FDA Adverse Event
Injury
Summary report: N
HIRES 90K
MDR report key: 1961364
·
Received January 6, 2011
Report
- Report Number
- 3006556115-2010-00682
- Event Type
- Injury
- Date Received
- January 6, 2011
- Date of Event
- November 19, 2010
- Report Date
- December 17, 2010
- Manufacturer
- ADVANCED BIONICS LLC
- Product Code
- MCM
- PMA / PMN Number
- P960058
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- EC
- Reporter Occupation
- UNKNOWN
Narratives
Description of Event or Problem · 1
THE COMPANY WAS INFORMED THAT DURING INITIAL IMPLANTATION, THE PT REPORTEDLY EXPERIENCED A CSF GUSHER CAUSED BY INSERTION OF ELECTRODE ARRAY AND ELECTRODE PLACEMENT IN THE VESTIBULE. THE PT'S DEVICE WAS EXPLANTED. PT COULD NOT BE REIMPLANTED DUE TO CSF GUSHER. THERE ARE NO PLANS FOR REIMPLANTATION AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HIRES 90K | COCHLEAR IMPLANT | MCM | ADVANCED BIONICS LLC | CI-1400-01 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 28 MO | Required Intervention |