FDA Adverse Event
Malfunction
Summary report: N
NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM FOR ADULTS
MDR report key: 210778
·
Received February 19, 1999
Report
- Report Number
- 6000034-1999-00020
- Event Type
- Malfunction
- Date Received
- February 19, 1999
- Date of Event
- February 9, 1999
- Report Date
- February 19, 1999
- Manufacturer
- COCHLEAR LTD.
- Product Code
- MCM
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SW
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THE PT REPORTED NO LONGER HEARING ON SEVERAL ELECTRODES. USING THE APPROPRIATE DIAGNOSITC EQUIPMENT, IT WAS DETERMINED THAT THE DEVICE IS NOT FUNCTIONING ACCORDING TO MANUFACTURER'S SPECIFICATIONS. EXPLANTATION/REIMPLANTATION SURGERY HAS BEEN SCHEDULED FOR 2/19/1999.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM FOR ADULTS Implant | 22 CHANNEL COCHLEAR IMPLANT FOR ADULTS | MCM | COCHLEAR LTD. | CI22M | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 16 YR |