BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYTRAK 2

    MDR report key: 3904265 · Received July 1, 2014

    Report

    Report Number
    2124215-2014-08950
    Event Type
    Malfunction
    Date Received
    July 1, 2014
    Date of Event
    December 30, 2011
    Report Date
    April 10, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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 LEFT VENTRICULAR (LV) LEAD AND ASSOCIATED CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DISPLAYED PACING IMPEDANCES OF GREATER THAN 2000 OHMS. THE IMPEDANCE TREND WAS REVIEWED AND IT WAS NOTED THAT THE IMPEDANCE HAS BEEN FLUCTUATING OVER THE PAST YEAR. THE PATIENT WAS SEEN IN THE CLINIC. LV THRESHOLD MEASUREMENTS HAD INCREASED TO 4.0V @ 2.0MS, FROM 2.0V @ 1.0MS AT IMPLANT. THE PATIENT HAD ALSO BEEN EXPERIENCING DIAPHRAGMATIC STIMULATION. THE LEAD WAS REPROGRAMMED FROM LV TIP TO LV RING TO LV RING TO RV COIL, RESULTING IN PACING IMPEDANCE MEASUREMENTS WITHIN ACCEPTABLE LIMITS AND A THRESHOLD MEASUREMENT OF 3.0V @ 2.0MS. THE PHYSICIAN ELECTED TO CONTINUE MONITORING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    384106 EASYTRAK 2 IMPLANTABLE LEAD NIK CPI - DEL CARIBE 4518

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR 4518| N118| 0155| 1853| H179| 4480| 1861