BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYTRAK 2

    MDR report key: 4132344 · Received October 1, 2014

    Report

    Report Number
    2124215-2014-17605
    Event Type
    Malfunction
    Date Received
    October 1, 2014
    Date of Event
    July 16, 2014
    Report Date
    July 16, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE LEAD WAS PERFORMED. VISUAL INSPECTION NOTED DRIED BLOOD OR BODY FLUID THROUGH THE LEAD LUMEN. THE LEAD INSULATION WAS CUT 315 TO 320 MILLIMETERS (MM) FROM THE TERMINAL PIN. ELECTRO-CAUTERY DAMAGE WAS EVIDENCED BY MELTED INSULATION AT 163 MM FROM THE TERMINAL PIN. THE LEAD PASSED THE CONTINUITY TEST WITH MANIPULATION. THE REPORTED LEAD DAMAGE WAS CONFIRMED. THE ALLEGATION OF HIGH IMPEDANCE MEASUREMENT, HOWEVER, COULD NOT BE CONFIRMED THROUGH ANALYSIS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS LEFT VENTRICULAR (LV) LEAD WAS DAMAGED DURING THE REVISION OF THE RIGHT ATRIAL (RA) LEAD AND EXHIBITED HIGH PACING LEAD IMPEDANCE MEASUREMENTS GREATER THAN 2,000 OHMS. THE LV LEAD WAS EXPLANTED AND WAS SUCCESSFULLY REPLACED. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE PHYSICIAN HAD ACCIDENTALLY CUT THE LEAD DURING THE RA LEAD REVISION. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612948 EASYTRAK 2 IMPLANTABLE LEAD NIK CPI - DEL CARIBE 4542

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR N160| 4135| 0295| 4542| 4554