BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FORTIFY ASSURA DR

    MDR report key: 3880613 · Received January 13, 2014

    Report

    Report Number
    2938836-2014-03404
    Event Type
    Malfunction
    Date Received
    January 13, 2014
    Date of Event
    November 20, 2012
    Manufacturer
    ST. JUDE MEDICAL, INC. CRMD
    Product Code
    LWS
    PMA / PMN Number
    P910023
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFO PROVIDED BY MANUFACTURER, 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 GOOD FORWARD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING FOLLOW UP THERE WAS POST PACED T WAVE OVERSENSING ON THE DEVICE. THE PT DID NOT RECEIVE THERAPY. TECH SERVICES DISCUSSED REPROGRAMMING THE POST PACED THRESHOLD AND POST PACED DECAY DELAY. AN INDUCTION TEST WAS RECOMMENDED. THE DEVICE REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26021 FORTIFY ASSURA DR IMPLANTALE CARDIOVERTER DEFIBRILLATOR, LWS LWS ST. JUDE MEDICAL, INC. CRMD CD2257-40

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR