BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FORTIFY DR

    MDR report key: 3880601 · Received January 13, 2014

    Report

    Report Number
    2938836-2014-03412
    Event Type
    Malfunction
    Date Received
    January 13, 2014
    Date of Event
    December 13, 2012
    Manufacturer
    ST. JUDE MEDICAL INC., CRMD
    Product Code
    LWS
    PMA / PMN Number
    P910023
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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 GOING FORWARD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT PRESENTED TO THE CLINIC AFTER RECEIVING A PT NOTIFIER FOR HIGH OUT OF RANGE HIGH VOLTAGE LEAD IMPEDANCE. THE HIGH VOLTAGE LEAD WAS COMPETITIVE LEAD. THE IMPEDANCE TREND DISPLAYED A STABLE. IN RANGE IMPEDANCE TREND DISPLAYED A STABLE IN RANGE IMPEDANCE EXCEPT FOR OUTLYING OUT OF RANGE MEASUREMENTS FROM THE LAST FEW WEEKS. THE OVERALL PERFORMANCE OF THE DEVICE WAS GOOD. THE PT WAS PLANNED TO BE MONITORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    25949 FORTIFY DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR, LWS LWS ST. JUDE MEDICAL INC., CRMD CD2231-40

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR