BEUDAMED
    FDA Adverse Event Other Summary report: N

    SPRINT FIDELIS

    MDR report key: 725214 · Received May 10, 2006

    Report

    Report Number
    725214
    Event Type
    Other
    Date Received
    May 10, 2006
    Date of Event
    April 24, 2006
    Report Date
    May 10, 2006
    Manufacturer
    MEDTRONIC, INC. CARDIAC RHYTHM MANAGEMENT
    Product Code
    LWS
    Report Source
    User Facility report
    Reporter Location
    MA, US

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS BROUGHT URGENTLY TO CATH LAB FOR VISUAL INSPECTION, LEAD TESTING, AND DEVICE REVISION. FOUND TO HAVE COMPLETE FRACTURE OF ICD LEAD. THIS IS POSSIBLY DUE TO EITHER INADVERTENT DAMAGE DURING IMPLANT PROCEDURE OR DEFECT IN MANUFACTURING. CHARGING OF ICD AFTER NEW LEAD PLACED ON RIGHT SIDE CAUSED ELECTRICAL SHORT WITH LOCAL HEAT PRODUCTION, WHICH CAUSED FIRST DEGREE BURN AND THE NEED TO REPLACE ICD. BOTH SUBCUTANEOUS LEADS WERE THEN REMOVED AND A TRANSVENOUS LEAD WAS IMPLANTED AND CONNECTED TO A NEW ICD. PATIENT EXPERIENCED FIRST DEGREE BURNS ASSOCIATED WITH HEAT IN SURGICAL POCKET. NO CLINICAL INTERVENTION NECESSARY. PATIENT DISCHARGED AND DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPRINT FIDELIS LEAD, ICD LWS MEDTRONIC, INC. CARDIAC RHYTHM MANAGEMENT LEAD 6931 *
    2 MEDTRONIC INTRINSIC 7288 ICD LWS MEDTRONIC INC. CARDIAC RHYTHM MANAGEMENT 7288 *
    3 CHRONIC SUB-Q LEAD, ICD LWS MEDTRONIC INC. CARDIAC RHYTHM MANAGEMENT 6996SQ *

    Patients

    Seq Age Sex Outcome Treatment
    1 *