BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FORTIFY DR

    MDR report key: 4092177 · Received January 13, 2014

    Report

    Report Number
    2938836-2014-05017
    Event Type
    Malfunction
    Date Received
    January 13, 2014
    Date of Event
    August 23, 2011
    Manufacturer
    ST. JUDE MEDICAL INC., CARDIAC RHYTHM MANAGEMENT D
    Product Code
    LWS
    PMA / PMN Number
    P910023
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    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 THE PATIENT CAME TO THE CLINIC FOR THE FIRST POST-IMPLANT CHECK. THE PATIENT DISCUSSED THAT HE OCCASIONALLY FELT SOMETHING UNCOMFORTABLE. BRADY OBSERVED INTERMITTENT VENTRICULAR SAFETY PACING. SENSING, CAPTURE AND PACING LEAD IMPEDANCE ON BOTH WERE CONSISTENT AND ACCEPTABLE. CLINICALLY RESOLVED BY REPROGRAMMING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    22516 FORTIFY DR LWS ST. JUDE MEDICAL INC., CARDIAC RHYTHM MANAGEMENT D CD2231-40

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR