BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATLAS II + DR

    MDR report key: 1010616 · Received March 10, 2008

    Report

    Report Number
    2017865-2008-01197
    Event Type
    Malfunction
    Date Received
    March 10, 2008
    Date of Event
    September 8, 2007
    Report Date
    October 30, 2007
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATLAS II + DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION V-268 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 * Hospitalization| L| R