BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LINOX SMART SD 65/18 HIGH VOLTAGE TACHY LEAD

    MDR report key: 3657417 · Received February 28, 2014

    Report

    Report Number
    3657417
    Event Type
    Malfunction
    Date Received
    February 28, 2014
    Date of Event
    February 14, 2014
    Report Date
    February 28, 2014
    Manufacturer
    BIOTRONIK, INC.
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NV, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PATIENT HAS A BIOTRONIK DUAL-CHAMBER ICD WITH FAILURE DUE TO NOISE OF THE RV DEFIBRILLATOR LEAD WITH UPGRADE TO AN LV LEAD AND PLACEMENT OF A PACEMAKER LEAD IN THE RIGHT VENTRICLE AS WELL AS AN LV LEAD. THE PATIENT'S LV LEAD STOPPED WORKING. AT THIS POINT, DUE TO THE FACT THAT THE PATIENT HAD THREE LEADS THAT WERE NOT WORKING, WE WERE ASKED TO EXPLANT THE SYSTEM AND RE-IMPLANT. THE DECISION TO CHANGE THE SYSTEM FROM BIOTRONIK TO ST. JUDE WAS DUE TO THE FACT THAT THERE WAS NO CAPTURE IN THE LV LEAD WITH A BIOTRONIK LEAD AND SO THE ST. JUDE LEAD CAN PROVIDE NINE POLES/ELECTRODES FOR PACING WITH INCREASED CHANCES OF SUCCESSFUL BIV CAPTURE. THE CHRONIC LV LEAD IS A BIOTRONIK LINOX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124060 LINOX SMART SD 65/18 HIGH VOLTAGE TACHY LEAD DRUG-ELUTING PERMANENT DEFIBRILLATOR ELECTRODES NVY BIOTRONIK, INC. 65/18 *

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR CARDIAC DRUGS