BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MARATHON SR - EDGEBAND

    MDR report key: 1042103 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-34534
    Event Type
    Injury
    Date Received
    May 8, 2008
    Date of Event
    March 13, 2008
    Report Date
    March 14, 2008
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    DXY
    Removal / Correction Number
    Z1163/81-9
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MARATHON SR - EDGEBAND IMPLANTABLE PULSE GENERATOR DXY CARDIAC PACEMAKERS, INC 292-09E NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention THE DEVICE 4351/200833 WAS IMPLANTED| THE DEVICE 1394/108271 WAS IMPLANTED