FDA Adverse Event
Malfunction
Summary report: N
NUCLEOUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
MDR report key: 523134
·
Received February 12, 2004
Report
- Report Number
- 6000034-2004-00044
- Event Type
- Malfunction
- Date Received
- February 12, 2004
- Date of Event
- January 16, 2004
- Report Date
- February 11, 2004
- Manufacturer
- COCHLEAR LTD.
- Product Code
- MCM
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- ME, US
- Reporter Occupation
- AUDIOLOGIST
Narratives
Description of Event or Problem · 1
AFTER A BLOW TO THE HEAD, THIS PATIENT STOPPED RESPONDING TO THE COCHLEAR IMPLANT. USING THE APPROPRIATE DIAGNOSTIC EQUIPMENT, IT WAS DETERMINED THAT THE DEVICE IS NOT FUNCTIONING ACCORDING TO MFR'S SPECIFICATIONS. EXPLANTATION/REIMPLANTATION SURGERY IS YET TO BE SCHEDULED. THE HEALTHCARE PROFESSIONAL HAS BEEN INFORMED THAT THE EXPLANTED DEVICES SHOULD BE RETURNED TO COCHLEAR LTD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NUCLEOUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM | 24 CHANNEL COCHLEAR IMPLANT | MCM | COCHLEAR LTD. | CI24M | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 7 YR | Required Intervention |