BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATLAS PLUS VR

    MDR report key: 3210584 · Received July 8, 2013

    Report

    Report Number
    2938836-2013-03533
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Date of Event
    April 30, 2013
    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 PRESENTED IN CLINIC FOR A FOLLOW UP, SEVERAL VT/VF EPISODES WERE OBSERVED. THE VT/VF EPISODES WERE NON-SUSTAINED AND CONVERTED ON THEIR OWN. THE DATES DISPLAYED ON THE EPISODES WERE IN THE EXTREME PAST AND IN THE FUTURE. THE DIAGNOSTICS WERE CLEARED AND THE DEVICE WILL BE MONITORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310732 ATLAS PLUS VR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION V-193 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR