BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUCLEUS 5 WITH CONTOUR ADVANCE ELECTRODE

    MDR report key: 2405218 · Received December 23, 2011

    Report

    Report Number
    2405218
    Event Type
    Malfunction
    Date Received
    December 23, 2011
    Date of Event
    November 16, 2011
    Report Date
    December 21, 2011
    Manufacturer
    COCHLEAR AMERICAS INC
    Product Code
    MCM
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT WITH A HISTORY OF SENSORINEURAL HEARING LOSS, WHO UNDERWENT RIGHT COCHLEAR IMPLANTATION EARLIER IN 2011 (APPROX 8 MONTHS AGO), WITH A COCHLEAR CORPORATION CI512 DEVICE. RECENTLY, HE DEVELOPED A DEVICE FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NUCLEUS 5 WITH CONTOUR ADVANCE ELECTRODE IMPLANT, COCHLEAR MCM COCHLEAR AMERICAS INC CI512 *

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR