FDA Adverse Event
Injury
Summary report: N
HIRES 90K
MDR report key: 1357776
·
Received April 3, 2009
Report
- Report Number
- 3006556115-2009-00147
- Event Type
- Injury
- Date Received
- April 3, 2009
- Date of Event
- February 23, 2009
- Report Date
- March 4, 2009
- Manufacturer
- ADVANCED BIONICS LLC.
- Product Code
- MCM
- PMA / PMN Number
- P960058
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THE COMPANY WAS INFORMED THAT THREE HOURS AFTER THE DEVICE WAS IMPLANTED, THE PATIENT HAD A FACIAL NERVE WEAKNESS, WHICH INVOLVED MOST OF THE SIDE OF THE FACE. THE CENTER REPORTED THAT EYE CLOSURE AND DEVIATION OF THE ANGLE OF THE MOUTH WAS PRESENT WHILE SMILING. THE EYE WAS TREATED WITH HIGH DOSE OF CORTICOSTEROIDS FOR FIVE DAYS. GRADUAL IMPROVEMENT WAS EVIDENT. THE CENTER IS INVESTIGATING DOING A FACIAL NERVE DECOMPRESSION, WHICH WOULD REQUIRE EXPLANTING THE PATIENT'S DEVICE. ONCE MORE INFORMATION IS AVAILABLE, A SUPPLEMENT REPORT WILL BE SUBMITTED.
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 | 4 YR | Required Intervention |