BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATLAS II VR

    MDR report key: 1954738 · Received January 10, 2011

    Report

    Report Number
    2017865-2011-00553
    Event Type
    Injury
    Date Received
    January 10, 2011
    Date of Event
    October 4, 2010
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    P910023
    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 THE REPORTED RESET WAS CONFIRMED IN THE LABORATORY. INTERROGATION FOUND THE DEVICE IN HARDWARE VVI (HWVVI) MODE AND THE MEMORY INDICATED THAT THE DEVICE EXPERIENCED A POWER ON RESET (POR). AFTER THE RESET WAS REMOVED, THE DEVICE'S FUNCTIONALITY WAS TESTED ON THE BENCH AND USING OUR AUTOMATED ELECTRICAL TESTING SYSTEM. TESTING REVEALED NORMAL DEVICE CHARACTERISTICS. IT IS SUSPECTED THAT THE RESET WAS DUE TO INTERFERENCE WITH ELECTRIC CAUTERY.

    Description of Event or Problem · 1

    THE PATIENT RECEIVED A VIBRATORY ALERT DUE TO HIGH VOLTAGE LEAD IMPEDANCE. T-WAVE OVERSENSING AND EXIT-BLOCK WERE OBSERVED. DURING THE LEAD REVISION, THE DEVICE WAS INTERROGATED AND THE WAS FOUND IN A BACK-UP VVI MODE WITHOUT HV THERAPY. THE DEVICE WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATLAS II VR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION V-168 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention (B)(4)