BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASYTRAK 2

    MDR report key: 2910002 · Received January 11, 2013

    Report

    Report Number
    2124215-2012-15397
    Event Type
    Injury
    Date Received
    January 11, 2013
    Date of Event
    November 6, 2012
    Report Date
    December 3, 2012
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS EXPECTED TO BE RETURNED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON RETURN AND COMPLETION OF ANALYSIS.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, VISUAL INSPECTION OF THE LEAD CONFIRMED THAT THE CONDUCTOR COILS WERE FLATTENED AND FRACTURED APPROXIMATELY 36-38 CENTIMETERS (CM) FROM THE TERMINAL PIN. MICROSCOPIC EVALUATION INDICATED THAT THE INSULATION DAMAGE WAS CAUSED BY LOCALIZED COMPRESSIVE STRESS ON THE INSULATION SURFACE. DUE TO THE LOCATION AND THE TYPE OF DAMAGE EXHIBITED, IT WAS CONCLUDED THAT THE DAMAGE WAS CAUSED BY LEAD ENTRAPMENT IN THE CLAVICLE-FIRST RIB REGION.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A ROUTINE IN-CLINIC FOLLOW UP, THIS LEFT VENTRICULAR (LV) LEAD EXHIBITED HIGH OUT OF RANGE PACING IMPEDANCE MEASUREMENTS AND NO PACING. THE PATIENT EXPERIENCED SYMPTOMS; INCLUDING SHORTNESS OF BREATH. AN X-RAY WAS PERFORMED. THE LEAD WAS OBSERVED TO HAVE FRACTURED. AN INVASIVE PROCEDURE WAS PERFORMED TWO DAYS LATER. THE LEAD WAS SUCCESSFULLY EXPLANTED. IT WAS REPORTED THAT THE BRANCH COLLAPSED ON ITSELF UPON REMOVAL OF THE LEAD. AN ATTEMPT WAS MADE TO IMPLANT A NEW LV LEAD WITH NO SUCCESS. THE PROCEDURE WAS ABORTED AND ANOTHER PROCEDURE WILL LIKELY BE SCHEDULED FOR A DATE IN THE FUTURE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    17638 EASYTRAK 2 IMPLANTABLE LEAD OJX CPI - DEL CARIBE 4542

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| L| R 0185| 4136| 4542| E110| N119