FDA Adverse Event
Malfunction
Summary report: N
COCHLEAR NUCLEUS FREEDOM
MDR report key: 4272491
·
Received October 30, 2014
Report
- Report Number
- 4272491
- Event Type
- Malfunction
- Date Received
- October 30, 2014
- Date of Event
- July 9, 2014
- Report Date
- October 29, 2014
- Manufacturer
- COCHLEAR AMERICAS, INC.
- Product Code
- MCM
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- MI, US
Narratives
Description of Event or Problem · 1
RIGHT COCHLEAR IMPLANT DEVICE FAILURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 694657 | COCHLEAR NUCLEUS FREEDOM | IMPLANT, COCHLEAR | MCM | COCHLEAR AMERICAS, INC. | CI512 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 9 YR | NOT APPLICABLE. |