BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATLAS II VR

    MDR report key: 1954723 · Received January 10, 2011

    Report

    Report Number
    2017865-2011-00549
    Event Type
    Injury
    Date Received
    January 10, 2011
    Date of Event
    November 7, 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 Location
    CA
    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 REPORTED THAT THE DEVICE WAS IN HARDWARE RESET (HWVVI) MODE. THE DEVICE WAS EXPLANTED AND REPLACED.

    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 55 YR Required Intervention