FDA Adverse Event
Malfunction
Summary report: N
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
MDR report key: 1032399
·
Received April 17, 2008
Report
- Report Number
- 6000034-2008-00202
- Event Type
- Malfunction
- Date Received
- April 17, 2008
- Date of Event
- June 20, 2007
- Report Date
- April 17, 2008
- 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.
Description of Event or Problem · 1
PER THE AUDIOLOGIST, THE PARENTS OF THE PATIENT REPORTED THE PATIENT WAS NOT HEARING WELL WITH THE COCHLEAR IMPLANT SYSTEM. RESULTS OF AN INTEGRITY TEST DONE IN 2007 WERE CONSISTENT WITH NORMAL RECEIVER/STIMULATOR FUNCTION WITH TWO SHORT CIRCUIT ELECTRODES AND MULTIPLE ELECTRODE ANOMALIES. THE PATIENT'S DEVICE WAS EXPLANTED ON SIX MONTHS LATER, AND A NEW DEVICE WAS REIMPLANTED DURING THE SAME SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM | COCHLEAR IMPLANT | MCM | COCHLEAR LTD. | CI24R(CS) | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |