FDA Adverse Event
Malfunction
Summary report: N
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
MDR report key: 1031664
·
Received April 18, 2008
Report
- Report Number
- 6000034-2008-00205
- Event Type
- Malfunction
- Date Received
- April 18, 2008
- Date of Event
- January 7, 2008
- Report Date
- April 18, 2008
- Manufacturer
- COCHLEAR LTD.
- Product Code
- MCM
- 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 PT HAD NOT PERFORMED WELL WITH THE COCHLEAR IMPLANT SYSTEM. NO SPECIFIC EVENT OR PROBLEM (TRAUMA, MEDICATION, ILLNESS, ETC.) HAD BEEN REPORTED. THE RESULTS OF AN INTEGRITY TEST DONE IN EARLY 2007 SHOWED MULTIPLE FAULTY ELECTRODES. THE FAULTY ELECTRODES WERE DEACTIVATED IN THE PT'S SOUND PROCESSOR. THIS DID NOT SOLVE THE PROBLEM. THE PT'S DEVICE WAS EXPLANTED IN 2008, AND A NEW DEVICE WAS REIMPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM | COCHLEAR IMPLANT | MCM | COCHLEAR LTD. | CI24R(ST) | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |