BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COCHLEAR NUCLEUS CI512

    MDR report key: 3871126 · Received May 29, 2014

    Report

    Report Number
    3871126
    Event Type
    Malfunction
    Date Received
    May 29, 2014
    Date of Event
    March 20, 2014
    Report Date
    May 29, 2014
    Manufacturer
    COCHLEAR AMERICAS INC.
    Product Code
    MCM
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    PATIENT IS WITH A HISTORY OF BILATERAL SENSORINEURAL HEARING LOSS WHO HAD PREVIOUSLY UNDERGONE RIGHT COCHLEAR IMPLANTATION. HER PERFORMANCE HAS BEEN POORER THAN EXPECTED, WITH TESTING SUGGESTING A FAILURE OF THE INTERNAL DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    317210 COCHLEAR NUCLEUS CI512 IMPLANT, COCHLEAR MCM COCHLEAR AMERICAS INC. CI512 *

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR NOT APPLICABLE.