BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYTRAK 2

    MDR report key: 1850088 · Received October 1, 2010

    Report

    Report Number
    2124215-2010-14973
    Event Type
    Malfunction
    Date Received
    October 1, 2010
    Date of Event
    June 22, 2010
    Report Date
    July 28, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LEAD HAS BEEN RETURNED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON COMPLETION OF ANALYSIS.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE LEAD WAS PERFORMED. RESISTANCE AND PRESSURE TESTS WERE COMPLETED TO ASSESS LEAD ELECTRICAL PERFORMANCE AND INSULATION INTEGRITY. MEASUREMENTS THROUGHOUT THESE TESTS WERE WITHIN NORMAL LIMITS. MICROSCOPIC INSPECTIONS OF THE TERMINAL PIN ASSEMBLY, LEAD BODY, AND ELECTRODE TIP WERE PERFORMED. THE CONDUCTOR COILS WERE STRETCHED AT A LOCATION APPROXIMATELY 70-80 CM FROM THE TERMINAL PIN. DRIED BLOOD OR BODY FLUID WAS NOTED THROUGHOUT THE LEAD LUMEN. DUE TO THE DRIED FLUID, A STYLET COULD NOT BE FULLY INSERTED INTO THE LEAD. LABORATORY TESTING WAS UNABLE TO REPRODUCE THE REPORTED CLINICAL OBSERVATIONS AND DETAILED ANALYSIS DID NOT REVEAL ANY ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO THE REPORTED HIGH THRESHOLDS AND OUT OF RANGE IMPEDANCE.

    Description of Event or Problem · 1

    --

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS LEAD HAD IMPEDANCE MEASUREMENTS GREATER THAN 2000 OHMS. THE LEAD ALSO HAD HIGH PACING THRESHOLD MEASUREMENTS. A FRACTURE WAS SUSPECTED. THE LEAD WAS EXPLANTED AND REPLACED. NO ADVERSE PATIENT EFFECTS WERE OBSERVED.

    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