BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATLAS PLUS VR

    MDR report key: 1954716 · Received January 10, 2011

    Report

    Report Number
    2017865-2011-00557
    Event Type
    Injury
    Date Received
    January 10, 2011
    Date of Event
    October 27, 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

    NO MEDWATCH FORM WAS RECEIVED. THE REPORTED FIELD EVENT OF RESET WAS VERIFIED IN THE LABORATORY. THE CAUSE OF THE RESET WAS DUE TO A POWER-ON- RESET (POR) THAT OCCURRED WHILE DELIVERING HIGH VOLTAGE THERAPY. IT IS BELIEVED THAT THE POR WAS DUE TO A LEAD ANOMALY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE ER AFTER FALLING UNCONSCIOUS. AT THE HOSPITAL THE DEVICE WAS FOUND IN BACKUP VVI MODE. IT WAS NOTED THAT THE HIGH VOLTAGE OUTPUT CIRCUITRY WAS DAMAGED DUE TO HIGH VOLTAGE SHOCK THERAPY. LEAD INSULATION DAMAGE SUSPECTED. THE DEVICE WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATLAS PLUS VR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION V-193 NA

    Patients

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