BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FORTIFY ASSURA ST DR, DF-4 CONNECTOR

    MDR report key: 4173877 · Received October 15, 2014

    Report

    Report Number
    2938836-2014-16720
    Event Type
    Malfunction
    Date Received
    October 15, 2014
    Date of Event
    August 19, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    LWS
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. THE REPORTED SENSING ANOMALY WAS CONFIRMED IN THE LABORATORY AND WAS CAUSED BY PARYLENE MATERIAL THAT COATED THE RING CONTACT HELIX OF THE ATRIUM IS-1 LEAD BORE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, NO ATRIAL SENSING WAS OBSERVED WHEN THE ATRIAL LEAD WAS CONNECTED TO THE DEVICE. THE DEVICE WAS NOT IMPLANTED. NO FURTHER ISSUES WERE SEEN ON THE NEW DEVICE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    655680 FORTIFY ASSURA ST DR, DF-4 CONNECTOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC., CRMD CD2359-40QC NA

    Patients

    Seq Age Sex Outcome Treatment
    1