FDA Adverse Event
Malfunction
Summary report: N
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
MDR report key: 2231924
·
Received September 1, 2011
Report
- Report Number
- 6000034-2011-00645
- Event Type
- Malfunction
- Date Received
- September 1, 2011
- Date of Event
- July 18, 2011
- Report Date
- September 16, 2011
- Manufacturer
- COCHLEAR LTD.
- Product Code
- MCM
- PMA / PMN Number
- 970051
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
(B)(4). IMPLANTED DEVICE REMAINS.
Additional Manufacturer Narrative · 1
PER PATIENT'S SURGEON, THE DEVICE WAS EXPLANTED ON (B)(6) 2011; DURING THE SAME SURGERY THE PATIENT WAS REIMPLANTED WTIH A NEW DEVICE. (B)(4).
Description of Event or Problem · 1
PER THE CLINIC, THE PATIENT EXPERIENCED A SUDDEN LOSS OF SOUND FOLLOWING AN ALLEGED ASSAULT. REPROGRAMMING ATTEMPTS WERE MADE; HOWEVER, THE ISSUE COULD NOT BE RESOLVED. THE IMPLANTED DEVICE REMAINS. IT IS UNKNOWN IF THERE ARE PLANS TO EXPLANT THE DEVICE AND TO REIMPLANT THE PATIENT WITH ANOTHER DEVICE AS OF THE DATE OF THIS REPORT, (B)(6), 2011.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM | MCM, PRODUCT CODE: MCM | MCM | COCHLEAR LTD. | CI512 | N/A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 21 YR | Required Intervention |