BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYTRAK 3

    MDR report key: 4140037 · Received October 3, 2014

    Report

    Report Number
    2124215-2014-17116
    Event Type
    Malfunction
    Date Received
    October 3, 2014
    Date of Event
    September 2, 2014
    Report Date
    September 2, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    LWP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DISPLAYED A MESSAGE INDICATING TO CHECK THE LEFT VENTRICULAR (LV) LEAD. THE LV PACING IMPEDANCE MEASUREMENTS RANGED BETWEEN 1,200 AND 2,000 OHMS IN THE LV TIP TO LV RING CONFIGURATION. AN LV PACING IMPEDANCE MEASUREMENT OF 386 OHMS WAS OBTAINED IN THE LV TIP TO RIGHT VENTRICULAR (RV) RING CONFIGURATION. A POTENTIAL LEAD FRACTURE IN THE PROXIMAL RING WAS SUSPECTED. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) PROVIDED TROUBLESHOOTING OPTIONS. THE LV SENSING CONFIGURATION WAS CHANGED AS WELL AND MONITORING WAS CONTINUED. THE SYSTEM REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    619668 EASYTRAK 3 IMPLANTABLE LEAD LWP CPI - DEL CARIBE 4548

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR H210| 0185| 4135| N141| 4548