BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATLAS II PLUS HF CRT-D

    MDR report key: 3101293 · Received May 9, 2013

    Report

    Report Number
    2938836-2013-02091
    Event Type
    Injury
    Date Received
    May 9, 2013
    Date of Event
    January 20, 2012
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    NIK
    PMA / PMN Number
    P030054
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV
    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS EXPLANTED DUE TO HIGH LV THRESHOLD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203547 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 60 YR Required Intervention