BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATLAS PLUS VR

    MDR report key: 3903638 · Received June 30, 2014

    Report

    Report Number
    2938836-2014-12821
    Event Type
    Injury
    Date Received
    June 30, 2014
    Date of Event
    May 10, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    LWS
    PMA / PMN Number
    P910023
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    PHYSICIAN

    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 A PATIENT PRESENTED IN THE EMERGENCY ROOM AFTER RECEIVING MULTIPLE INAPPROPRIATE HIGH VOLTAGE THERAPIES DUE TO A SOFTWARE RESET. THE RESET WAS BELIEVED TO BE DUE TO FOCUSED RADIATION TREATMENT FOR LUNG CANCER. A DEVICE DOWNLOAD WAS SUCCESSFULLY PERFORMED AND THE DEVICE REMAINS IMPLANTED. THE PATIENT NOW USES A MAGNET ON THE DEVICE WHEN RECEIVING RADIATION TREATMENT AND NO FURTHER ISSUES HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    380740 ATLAS PLUS VR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC., CRMD V-193 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention