BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FORTIFY DR

    MDR report key: 4091692 · Received January 13, 2014

    Report

    Report Number
    2938836-2014-04955
    Event Type
    Malfunction
    Date Received
    January 13, 2014
    Date of Event
    November 13, 2012
    Manufacturer
    ST. JUDE MEDICAL INC., CRMD
    Product Code
    LWS
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFO 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 CHARGE 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 A MERLIN TRANSMISSION REPORTED LEAD NOISE REVERSIONS, BUT THESE EPISODES WERE NOT STORED IN ELECTROGRAM. THE PT WAS NOT SET UP TO HAVE EPISODES AND THE PHYSICIAN DETERMINED THE DIAGNOSTICS TO BE CUMULATIVE. EPISODES WERE UNABLE TO BE REVIEWED AND AN INVALID MESSAGE WAS SEEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    33437 FORTIFY DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL INC., CRMD CD2333-40

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR