FDA Adverse Event
Malfunction
Summary report: N
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
MDR report key: 1122146
·
Received August 14, 2008
Report
- Report Number
- 6000034-2008-00448
- Event Type
- Malfunction
- Date Received
- August 14, 2008
- Date of Event
- May 1, 2008
- Report Date
- July 16, 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 BUZZING SOUND WHEN USING THE COCHLEAR IMPLANT SYSTEM. IMPEDANCE TESTING AT THE HOSPITAL SHOWED ABNORMAL LEVELS. REPROGRAMMING THE SOUND PROCESSOR DID NOT ALLEVIATE THE PROBLEM. RESULTS OF AN INTEGRITY TEST DONE IN 2008 WERE CONSISTENT WITH NORMAL RECEIVER/STIMULATOR FUNCTION WITH ANOMALIES ON MULTIPLE ELECTRODES. THESE ELECTRODES WERE DEACTIVATED BUT DID NOT SOLVE THE PROBLEM. EXPLANTATION/REIMPLANTATION IS PLANNED, BUT NO DATE HAD BEEN SET AS OF THE DATE OF THIS REPORT, THE FOLLOWING MONTH.
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 | 4 YR | Required Intervention |