FDA Adverse Event
Malfunction
Summary report: N
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
MDR report key: 818717
·
Received February 1, 2007
Report
- Report Number
- 6000034-2007-00038
- Event Type
- Malfunction
- Date Received
- February 1, 2007
- Date of Event
- December 25, 2006
- Report Date
- January 31, 2007
- Manufacturer
- COCHLEAR LTD.
- Product Code
- MCM
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- AUDIOLOGIST
Narratives
Additional Manufacturer Narrative · 1
THIS TYPE OF EVENT IS ADDRESSED IN THE DEVICE LABELING.
Description of Event or Problem · 1
PER THE AUDIOLOGIST'S REPORT, THIS PATIENT EXPERIENCED INTERMITTENT DEVICE FUNCTION STARTING THE WEEK OF 12/25/2006. ON 1/08/2007, THE PATIENT FELL AND HIT HIS HEAD. AFTER THIS INCIDENT, HE COULD NO LONGER HEAR. TESTING SHOWED THAT ALL OF THE IMPEDENCES WERE HIGH. EXPLANTATION/REIMPLANTATION SURGERY WAS SCHEDULED FOR 2007.
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) | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 5 YR | Required Intervention |