BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6949 FIDELIS LEAD

    MDR report key: 1183017 · Received September 23, 2008

    Report

    Report Number
    1183017
    Event Type
    Malfunction
    Date Received
    September 23, 2008
    Date of Event
    May 27, 2008
    Report Date
    September 23, 2008
    Manufacturer
    MEDTRONIC INC. CARDIAC RHYTHM DISEASE MANAGEMENT
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THIS PT. HAD A MITRAL VALVE REPLACEMENT AND CORONARY BYPASS GRAFTING TIMES TWO APPROXIMATELY 3 OR 4 YEARS AGO. SUBSEQUENT TO THAT, SHE HAD A DEFIBRILLATOR PLACED BECAUSE OF A REDUCED EJECTION FRACTION. ON A MEDICAL REGIMEN, SHE HAD HAD IMPROVEMENT OF HER EJECTION FRACTION, WHICH NOW EXCEEDS GREATER THAN 40%. RECENTLY, SHE HAD TWO INAPPROPRIATE DISCHARGES FROM A FRACTURED RECALLED FIDELIS ICD ELECTRODE. THIS IS A RECALLED LEAD, AND THE DEVICE WAS INACTIVATED PRIOR TO HER PRESENTATION HERE. THE PATIENTADAMANTLY REQUESTED REMOVAL OF THE DEVICE IN ADDITION TO HER ICD ELECTRODE. THIS WAS DOCUMENTED AS REASONABLE BY THE MD WHO PERFORMED THE PROCEDURE AS WELL AS THE PATIENT'S CARDIAC ELECTROPHYSIOLOGIST. SHE WAS ADMITTED ON THIS OCCASION FOR LEAD EXTRACTION. PROCEDURE: 1. REMOVAL OF IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR GENERATOR 2. IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR LEAD EXTRACTION. 3. FLUOROSCOPY. 4. SUBPECTORAL IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR POCKET EXTIRPATION. OP NOTES INDICATE: "EXAMINATION OF THE LEAD SHOWED INSULATION BREAK BENEATH THEPROTECTIVE SHEATH USED FOR FIXATION TO THE CHEST WALL. THERE WAS ALSO POSSIBILITY OF A COIL BREAK JUST DISTAL TO THIS AREA."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 6949 FIDELIS LEAD LEAD, ICD LWS MEDTRONIC INC. CARDIAC RHYTHM DISEASE MANAGEMENT * *
    2 MAXIMO VR ICD LWS MEDTRONIC INC. CARDIAC RHYTHM MANAGEMENT MEDICAL PRODUCTS 7232CX *

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR