BEUDAMED
    FDA Adverse Event Death Summary report: N

    ATLAS + DR

    MDR report key: 1050996 · Received May 27, 2008

    Report

    Report Number
    2017865-2008-01931
    Event Type
    Death
    Date Received
    May 27, 2008
    Date of Event
    April 10, 2008
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    PMA00001
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERAPY WAS DELIVERED, WHILE A MAGNET WAS PLACED OVER THE DEVICE. THE ER STAFF WERE TRYING TO RESCUE THE PATIENT WHEN HE CODED. THE MAGNET WAS HELD OVER THE DEVICE, WHILE THE STAFF ATTEMPTED TO REVIVE THE PATIENT USING COMPRESSIONS. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATLAS + DR NO BNCN FOUND FOR THIS DEVICE LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION V-243 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| R