BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO

    MDR report key: 3120059 · Received May 9, 2013

    Report

    Report Number
    3120059
    Event Type
    Injury
    Date Received
    May 9, 2013
    Date of Event
    April 29, 2013
    Report Date
    May 9, 2013
    Manufacturer
    MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA, US

    Narratives

    Description of Event or Problem · 1

    PATIENT HAD IMPLANTATION OF AICD LESS THAN 4 YEARS AGO FOR NONISCHEMIC CARDIOMYOPATHY, SEVERE LEFT VENTRICULAR SYSTOLIC DYSFUNCTION AND PERMANENT ATRIAL FIBRILLATION. THE LEAD WAS PLACED INTO THE RV APEX WHERE IT WAS NOTED TO BE PASSIVELY FIXED AND ELECTRONICALLY AND FLUOROSCOPICALLY STABLE. A DEVICE CHECK WAS DONE APPROXIMATELY 2 YEARS AFTER THE PROCEDURE SHOWED "RISING RV IMPEDANCE-6944 HIGH IMPEDANCE LEAD". PATIENT HAD ROUTINE CHECKS OF THE LEAD SHOWING GRADUAL INCREASES. HIS RV IMPEDANCE CONTINUED TO RISE AND WAS RECENTLY OVER 2000 OHMS. (THE PATIENT'S ICD DOES NOT ALLOW FOR LEAD MONITORING OVER 2000 OHMS AND DOES NOT HAVE AUTO THRESHOLDS WHICH MAKES MONITORING OF THE LEAD LIMITED BY R WAVE MEASUREMENTS ALONE) PATIENT RETURNED TO HAVE THE MALFUNCTIONING LEAD REMOVED AND REPLACED.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?AICD IMPLANTATION.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202592 SPRINT QUATTRO LEAD, ICD LWS MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT 6944 TDC083159V

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Hospitalization| L| R BOSTON SCIENTIFIC TELIGEN DEVICE, REFERENCE NUMBER| E102, SERIAL NUMBER (B)(4)