BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FIDELIS LEAD

    MDR report key: 1012988 · Received February 25, 2008

    Report

    Report Number
    1012988
    Event Type
    Malfunction
    Date Received
    February 25, 2008
    Date of Event
    February 13, 2008
    Report Date
    February 25, 2008
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THIS PATIENT, WITH A HISTORY OF HYPERTROPHIC CARDIOMYOPATHY, IS FOLLOWED BY A CARDIOLOGIST IN BOSTON. THREE YEARS AGO, HE HAD A DUAL-CHAMBER ICD IMPLANTED WITH FIDELIS LEAD. THIS FRACTURED, RESULTING IN MULTIPLE SHOCKS, WHICH WERE ONLY CONTROLLED BY REMOVAL OF THE DEVICE. THE LEAD WAS RETAINED AND ANOTHER FIDELIS LEAD IMPLANTED. THIS LEAD WAS SUBSEQUENTLY RECALLED. THE PATIENT WAS BROUGHT TO THE OPERATING ROOM WHERE STANDARD MONITORING AND GENERAL ANESTHESIA WERE SAFELY AND UNEVENTFULLY INDUCED.THE SURGEON FOUND A CAPPED, ABANDONED, AND RETAINED FIDELIS LEAD IMPLANTED ORIGINALLY THREE YEARS AGO, AND HE FOUND ANOTHER FIDELIS LEAD WITHIN THE HEADER OF THE DEVICE. THIS WAS IMPLANTED TWO YEARS LATER. BOTH OF THESE LEADS WERE FREED AND DISSECTED DOWN TO THEIR INSERTION SITES. THE OLDER OF THE TWO LEADS, WAS REMOVED IN ITS ENTIRETY WITHOUT DIFFICULTY. THE NEWER OF THE TWO LEADS, COULD NOT BE REMOVED IN THIS FASHION. ACCORDINGLY, THE LEAD WAS AMPUTATED AND A #1 LASER LOCKING STYLET WAS PASSED ON THE LENGTH OF THE LEAD. USING A LASER, THE SURGEON WAS ABLE TO REMOVE THIS LEAD IN ITS ENTIRETY WITHOUT DIFFICULTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FIDELIS LEAD LEAD, ICD LWS MEDTRONIC, INC. 6949 *
    2 SPRINT FIDELIS LEAD LEAD, ICD LWS MEDTRONIC, INC. 6949 *

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR