BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLARION IMPLANT

    MDR report key: 3800590 · Received February 11, 2014

    Report

    Report Number
    3006556115-2014-00072
    Event Type
    Malfunction
    Date Received
    February 11, 2014
    Date of Event
    January 14, 2014
    Report Date
    January 14, 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 PT REPORTEDLY EXPERIENCED INTERMITTENCIES FOLLOWED BY LOSS OF LOCK. PROGRAMING ADJUSTMENTS WERE MADE AND EXTERNAL EQUIPMENT WAS EXCHANGED. HOWEVER THIS DID NOT RESOLVE THE ISSUE. REVISION SURGERY IS UNDER CONSIDERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    90034 CLARION IMPLANT COCHLEAR IMPLANT MCM ADVANCED BIONICS, LLC AB-5100H NA

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Female