FDA Adverse Event
Malfunction
Summary report: N
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
MDR report key: 2111979
·
Received June 2, 2011
Report
- Report Number
- 6000034-2011-00386
- Event Type
- Malfunction
- Date Received
- June 2, 2011
- Date of Event
- May 16, 2011
- Report Date
- February 6, 2012
- Manufacturer
- COCHLEAR LTD.
- Product Code
- MCM
- PMA / PMN Number
- 970051
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- AUDIOLOGIST
Narratives
Additional Manufacturer Narrative · 1
DEVICE IS NOT AVAILABLE FOR ANALYSIS. THIS REPORT IS FILED (B)(4) 2012. DEVICE NOT AVAILABLE FOR ANALYSIS.
Additional Manufacturer Narrative · 1
(B)(4)
Description of Event or Problem · 1
PER THE CLINIC, THE PATIENT'S RECHARGEABLE BATTERY OVERHEATED WHEN CONNECTED TO AN EXTERNAL ACCESSORY DEVICE. THERE WERE NO ALLEGATIONS OF PATIENT INJURY AND THE DEVICE HAS BEEN REMOVED FROM SERVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM | MCM | MCM | COCHLEAR LTD. | N/A | N/A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 6 YR | Required Intervention |