FDA Adverse Event
Injury
Summary report: N
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
MDR report key: 1297032
·
Received January 19, 2009
Report
- Report Number
- 6000034-2009-00057
- Event Type
- Injury
- Date Received
- January 19, 2009
- Date of Event
- December 24, 2008
- Report Date
- January 8, 2009
- Manufacturer
- COCHLEAR LTD.
- Product Code
- MCM
- PMA / PMN Number
- 970051
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THIS REPORT FILED ON JANUARY 19, 2009.
Description of Event or Problem · 1
PER THE RETURNED PAPERWORK, THE PATIENT REPORTED FACIAL NERVE STIMULATION WHEN USING THE COCHLEAR IMPLANT SYSTEM. THERE WAS NO INTEGRITY TEST PERFORMED BY COCHLEAR STAFF PRIOR TO THE EXPLANT SURGERY. THE PATIENT'S DEVICE WAS EXPLANTED IN 2008, AND A NEW DEVICE WAS REIMPLANTED DURING THE SAME SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM | MCM | COCHLEAR LTD. | CI24M | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 10 YR | Required Intervention |