BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLARION IMPLANT

    MDR report key: 3193148 · Received June 25, 2013

    Report

    Report Number
    3006556115-2013-00282
    Event Type
    Malfunction
    Date Received
    June 25, 2013
    Date of Event
    June 4, 2013
    Report Date
    June 4, 2013
    Manufacturer
    ADVANCED BIONICS, LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS LOSS OF SOUND, FOLLOWED BY LOSS OF LOCK BETWEEN THE PT'S INTERNAL DEVICE AND EXTERNAL EQUIPMENT. EXTERNAL EQUIPMENT WAS EXCHANGED AND PROGRAMMING ADJUSTMENTS WERE MADE; HOWEVER, LOCK COULD NOT BE ESTABLISHED. REVISION SURGERY HAS BEEN SCHEDULED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288745 CLARION IMPLANT COCHLEAR IMPLANT MCM ADVANCED BIONICS, LLC AB-5100L NA

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR