BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATLAS PLUS DR

    MDR report key: 1223488 · Received November 10, 2008

    Report

    Report Number
    2017865-2008-03623
    Event Type
    Injury
    Date Received
    November 10, 2008
    Date of Event
    July 28, 2008
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    PMAP910023
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED THE ANOMALY OBSERVED IN THE FIELD WAS NOT CONFIRMED IN THE LABORATORY. WHILE THE DEVICE WAS STORED AT 37 DEGREES CELSIUS, ITS TEMPERATURE WAS MEASURED DURING HIGH VOLTAGE CHARGING AND DELIVERING. THE DELTA TEMPERATURE WAS AROUND 3 DEGREES CELSIUS. THE DEVICE PERFORMED NORMALLY DURING BENCH TESTING. THE AUTOMATED TEST SYSTEM DETECTED NO ANOMALY AND THE DEVICE MET ALL SPECIFICCATIONS.

    Description of Event or Problem · 1

    PATIENT REQUESTED DEVICE CHANGE-OUT, DUE TO VERY HOT TO TOUCH. OUTPUT ANOMALY WAS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATLAS PLUS DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION V-243 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention