BEUDAMED
    FDA Adverse Event Death Summary report: N

    ATLAS PLUS VR

    MDR report key: 1073005 · Received July 11, 2008

    Report

    Report Number
    2017865-2008-02601
    Event Type
    Death
    Date Received
    July 11, 2008
    Date of Event
    April 23, 2008
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    PMA00001
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED: DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPIRED AFTER ONE THERAPY SHOCK WAS DELIVERED. A DEVICE MALFUNCTION WAS SUSPECTED. THE PHYSICIAN STATED, "I SUSPECT THAT IT HASN'T GIVEN SHOCK AND HAVE FAILED TO PACE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATLAS PLUS VR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION V-193 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death