BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FORTIFY DR

    MDR report key: 4081391 · Received January 14, 2014

    Report

    Report Number
    2938836-2014-06136
    Event Type
    Malfunction
    Date Received
    January 14, 2014
    Date of Event
    September 13, 2011
    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
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION 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 A PATIENT CAME INTO THE OFFICE DUE TO A PATIENT NOTIFIER FOR A HIGH RV LEAD IMPEDANCE. NO NOISE WAS SEEN WITH ISOMETRICS OR POCKET MANIPULATION. AT THIS POINT THE PATIENT WILL CONTINUE TO BE MONITORED. THE PATIENT NOTIFIER WAS TURNED BACK ON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    34806 FORTIFY DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR, LWS LWS ST. JUDE MEDICAL INC., CRMD CD2231-40

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR