BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATLAS II PLUS HF CRT-D

    MDR report key: 3890563 · Received January 13, 2014

    Report

    Report Number
    2938836-2014-04448
    Event Type
    Malfunction
    Date Received
    January 13, 2014
    Date of Event
    September 16, 2011
    Manufacturer
    ST. JUDE MEDICAL INC., CRMD
    Product Code
    NIK
    PMA / PMN Number
    P030054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFO WAS PROVIDED BY MFR, NO MEDWATCH FORM WAS RECEIVED. THIS HISTORICAL COMPLAINT IS BEING FILED AS PART OF A RETROSPECTIVE REVIEW OF COMPLAINT FILES IN RESPONSE TO A RECENT FDA INSPECTION. THERE IS NO CHANGE TO THE ACTUAL PERFORMANCE OF THE PRODUCT AND THIS REPORT ONLY REPRESENTS AN ENHANCEMENT TO THE REPORTING CRITERIA GOING FORWARD. (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT PRESENTED DURING A FOLLOW UP WITH POST-PACED T WAVE OVERSENSING ON THE VENTRICULAR LEAD. REPROGRAMMING THE DEVICE WAS DISCUSSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30193 ATLAS II PLUS HF CRT-D IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST. JUDE MEDICAL INC., CRMD V-366

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR