BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COCHLEAR NUCLEUS W/CONTOUR ADVANCED

    MDR report key: 3026874 · Received March 17, 2013

    Report

    Report Number
    3026874
    Event Type
    Malfunction
    Date Received
    March 17, 2013
    Date of Event
    January 18, 2013
    Report Date
    March 11, 2013
    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 UNDERWENT COCHLEAR IMPLANTATION IN THE RIGHT EAR WITH A NUCLEUS FREEDOM DEVICE IN 2006. HE SUBSEQUENTLY UNDERWENT IMPLANTATION OF THE LEFT EAR WITH A NUCLEUS CI512 DEVICE APPROXIMATELY FOUR YEARS LATER. THE EXTERNAL PROCESSOR COMPONENTS WERE REPLACED, HOWEVER, THE DEVICE IS NO LONGER FUNCTIONING AT ALL. THE NUCLEUS 512 DEVICES WERE RECALLED ABOUT ONE YEAR AGO DUE TO AN INCREASED FAILURE RATE, AND THIS HAS BEEN DEEMED A HARD FAILURE OF THE INTERNAL DEVICE.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?LEFT EXPLANT/RE-IMPLANT COCHLEAR IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    111792 COCHLEAR NUCLEUS W/CONTOUR ADVANCED IMPLANT, COCHLEAR MCM COCHLEAR AMERICAS, INC. NUCLEUS 512 *

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR