FDA Adverse Event Malfunction Summary report: N

NUCLEUS CI512 COCHLEAR IMPLANT WITH CONTOUR ADVANCE ELECTRODE

MDR report key: 2960153 · Received February 13, 2013

Report

Report Number
6000034-2012-01172
Event Type
Malfunction
Date Received
February 13, 2013
Date of Event
June 12, 2012
Report Date
June 12, 2012
Manufacturer
COCHLEAR LTD
Product Code
MCM
UDI-DI
09321502014564
PMA / PMN Number
P970051
Product Problem
Yes
Report Source
Manufacturer report
Reporter Location
SZ
Reporter Occupation
OTHER

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
64099 NUCLEUS CI512 COCHLEAR IMPLANT WITH CONTOUR ADVANCE ELECTRODE NUCLEUS 24 COCHLEAR IMPLANT SYSTEM MCM COCHLEAR LTD CI512 NA 09321502014564

Patients

Seq Age Sex Outcome Treatment
1 8 YR Male Other