FDA Adverse Event
Malfunction
Summary report: N
NUCLEUS CHANNEL COCHLEAR IMPLANT SYSTEM
MDR report key: 746739
·
Received October 28, 2005
Report
- Report Number
- 6000034-2005-00320
- Event Type
- Malfunction
- Date Received
- October 28, 2005
- Date of Event
- September 21, 2005
- Report Date
- October 28, 2005
- Manufacturer
- COCHLEAR LTD.
- Product Code
- MCM
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THIS TYPE OF EVENT IS ADDRESSED IN THE DEVICE LABELING CODE #1738.
Description of Event or Problem · 1
AFTER 2 1/2 YEARS OF COCHLEAR IMPLANT USE, THIS PT REPORTED POOR SOUND QUALITY AND FLUCTUATING VOLUME. EVEN NUMBERED ELECTRODES WERE DEACTIVATED IN THE SPEECH PROCESSOR PROGRAM. THIS IMPROVED THE SOUND QUALITY FOR SOME TIME. ON 9/21/2005, SEVERAL FAULTY ELECTRODES WERE DISCOVERED THROUGH INTEGRITY TESTING. REPROGRAMMING DID NOT RESOLVE THE PATIENT'S CONTINUED REPORT OF POOR SOUND QUALITY. THE CLINIC HAS DECIDED TO EXPLANT THE DEVICE AND REIMPLANT THE PATIENT WITH A NEW ONE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NUCLEUS CHANNEL COCHLEAR IMPLANT SYSTEM | COCHLEAR IMPLANT | MCM | COCHLEAR LTD. | CI24R(CS) | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 55 YR | Required Intervention |