BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSAR MAX DR

    MDR report key: 1041614 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-31920
    Event Type
    Injury
    Date Received
    May 8, 2008
    Date of Event
    March 9, 2006
    Report Date
    February 29, 2008
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    DXY
    Removal / Correction Number
    Z875/897-3
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSAR MAX DR IMPLANTABLE PULSE GENERATOR DXY CARDIAC PACEMAKERS, INC 1270 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention THE DEVICE 430-/67952M WAS IMPLANTED 30-AUG-1993| THE DEVICE 432-/54361R WAS IMPLANTED 30-AUG-1993