FDA Adverse Event
Injury
Summary report: N
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
MDR report key: 2736137
·
Received September 7, 2012
Report
- Report Number
- 6000034-2012-01728
- Event Type
- Injury
- Date Received
- September 7, 2012
- Date of Event
- August 27, 2012
- Report Date
- September 11, 2013
- Manufacturer
- COCHLEAR LTD.
- Product Code
- MCM
- PMA / PMN Number
- 970051
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OK, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THIS DEVICE IS NOT AVAILABLE FOR ANALYSIS. THIS REPORT IS FILED SEPTEMBER 25, 2013.
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PER THE CLINIC, THE SOUND PROCESSOR WAS FOUND TO HAVE BECOME HOT WHEN USED WITH A RECHARGEABLE BATTERY. NO REPORTS OF PATIENT INJURY ARE ASSOCIATED WITH THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM | PRODUCT CODE: MCM | MCM | COCHLEAR LTD. | CP800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 8 YR | Required Intervention |