BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FORTIFY DR

    MDR report key: 4055032 · Received January 14, 2014

    Report

    Report Number
    2938836-2014-05931
    Event Type
    Malfunction
    Date Received
    January 14, 2014
    Date of Event
    March 16, 2012
    Manufacturer
    ST. JUDE MEDICAL, INC. CRMD
    Product Code
    LWS
    PMA / PMN Number
    P910023
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A RIGHT VENTRICULAR LEAD WITH INTERMITTENT OUT OF RANGE PACING LEAD IMPEDANCE. THE PATIENT WAS ALERTED BY THE PATIENT NOTIFIER AND WAS BROUGHT INTO CLINIC FOR FOLLOW UP. THE DEVICE REPORTED A HIGH OUT OF RANGE PACING LEAD IMPEDANCE IN THE WEEK TREND GRAPH. LEAD TESTING INVOLVING ISOMETRICS, ARM POSITIONING, AND POCKET MANIPULATIONS IN AN ATTEMPTS TO REPRODUCE ADDITIONAL OUT OF RANGE IMPEDANCES AND NOISE ON THE IEGS WERE DONE WITH NO NOISE REPRODUCED AND THE IMPEDANCES INCREASING. THE LEAD REMAINS IN THE FIELD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    37667 FORTIFY DR IMPLANTABLE CARDIOVERTER DIFIBRILLATOR LWS ST. JUDE MEDICAL, INC. CRMD CD2231-40

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR