FDA Adverse Event
Malfunction
Summary report: N
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
MDR report key: 2801866
·
Received October 23, 2012
Report
- Report Number
- 6000034-2012-02016
- Event Type
- Malfunction
- Date Received
- October 23, 2012
- Report Date
- July 25, 2013
- 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
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
THIS DEVICE IS NOT AVAILABLE FOR ANALYSIS. (B)(4).
Description of Event or Problem · 1
PER THE CLINIC, THE TRANSMITTING COIL OF THE SOUND PROCESSOR WAS REPORTED TO HAVE BECOME HOT. NO REPORTS OF PATIENT INJURY ARE ASSOCIATED WITH THIS EVENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT HAS NOT BEEN PROVIDED AS OF THE DATE OF THIS REPORT, (B)(4) 2012.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM | PRODUCT CODE: MCM | MCM | COCHLEAR LTD. | Z207515 | N/A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |