BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASYTRAK 2

    MDR report key: 2151421 · Received July 6, 2011

    Report

    Report Number
    2124215-2011-07195
    Event Type
    Injury
    Date Received
    July 6, 2011
    Date of Event
    April 1, 2011
    Report Date
    April 1, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR (B)(6) LABORATORY, THE LEAD WAS THOROUGHLY INSPECTED AND ANALYZED. VISUAL INSPECTION NOTED THAT POLYURETHANE TUBING WAS PUCKERED, WITH ALL CONDUCTOR COILS AT THIS LOCATION TO BE FRACTURED, APPROXIMATELY 33 CM FROM THE PIN. THIS APPEARS TO BE THE LOCATION OF SUTURE SLEEVE TIE-DOWN. ANALYSIS REVEALED ALL CONDUCTOR COILS OF THE LEAD TO BE FRACTURED. EVIDENCES FOUND IN THE AREA OF THE FRACTURE SITE MAY SUGGEST DAMAGE POSSIBLY OCCURRED IN AREA OF SUTURE SLEEVE TIED-DOWN. THIS FINDING COULD HAVE CONTRIBUTED TO THE CLINICAL OBSERVATION. THE ELECTRICAL CONTINUITY TEST FAILED ON BOTH PATHWAYS. NO OTHER TESTS WERE PERFORMED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT LEFT VENTRICULAR (LV) IMPEDANCE MEASUREMENTS WERE OBSERVED TO BE GREATER THAN 2,000 OHMS. THE LV LEAD WAS UNABLE TO PACE UNDER 9 VOLTS AT 0.5 MS IN ANY PROGRAMMED VECTOR. AN INVASIVE REVISION PROCEDURE WAS PERFORMED AND THE LV LEAD WAS SUCCESSFULLY EXPLANTED AND REPLACED. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED WITH THIS CLINICAL OBSERVATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Hospitalization| R (B)(4)| (B)(4)| (B)(4)| (B)(4)| (B)(4)| (B)(4)| (B)(4)