BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLARION II HI-RES COCHLEAR IMPLANT

    MDR report key: 751195 · Received July 30, 2005

    Report

    Report Number
    MW1036203
    Event Type
    Injury
    Date Received
    July 30, 2005
    Date of Event
    July 11, 2005
    Report Date
    July 30, 2005
    Manufacturer
    ADVANCED BIONICS
    Product Code
    MCM
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    COCHLEAR IMPLANT DYSFUNCTION, CLARION II BTE HI-RES, INTERMITTENT BUT FREQUENT. LOSS OF SOUND. UP TO DATE PROBLEM NOT KNOWN, UNDER INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLARION II HI-RES COCHLEAR IMPLANT COCHLEAR IMPLANT MCM ADVANCED BIONICS CI-1400-01 *

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Disability