BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6949 SPRINT FEDELIS ICD LEAD

    MDR report key: 1010526 · Received February 5, 2008

    Report

    Report Number
    1010526
    Event Type
    Malfunction
    Date Received
    February 5, 2008
    Date of Event
    January 11, 2008
    Report Date
    February 5, 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

    MALE PT. UNDERWENT A REMOVAL OF IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR WITH LASER LEAD EXTRACTION OF AN EXISTING FRACTURED VVI LEAD A FEW YEARS AGO. THE PT. HAD HIS AICD IMPLANTED THIRTEEN YEARS AGO FOLLOWING A SYNCOPAL EPISODE AND DOCUMENTED SUSTAINED VENTRICULAR TACHYCARDIA. THE LEAD FRACTURE AT THAT TIME WAS DISCOVERED ON ROUTINE ANALYSIS IN FOLLOW UP. THE PT. RECEIVED A SHOCK, WHICH WAS INAPPROPRIATE. ON THIS OCCASION, ROUTINE FOLLOW UP AGAIN REVEALED LEAD FRACTURE, BUT NO INAPPROPRIATE SHOCKS WERE DELIVERED. THE PT. WAS BROUGHT TO THE OPERATING ROOM FOR LEAD REPLACEMENT BECAUSE OF RECALLED AND FAILING MEDTRONIC DEFIBRILLATOR LEAD. A STYLET WAS PASSED DOWN THE EXISTING RECALL LEAD AND THE ACTIVE FIXATION DEVICE. UNDER FLUOROSCOPIC GUIDANCE, USING GENTLE CONSTANT TRACTION AND SOME ROTATIONAL TORSION, WE WERE ABLE TO REMOVE THIS LEAD IN ITS ENTIRETY. UPON VISUAL EXAMINATION, THE LEAD SHOWED NO VISIBLE BREAKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 6949 SPRINT FEDELIS ICD LEAD LEAD, ICD LWS MEDTRONIC INC. CARDIAC RHYTHM MANAGEMENT DF-1SVC (18CM) DF-1B1

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR