BEUDAMED
    FDA Adverse Event Death Summary report: N

    PULSAR MAX II

    MDR report key: 637896 · Received February 9, 2004

    Report

    Report Number
    2124215-2004-06825
    Event Type
    Death
    Date Received
    February 9, 2004
    Date of Event
    July 2, 2002
    Report Date
    December 9, 2003
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    DXY
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    EVENT DESCRIPTION GUIDANT RECEIVED INFORMATION THAT THE PATIENT WITH THIS IMPLANTABLE PACEMAKER (IPM) IS DECEASED. A FAMILY MEMBER COMPLAINS OF WRONGFUL DEATH CAUSED BY THE DOCTORS, STAFF AND OTHER PERSONNEL, AND BY EQUIPMENT FAILURE AND MALFUNCTION OF THE PACEMAKER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSAR MAX II IMPLANTABLE PULSE GENERATOR DXY CARDIAC PACEMAKERS, INC 1280 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Death