BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASYTRAK 2

    MDR report key: 3050006 · Received April 10, 2013

    Report

    Report Number
    2124215-2013-03107
    Event Type
    Injury
    Date Received
    April 10, 2013
    Date of Event
    February 13, 2013
    Report Date
    April 12, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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 A THOROUGH PRODUCT ANALYSIS WAS PERFORMED. VISUAL INSPECTION CONFIRMED THE LEAD WAS BENT AND THE INNER INSULATION WAS TORN. ADDITIONALLY, THE CONDUCTOR COILS WERE FRACTURED APPROXIMATELY 297-299MM AND 318-322MM FROM THE TERMINAL PIN. THESE FRACTURES APPEARED TO BE LOCATED AT EITHER END OF THE SUTURE SLEEVE TIE DOWN SITE. AS A RESULT, THE CLINICAL OBSERVATION WAS CONFIRMED.

    Description of Event or Problem · 1

    --

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A ROUTINE FOLLOW-UP APPOINTMENT, IMPEDANCE MEASUREMENTS GREATER 2000 OHMS WERE NOTED ON THE LEFT VENTRICULAR (LV) LEAD WERE NOTED. ADDITIONALLY, THERE WAS NO CAPTURE. DURING THE LEAD REVISION, BLOOD INSIDE THE INSULATION WAS OBSERVED AND THE LEAD WAS FRACTURED UNDER THE SUTURE SLEEVE. THE LEAD COULD NOT BE EXPLANTED; THEREFORE, THE LEAD WAS SURGICALLY ABANDONED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    152867 EASYTRAK 2 IMPLANTABLE LEAD OJX CPI - DEL CARIBE 4543

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R