BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FIDELIS

    MDR report key: 3003751 · Received March 12, 2013

    Report

    Report Number
    3003751
    Event Type
    Malfunction
    Date Received
    March 12, 2013
    Date of Event
    February 11, 2013
    Report Date
    March 11, 2013
    Manufacturer
    MEDTRONIC
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    EXTRACTION OF FIDELIS LEAD AND A NEW RIGHT VENTRICULAR LEAD IMPLANTED, ALSO AN ICD GENERATOR CHANGE DUE TO ERI. THE PATIENT WAS RECENTLY SEEN IN OUR ICD CLINIC AT WHICH TIME THE PATIENT'S DEVICE WAS DISCOVERED TO BE AT ERI. HE HAS A CHRONIC SPRINT FIDELIS LEAD ON RECALL AND THE DECISION WAS MADE TO EXTRACT THIS LEAD AND REPLACE WITH A NEW LEAD. THE PATIENT WAS SEEN AND EXAMINED BY AN ELECTROPHYSIOLOGY STAFF PHYSICIAN AND DEEMED APPROPRIATE FOR A GENERATOR CHANGE.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?RIGHT VENTRICULAR LEAD EXTRACTION AND GENERATOR CHANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103423 FIDELIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) LWS MEDTRONIC 5076-65 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR