FDA Adverse Event
Malfunction
Summary report: N
NUCLEUSCI512 COCHLEAR IMPLANT WITH CONTOUR ADVANCE ELECTRODE
MDR report key: 7250551
·
Received February 8, 2018
Report
- Report Number
- 6000034-2018-00309
- Event Type
- Malfunction
- Date Received
- February 8, 2018
- Report Date
- February 20, 2018
- Manufacturer
- COCHLEAR LTD
- Product Code
- MCM
- UDI-DI
- 09321502014564
- PMA / PMN Number
- P970051
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THIS REPORT IS SUBMITTED ON FEBRUARY 08, 2018.
Description of Event or Problem · 1
IT WAS REPORTED THE DEVICE WAS EXPLANTED (DATE NOT REPORTED) DUE TO AN UNKNOWN REASON. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT HAS NOT BEEN MADE AVAILABLE AS OF THE DATE OF THIS REPORT, FEBRUARY 08, 2018.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 97633 | NUCLEUSCI512 COCHLEAR IMPLANT WITH CONTOUR ADVANCE ELECTRODE | NUCLEUS 24 COCHLEAR IMPLANT SYSTEM | MCM | COCHLEAR LTD | CI512 | NA | 09321502014564 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |