BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATLAS II PLUS HF CRT-D

    MDR report key: 3943866 · Received July 18, 2014

    Report

    Report Number
    2938836-2014-13489
    Event Type
    Malfunction
    Date Received
    July 18, 2014
    Date of Event
    June 19, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    NIK
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ASYMPTOMATIC PATIENT WAS PRESENTED IN CLINIC FOR FOLLOW-UP. POST-SENSED T-WAVE OVERSENSING WAS OBSERVED ON STORED EGM. THE DEVICE WAS REPROGRAMMED. THE PATIENT IS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    421486 ATLAS II PLUS HF CRT-D IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST. JUDE MEDICAL, INC., CRMD V-367 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR