BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATLAS II PLUS HF CRT-D

    MDR report key: 2984530 · Received February 28, 2013

    Report

    Report Number
    2938836-2013-00613
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Date of Event
    January 3, 2013
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    NIK
    PMA / PMN Number
    P030054
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    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 HAD COMPLETED SEVERAL ROUNDS OF RADIATION THERAPY, AND PRESENTED IN-HOSPITAL FOR DEVICE CHECK. THE DEVICE WAS FOUND TO BE IN BACKUP VVI MODE. THE DEVICE COULD NOT BE RESTORED DUE TO INTERMITTENT TELEMETRY. DEVICE TO BE EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    88299 ATLAS II PLUS HF CRT-D IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION V-366 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR