BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FORTIFY ASSURA DR, DF-4 CONNECTOR

    MDR report key: 4240693 · Received November 10, 2014

    Report

    Report Number
    2938836-2014-17741
    Event Type
    Malfunction
    Date Received
    November 10, 2014
    Date of Event
    October 6, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    LWS
    PMA / PMN Number
    P910023
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN AN ASYMPTOMATIC PATIENT PRESENTED IN CLINIC FOR FOLLOW UP, THE DEVICE WAS POST-PACED T-WAVE OVERSENSING ON THE VENTRICULAR CHANNEL. PROGRAMMING CHANGES WERE MADE AND REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    724099 FORTIFY ASSURA DR, DF-4 CONNECTOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC., CRMD CD2257-40Q NA

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR