FDA Adverse Event
Malfunction
Summary report: N
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
MDR report key: 713039
·
Received November 22, 2005
Report
- Report Number
- 6000034-2005-00335
- Event Type
- Malfunction
- Date Received
- November 22, 2005
- Date of Event
- August 19, 2005
- Report Date
- November 22, 2005
- Manufacturer
- COCHLEAR LTD.
- Product Code
- MCM
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
DURING COCHLEAR IMPLANT SURGERY, NORMAL RESPONSE MEASURED ON 5 ELECTRODES OF THIS PT'S IMPLANT. HOWEVER DURING INITIAL ACTIVATION, NO RESPONSE FROM THE IMPLANT WAS OBTAINED AND THE PT DID NOT RESPOND TO STIMULATION. DURING AN INTERGRITY TEST ON 08/19/2005, IMPLANT FAILURE WAS CONFIRMED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM | COCHLEAR IMPLANT | MCM | COCHLEAR LTD. | CI24R(CA) | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 3 YR | Required Intervention |