BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYMPHONY

    MDR report key: 828000 · Received March 13, 2007

    Report

    Report Number
    2182863-2007-00026
    Event Type
    Injury
    Date Received
    March 13, 2007
    Date of Event
    February 19, 2007
    Report Date
    March 13, 2007
    Manufacturer
    ELA MEDICAL S.A.S.
    Product Code
    DXY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MARCH, 13 2007. THE ANALYSIS FROM THE MANUFACTURER IS PENDING.

    Description of Event or Problem · 1

    AFTER 6 MONTHS OF IMPLANTATION AND PACEMAKER WAS EXPLANTED DO DIAPHRAGMATIC STIMULATION AND PAIN IN THE POCKET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYMPHONY CARDIAC PACEMAKER DXY ELA MEDICAL S.A.S. 2550 S060720

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Hospitalization