FDA Adverse Event
Malfunction
Summary report: N
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
MDR report key: 477584
·
Received August 13, 2003
Report
- Report Number
- 6000034-2003-00180
- Event Type
- Malfunction
- Date Received
- August 13, 2003
- Date of Event
- August 8, 2003
- Report Date
- August 13, 2003
- Manufacturer
- COCHLEAR LTD.
- Product Code
- MCM
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THIS PT EXPERIENCED A BLOW TO THE HEAD AND SUDDEN LOSS OF SOUND. USING THE APPROPRIATE DIAGNOSTIC EQUIPMENT, IT WAS DETERMINED THAT THE DEVICE IS NOT FUNCTIONING ACCORDING TO MFR'S SPECS. EXPLANTATION/REIMPLANTATION SURGERY IS YET TO BE SCHEDULED. THE HEALTHCARE PROFESSIONAL HAS BEEN INFORMED THAT THE EXPLANTED DEVICE SHOULD BE RETURNED TO COCHLEAR LTD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM | 24 CHANNEL COCHLEAR IMPLANT | MCM | COCHLEAR LTD. | CI24M | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 7 YR |