BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYTRAK 2

    MDR report key: 3955863 · Received July 24, 2014

    Report

    Report Number
    2124215-2014-14446
    Event Type
    Malfunction
    Date Received
    July 24, 2014
    Date of Event
    September 13, 2006
    Report Date
    June 30, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE LEFT VENTRICULAR LEAD CONFIGURATION WAS PROGRAMMED FROM TRUE BIOPOLAR TO EXTENDED BIPOLAR AND ACCEPTABLE IMPEDANCE MEASUREMENTS WERE OBSERVED. A BOSTON SCIENTIFIC TECHNICAL SERVICES REPRESENTATIVE DISCUSSED POTENTIAL REASONS FOR THE DIFFERENT IMPEDANCE MEASUREMENTS WITH DIFFERENT CONFIGURATIONS. THE PHYSICIAN HAS ELECTED TO MONITOR THE PATIENT. ADDITIONAL INFORMATION WAS RECEIVED OVER SIX YEARS AFTER THE OBSERVATION WAS REPORTED THAT THE OUT OF RANGE MEASUREMENTS WERE STILL OCCURRING. ALL OTHER LEAD DIAGNOSTICS REMAINS WITHIN NORMAL LIMITS. THIS PRODUCT ISSUE WILL BE UPDATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE IMPEDANCE MEASUREMENTS FOR THIS LEFT VENTRICULAR PACING LEAD HAVE INCREASED FROM 1269 OHMS AT IMPLANT TO GREATER THAN 2000 OHMS. SENSING AND CAPTURE REMAIN STABLE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    433765 EASYTRAK 2 IMPLANTABLE LEAD NIK CPI - DEL CARIBE 4518

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR 4518| 4470| 0185| H219