BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTISURE ACTIVE FIXATION, DF-4 CONNECTOR

    MDR report key: 21062106 · Received January 2, 2025

    Report

    Report Number
    2017865-2025-00072
    Event Type
    Malfunction
    Date Received
    January 2, 2025
    Date of Event
    December 16, 2024
    Report Date
    January 30, 2025
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
    Product Code
    NVY
    UDI-DI
    05414734507325
    PMA / PMN Number
    P950022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE CLINIC AFTER NOT BEING SEEN IN ABOUT 4 YEARS. IT WAS DISCOVERED THAT THE HIGH VOLTAGE LEAD IMPEDANCE AND PACE/SENSE IMPEDANCE WERE BOTH HIGH AND OUT OF RANGE. THERE WAS ALSO RIGHT VENTRICULAR (RV) LEAD NOISE CAUSING OVER-SENSING. IT IS EVIDENT THAT THE RV LEAD HAS A COMPLETE FRACTURE. THE DEVICE WAS TURNED OFF AND THE PATIENT WILL RECEIVE A LIFE VEST. A LEAD REVISION WILL BE PERFORMED IN THE NEAR FUTURE. THERE WERE NO ADVERSE HEALTH CONSEQUENCES, THE PATIENT WAS STABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE CLINIC AFTER NOT BEING SEEN IN ABOUT 4 YEARS. IT WAS DISCOVERED THAT THE HIGH VOLTAGE LEAD IMPEDANCE AND PACE/SENSE IMPEDANCE WERE BOTH OUT OF RANGE. THERE WAS ALSO RIGHT VENTRICULAR (RV) LEAD NOISE CAUSING OVER-SENSING. IT IS EVIDENT THAT THE RV LEAD HAS A COMPLETE FRACTURE. THE DEVICE WAS TURNED OFF AND THE PATIENT WILL RECEIVE A LIFE VEST. A LEAD REVISION WILL BE PERFORMED IN THE NEAR FUTURE. THERE WERE NO ADVERSE HEALTH CONSEQUENCES, THE PATIENT WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1641146 OPTISURE ACTIVE FIXATION, DF-4 CONNECTOR PERMANENT DEFIBRILLATOR ELECTRODES NVY ST. JUDE MEDICAL, INC.(CRM-SYLMAR) LDA210Q/58 A000035645 05414734507325

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Male FORTIFY ASSURA