BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYMPHONY

    MDR report key: 1201756 · Received October 14, 2008

    Report

    Report Number
    2182863-2008-00053
    Event Type
    Injury
    Date Received
    October 14, 2008
    Date of Event
    August 30, 2008
    Report Date
    October 14, 2008
    Manufacturer
    ELA MEDICAL, S.A.S.
    Product Code
    DXY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A RESPONSE FROM THE MANUFACTURER IS PENDING.

    Description of Event or Problem · 1

    AFTER 1+ MONTHS OF IMPLANTATION, THIS PACEMAKER WAS EXPLANTED, BECAUSE OF AN INFECTION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R