BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT FIDELIS

    MDR report key: 1131343 · Received August 6, 2008

    Report

    Report Number
    1131343
    Event Type
    Malfunction
    Date Received
    August 6, 2008
    Date of Event
    March 24, 2008
    Report Date
    August 6, 2008
    Manufacturer
    MEDTRONIC INC., CARDIAC RHYTHM MANAGEMENT
    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

    THE PATIENT HAD A PACEMAKER IMPLANTED IN THE REMOTE PAST. THIS WAS UPGRADED IN MARCH OF 2006 TO A DUAL-CHAMBER DEFIBRILLATOR. THE PATIENT HAD NOW PROGRESSED TO HAVING SEVERE CONGESTIVE HEART FAILURE, CLASS III, WITH A DOCUMENTED 25% EJECTION FRACTION. HE HAD SUSTAINED MONOMORPHIC VENTRICULAR TACHYCARDIA. HE WAS ADMITTED AT THIS TIME FOR UPGRADE TO A BIVENTRICULAR ICD AND EXTRACTION OF A RECALLED FIDELIS DEFIBRILLATOR ELECTRODE. UNDER FLUOROSCOPIC MONITORING, APPLYING GENTLE TRACTION, A STYLETTE WAS PASSED DOWN THE CHRONIC RIGHT ATRIAL LEAD, THE RECOILED FIDELIS LEAD AND THE ACTIVE FIXATION DEVICE WAS WITHDRAWN. UNDER CONSTANT TRACTION AND SOME ROTATIONAL TORSION, THE LEAD WAS REMOVED IN ITS ENTIRETY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPRINT FIDELIS LEAD, ICD LWS MEDTRONIC INC., CARDIAC RHYTHM MANAGEMENT 6949-65 *

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR