BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASYTRAK 2

    MDR report key: 1853682 · Received October 5, 2010

    Report

    Report Number
    2124215-2010-15091
    Event Type
    Injury
    Date Received
    October 5, 2010
    Date of Event
    July 16, 2010
    Report Date
    August 17, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS OF TODAY, THE EXPLANTED PRODUCT HAS NOT BEEN RETURNED FOR ANALYSIS. IF THE PRODUCT IS RETURNED OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, VISUAL INSPECTION NOTED NO ANOMALIES. RESISTANCE AND PRESSURE TESTS WERE COMPLETED TO ASSESS THE LEAD'S ELECTRICAL PERFORMANCE AND INSULATION INTEGRITY. MEASUREMENTS THROUGHOUT THESE TESTS WERE WITHIN NORMAL LIMITS. A STYLET COULD NOT BE ADVANCED THROUGH THIS OPEN LUMEN LEAD DUE TO DRIED BODY FLUID WITHIN THE LUMEN. THE CLINICAL OBSERVATIONS OF LOSS OF CAPTURE AND DISLODGEMENT COULD NOT BE CONFIRMED DURING ANALYSIS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS LEFT VENTRICULAR LEAD WAS EXPLANTED DUE TO LOSS OF CAPTURE AND DISLODGEMENT. THE LEAD COULD NOT BE REPOSITIONED DUE TO AN OBSTRUCTED VENOUS ACCESS. AN EPICARDIAL LEAD IMPLANT WILL BE CONSIDERED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    THE LEAD WAS RETURNED FOR ANALYSIS.

    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 73 YR Hospitalization| R 0184| 4542| 4470| N119