BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTAIN OTW

    MDR report key: 1592340 · Received January 17, 2010

    Report

    Report Number
    1592340
    Event Type
    Malfunction
    Date Received
    January 17, 2010
    Date of Event
    December 10, 2009
    Report Date
    January 17, 2010
    Manufacturer
    MEDTRONIC INC., CARDIAC RHYTHM DISEASE MANAGEMENT
    Product Code
    OJX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PATIENT HAS A HISTORY OF NONISCHEMIC DILATED CARDIOMYOPATHY WITH SEVERELY DEPRESSED LEFT VENTRICULAR SYSTOLIC FUNCTION (MOST RECENT EF 25% TO 30% ON ECHOCARDIOGRAM ONE AND A HALF YEARS AGO), CHRONIC LEFT BUNDLE-BRANCH BLOCK WITH QRS DURATION OF 148 MILLISECONDS AND NEW YORK HEART ASSOCIATION CLASS III HEART FAILURE SYMPTOMS (HISTORICALLY). SHE UNDERWENT IMPLANTATION OF A MEDTRONIC DUAL-CHAMBER, BIVENTRICULAR ICD OVER THREE YEARS AGO. HER RIGHT VENTRICULAR (RV) AND LEFT VENTRICULAR (LV) LEAD THRESHOLDS WERE NOTED IN TIME TO BE SIGNIFICANTLY ELEVATED, REQUIRING HIGH-OUTPUT PACING. ADDITIONALLY, HER MEDTRONIC CONCERTO CRT-D REACHED PREMATURE ELECTIVE REPLACEMENT INTERVAL BUT DOES NOT APPEAR TO BE PART OF THE RECENT RECALL. HER RIGHT VENTRICULAR LEAD WAS SPRINT FIDELIS, MODEL 6949, AND WAS NOTED ON ROUTINE FOLLOW UP TO HAVE DECREASED SENSING, IN ADDITION TO ELEVATION IN THRESHOLDS. HER LV LEAD WAS IN THE ANTERIOR INTERVENTRICULAR BRANCH PACING THE ANTERIOR SEPTUM. SHE PRESENTED FOR LEAD REVISION AND NEW GENERATOR PLACEMENT. THERE WAS NO INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATTAIN OTW LEAD, LEFT VENTRICULAR OJX MEDTRONIC INC., CARDIAC RHYTHM DISEASE MANAGEMENT 4194-88 *
    2 SPRINT FIDELIS LEAD, DEFIBRILLATION LWS MEDTRONIC INC., CARDIAC RHYTHM DISEASE MANAGEMENT 6949 *
    3 CONCERTO DEFIBRILLATOR, CRT NIK MEDTRONIC INC. C154DWK *

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR