BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATLAS DR

    MDR report key: 1954715 · Received January 10, 2011

    Report

    Report Number
    2017865-2011-00569
    Event Type
    Malfunction
    Date Received
    January 10, 2011
    Date of Event
    October 13, 2010
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    P910023
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    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 THE PATIENT WAS IN HOSPICE CARE. THE DEVICE COULD NOT BE INTERROGATED IN ORDER TO TURN IT OFF. THE PATIENT WAS TERMINALLY ILL WITH CANCER AND EXPIRED A FEW DAYS LATER. THE DEVICE WAS NOT EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATLAS DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION V-242 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR