BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASYTRAK 3

    MDR report key: 1946182 · Received January 4, 2011

    Report

    Report Number
    2124215-2010-20432
    Event Type
    Injury
    Date Received
    January 4, 2011
    Date of Event
    October 20, 2010
    Report Date
    November 19, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PRODUCT IS CURRENTLY UNDERGOING DETAILED ANALYSIS. THIS EVENT WILL BE UPDATED UPON COMPLETION OF ANALYSIS.

    Additional Manufacturer Narrative · 1

    A REVISION PROCEDURE WAS PERFORMED, DURING WHICH THIS LV LEAD WAS EXPLANTED AND SUCCESSFULLY REPLACED WITH A NEW LV LEAD. A REQUEST HAS BEEN MADE TO HAVE THIS EXPLANTED LEAD RETURNED TO BOSTON SCIENTIFIC. THIS EVENT WILL BE UPDATED IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT IN OUR (B)(4) LABORATORY, A THOROUGH EVALUATION OF THE LEAD WAS PERFORMED. VISUAL INSPECTION NOTED DRIED BODILY FLUID IN THE LEAD LUMEN. THE CONDUCTOR COILS WERE DEFORMED AT 153, 295, 308 AND 486 MILLIMETERS (MM) FROM THE TERMINAL PIN; NOTED TO BE MOST LIKELY DUE TO A TYPE OF GRABBING TOOL AT EXPLANT. RESISTANCE AND PRESSURE TESTS WERE COMPLETED TO ASSESS THE ELECTRICAL PERFORMANCE AND INSULATION INTEGRITY OF THE LEAD. MEASUREMENTS THROUGHOUT THESE TESTS WERE WITHIN NORMAL LIMITS. MICROSCOPIC INSPECTIONS OF THE TERMINAL PIN ASSEMBLY, LEAD BODY, AND ELECTRODE TIP FOUND NO ANOMALIES. LABORATORY TESTING WAS UNABLE TO REPRODUCE THE REPORTED CLINICAL OBSERVATIONS AND DETAILED ANALYSIS DID NOT REVEAL ANY ABNORMALITIES.

    Description of Event or Problem · 1

    --

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS TRANSVENOUS LEFT VENTRICULAR (LV) LEAD DISLODGED SEVERAL DAYS AFTER IMPLANT. THE DISLODGEMENT WAS DISCOVERED WHEN AN X-RAY WAS TAKEN DURING A FOLLOW-UP DEVICE CHECK. SOME LV LOSS OF CAPTURE WAS REPORTEDLY OCCURRING AS A RESULT OF THE LV LEAD DISLODGEMENT.

    Description of Event or Problem · 1

    THE LEAD WAS LATER RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EASYTRAK 3 IMPLANTABLE LEAD OJX CPI - DEL CARIBE 4548

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Other| R 4548| 4136| 0180| 4555| N119