BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COCHLEAR NUCLEUS CI512

    MDR report key: 3879437 · Received May 29, 2014

    Report

    Report Number
    3879437
    Event Type
    Malfunction
    Date Received
    May 29, 2014
    Date of Event
    February 3, 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

    Narratives

    Description of Event or Problem · 1

    THIS PATIENT WITH AIED (AUTOIMMUNE INNER EAR DISEASE) S/P RIGHT SINGULAR NEURECTOMY MET AUDIOMETRIC CRITERIA FOR COCHLEAR IMPLANTATION. COCHLEAR IMPLANTATION USING THE NUCLEUS CI512 DEVICE WITH CONTOUR ADVANCE ELECTRODE WAS PERFORMED 3 YEARS AGO. DEVICE WITH SERIAL NUMBER WAS IMPLANTED AT THAT OPERATION. HE RECENTLY BEGAN TO SUFFER INTERMITTENT LOSS OF HEARING BENEFIT AND INCREASING POWER REQUIREMENTS, SIGNS OF AN IMPENDING HARD FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    316272 COCHLEAR NUCLEUS CI512 IMPLANT, COCHLEAR MCM COCHLEAR AMERICAS, INC. CI512 *

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR NOT APPLICABLE.