BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLARION IMPLANT

    MDR report key: 3902586 · Received May 9, 2014

    Report

    Report Number
    3006556115-2014-00215
    Event Type
    Malfunction
    Date Received
    May 9, 2014
    Date of Event
    April 20, 2014
    Report Date
    April 20, 2014
    Manufacturer
    ADVANCED BIONICS LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IR
    Reporter Occupation
    AUDIOLOGIST
    Health Professional
    N

    Narratives

    Description of Event or Problem · 1

    THE PATIENT REPORTEDLY EXPERIENCED INTERMITTENCIES FOLLOWED BY LOSS OF LOCK. EXTERNAL EQUIPMENT WAS EXCHANGED AND PROGRAMMING ADJUSTMENTS WERE MADE, HOWEVER, THE ISSUE WAS NOT RESOLVED. A DEVICE FAILURE WAS CONFIRMED. REVISION SURGERY WILL BE SCHEDULED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282357 CLARION IMPLANT COCHLEAR IMPLANT MCM ADVANCED BIONICS LLC AB-5100H NA

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Male