FDA Adverse Event
Malfunction
Summary report: N
NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM FOR ADULTS
MDR report key: 209405
·
Received February 9, 1999
Report
- Report Number
- 6000034-1999-00014
- Event Type
- Malfunction
- Date Received
- February 9, 1999
- Date of Event
- November 13, 1998
- Report Date
- February 8, 1999
- Manufacturer
- COCHLEAR LTD.
- Product Code
- MCM
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- AUDIOLOGIST
Narratives
Description of Event or Problem · 1
THE PT REPORTED NOT HEARING ON THREE ELECTRODES ON 07/01/1997. THE ELECTRODES WERE DEACTIVATED, RESOLVING HER COMPLAINT. ON 11/13/1998 THE HEALTH CARE PROFESSIONAL REPORTED THE DEVICE HAD BEEN EXPLANTED ELECTIVELY. THE DEVICE WAS ANALYZED AND FOUND TO HAVE MALFUNCTION (DRAFT ANALYSIS ON 01/14/1999).
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 | 46 YR |