BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSAR MAX II

    MDR report key: 1042291 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-34358
    Event Type
    Injury
    Date Received
    May 8, 2008
    Date of Event
    March 12, 2008
    Report Date
    March 12, 2008
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    DXY
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    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 PULSAR MAX II IMPLANTABLE PULSE GENERATOR DXY CARDIAC PACEMAKERS, INC 1180 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention THE DEVICE 4293/200978 WAS IMPLANTED 16-MAR-1998