FDA Adverse Event
Malfunction
Summary report: N
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
MDR report key: 1080564
·
Received July 17, 2008
Report
- Report Number
- 6000034-2008-00389
- Event Type
- Malfunction
- Date Received
- July 17, 2008
- Date of Event
- March 20, 2008
- Report Date
- June 18, 2008
- Manufacturer
- COCHLEAR LTD.
- Product Code
- MCM
- PMA / PMN Number
- 970051
- 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.
Description of Event or Problem · 1
PER THE AUDIOLOGIST, THE PATIENT'S PARENTS REPORTED THE PATIENT WAS HEARING INTERMITTENTLY WITH THE COCHLEAR IMPLANT SYSTEM. EXCHANGING EQUIPMENT DID NOT ALLEVIATE THE PROBLEM. RESULTS OF TWO INTEGRITY TESTS REVIEWED IN 2008 AND ABOUT TWO MONTHS LATER WERE CONSISTENT WITH NORMAL RECEIVER/STIMULATOR FUNCTION WITH MULTIPLE ELECTRODE ANOMALIES. A REPEAT INTEGRITY TEST DONE IN THE FOLLOWING MONTH WAS CONSISTENT WITH THE PREVIOUS RESULTS. EXPLANTATION/REIMPLANTATION PLANS HAD NOT BEEN REPORTED 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 | COCHLEAR IMPLANT | MCM | COCHLEAR LTD. | CI24RE(CA) | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |