BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLARION

    MDR report key: 1111743 · Received August 13, 2008

    Report

    Report Number
    3006556115-2008-00400
    Event Type
    Injury
    Date Received
    August 13, 2008
    Date of Event
    July 15, 2008
    Report Date
    July 15, 2008
    Manufacturer
    ADVANCED BIONICS LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Description of Event or Problem · 1

    THE PATIENT HAS A RECENT HEALTH CONDITION THAT REQUIRES AN MRI. SURGERY TO EXPLANT THE PT'S DEVICE HAS BEEN DISCUSSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLARION COCHLEAR IMPLANT MCM ADVANCED BIONICS LLC AB-5100H-11A NA

    Patients

    Seq Age Sex Outcome Treatment
    1