FDA Adverse Event
Malfunction
Summary report: N
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
MDR report key: 1080563
·
Received July 17, 2008
Report
- Report Number
- 6000034-2008-00391
- Event Type
- Malfunction
- Date Received
- July 17, 2008
- Date of Event
- November 22, 2007
- Report Date
- June 19, 2008
- Manufacturer
- COCHLEAR LTD.
- Product Code
- MCM
- PMA / PMN Number
- 970051
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THIS TYPE OF EVENT IS ADDRESSED IN THE DEVICE LABELING.
Description of Event or Problem · 1
PER THE AUDIOLOGIST, THE PATIENT REPORTED A DECREASE IN SOUND QUALITY WHEN USING THE COCHLEAR IMPLANT SYSTEM. EXCHANGING EXTERNAL EQUIPMENT DID NOT SOLVE THE PROBLEM. RESULTS OF AN INTEGRITY TEST DONE IN 2007 WERE CONSISTENT WITH NORMAL RECEIVER/STIMULATOR FUNCTION WITH MULTIPLE FAULTY AND ANOMALOUS ELECTRODES. THE IDENTIFIED ELECTRODES WERE DEACTIVATED IN THE SOUND PROCESSING PROGRAM. RESULTS OF AN INTEGRITY TEST DONE IN 2008 WERE CONSISTENT WITH THE RESULTS OF THE FIRST INTEGRITY TEST. REIMPLANTATION HAS BEEN RECOMMENDED BUT HAD NOT BEEN SCHEDULED AT THE TIME THIS REPORT WAS FILED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM | MCM | COCHLEAR LTD. | CI24R(CS) | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |