BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATLAS PLUS VR

    MDR report key: 2243084 · Received September 11, 2011

    Report

    Report Number
    2017865-2011-06619
    Event Type
    Injury
    Date Received
    September 11, 2011
    Date of Event
    July 8, 2011
    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 Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN.

    Additional Manufacturer Narrative · 1

    ANALYSIS CONFIRMED THE REPORTED DEVICE RESET. THE CAUSE OF THE RESET WAS UNKNOWN AS THE DEVICE WAS PROGRAMMED BEFORE BEING RETURNED AND NO DATA WAS OBTAINED FROM THE FIELD. THE DEVICE'S FUNCTIONALITY WAS TESTED ON THE AUTOMATED ELECTRICAL TEST SYSTEM AND NO ANOMALY WAS DETECTED. THE CAUSE OF THE RESET WAS NOT DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS IN RESET MODE. 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 84 YR Required Intervention