FDA Adverse Event
Malfunction
Summary report: N
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM.
MDR report key: 2242039
·
Received September 9, 2011
Report
- Report Number
- 6000034-2011-00682
- Event Type
- Malfunction
- Date Received
- September 9, 2011
- Date of Event
- August 23, 2011
- Report Date
- August 23, 2011
- Manufacturer
- COCHLEAR LTD
- Product Code
- MCM
- PMA / PMN Number
- 970051
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PER THE CLINIC, THE PATIENT REPORTED THAT THE PROCESSOR BECAME HOT WITH RECHARGEABLE BATTERIES. THE BATTERIES HAVE BEEN TAKEN OUT OF SERVICE AND HAVE BEEN REQUESTED TO BE RETURNED FOR ANALYSIS. THERE WERE NO ALLEGATIONS OF PATIENT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM. | MCM | MCM | COCHLEAR LTD | N/A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 3 YR | Required Intervention |