FDA Adverse Event
Malfunction
Summary report: N
NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM
MDR report key: 1082092
·
Received July 25, 2008
Report
- Report Number
- 6000034-2008-00406
- Event Type
- Malfunction
- Date Received
- July 25, 2008
- Date of Event
- January 16, 2007
- Report Date
- June 24, 2008
- Manufacturer
- COCHLEAR LTD.
- Product Code
- MCM
- PMA / PMN Number
- 840024
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THIS REPORT WAS FILED ON JULY 24, 2008.
Description of Event or Problem · 1
PER THE AUDIOLOGIST, THE ELECTRODE ARRAY OF THE PT'S DEVICE WAS PARTIALLY INSERTED AT THE INITIAL IMPLANT SURGERY. IN 2007, THE PT REPORTED INTERMITTENCIES AND POOR SOUND QUALITY WHEN USING THE DEVICE. RESULTS OF AN INTEGRITY TEST DONE IN 2007, WERE CONSISTENT WITH NORMAL RECEIVER/STIMULATOR FUNCTION WITH TWO FAULTY ELECTRODES. REPROGRAMMING THE SOUND PROCESSOR WAS RECOMMENDED. THE PT'S DEVICE WAS EXPLANTED EIGHT 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 22 CHANNEL COCHLEAR IMPLANT SYSTEM | MCM | COCHLEAR LTD. | CI22M | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |