FDA Adverse Event
Malfunction
Summary report: N
HIRES 90K
MDR report key: 2003126
·
Received February 15, 2011
Report
- Report Number
- 3006556115-2011-00051
- Event Type
- Malfunction
- Date Received
- February 15, 2011
- Date of Event
- January 25, 2011
- Report Date
- January 25, 2011
- Manufacturer
- ADVANCED BIONICS LLC
- Product Code
- MCM
- PMA / PMN Number
- P960058
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- UNKNOWN
Narratives
Description of Event or Problem · 1
THE COMPANY WAS INFORMED THAT THE PATIENT'S DEVICE HAD OPEN ELECTRODES. THE PATIENT'S DEVICE WAS EXPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HIRES 90K | COCHLEAR IMPLANT | MCM | ADVANCED BIONICS LLC | CI-1400-02H | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 7 YR |