008-00090
- Event Type
- Malfunction
- Date Received
- March 7, 2008
- Date of Event
- February 8, 2008
- Report Date
- February 8, 2008
- Manufacturer
- ADVANCED BIONICS, LLC
- Product Code
- MCM
- PMA / PMN Number
- P960058
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- AUDIOLOGIST
Narratives
Description of Event or Problem · 1
IT WAS REPORTED TO THE COMPANY THAT THE PATIENT HIT HIS HEAD AT SCHOOL AND EXPERIENCED SOUND QUALITY ISSUES WITH HIS DEVICE. TESTING PERFORMED BY ADVANCED BIONICS REP SHOWED THAT THE DEVICE WAS FUNCTIONING. HOWEVER, THE PROBLEM WAS NOT SOLVED. SURGERY TO EXPLANT THE PATIENTS DEVICE WILL BE SCHEDULED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HIRES 90K | COCHLEAR IMPLANT | MCM | ADVANCED BIONICS, LLC | CI-1400-02H |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |