FDA Adverse Event
Malfunction
Summary report: N
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
MDR report key: 3033452
·
Received April 3, 2013
Report
- Report Number
- 6000034-2013-00634
- Event Type
- Malfunction
- Date Received
- April 3, 2013
- Date of Event
- March 12, 2013
- Report Date
- May 9, 2013
- 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
THIS DEVICE IS NOT AVAILABLE FOR ANALYSIS.THIS REPORT IS FILED JULY 1, 2013.
Additional Manufacturer Narrative · 1
(B)(4)
Description of Event or Problem · 1
PER THE CLINIC, THE PATIENT REPORTED THAT HE RECHARGEABLE BATTERY AND PROCESSOR BECAME HOT WITH DEVICE USE. IT HAS BEEN REQUESTED THAT THE PROCESSOR AND BATTERY BE REMOVED FROM SERVICE AND RETURNED TO THE MANUFACTURER FOR ANALYSIS. REPLACEMENT EQUIPMENT HAS BEEN SENT TO THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 135594 | NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM | PRODUCT CODE: MCM | MCM | COCHLEAR LTD. | CP800 | N/A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 6 YR | Required Intervention |