BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLARION

    MDR report key: 1191891 · Received October 1, 2008

    Report

    Report Number
    3006556115-2008-00494
    Event Type
    Malfunction
    Date Received
    October 1, 2008
    Date of Event
    September 5, 2008
    Report Date
    September 5, 2008
    Manufacturer
    ADVANCED BIONICS LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE PT REPORTEDLY EXPERIENCED LOSS OF LOCK. SURGERY TO EXPLANT THE PT'S DEVICE HAS BEEN SCHEDULED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR