BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATLAS VR

    MDR report key: 1073070 · Received July 11, 2008

    Report

    Report Number
    2017865-2008-02316
    Event Type
    Injury
    Date Received
    July 11, 2008
    Date of Event
    April 21, 2008
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    PMA00001
    Removal / Correction Number
    Z1506
    Adverse Event
    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 THE FIELD EXPERIENCE OF HARDWARE RESET WAS VERIFIED IN THE LABORATORY. THE RESET WAS A POWER-ON RESET. WHEN THE DEVICE'S BATTERY VOLTAGE WAS MEASURED IN THE LAB, IT WAS FOUND TO BE UNEXPECTEDLY LOW. THE ROOT CAUSE OF THE FAILURE IS DUE TO A LATCH-UP OF THE STATIC RANDOM ACCESS MEMORY CHIP, WHICH IS CAUSED BY EXPOSURE TO IONIZING RADIATION. THE LATCH-UP CONDITION RESULTED IN HIGH CURRENT DRAW, WHICH DEPLETED THE BATTERY RESET.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT COMPLAINED OF A PAIN. WHEN THE DEVICE WAS INTERROGATED, IT WAS FOUND TO BE IN HARDWARE RESET. THE DEVICE WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATLAS VR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION V-199 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention