BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASYTRAK

    MDR report key: 1871175 · Received October 15, 2010

    Report

    Report Number
    2124215-2010-17977
    Event Type
    Injury
    Date Received
    October 15, 2010
    Date of Event
    August 24, 2010
    Report Date
    January 14, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LEAD HAS NOT BEEN RETURNED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS EVENT WOULD BE UPDATED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, THE COMPLETE LEAD WAS RETURNED. DRIED BLOOD AND BODY FLUID WAS NOTED TO HAVE INFILTRATED THE LEAD LUMEN. INSULATION SEPARATED IN MULTIPLE LOCATIONS ON THE LEAD. THE LEAD WAS THEN SUBJECT TO RESISTANCE TESTING TO VERIFY ELECTRICAL PERFORMANCE. MEASUREMENTS THROUGHOUT THESE TESTS WERE WITHIN NORMAL LIMITS. LABORATORY TESTING WAS UNABLE TO CONFIRM THE CLINICAL OBSERVATIONS, HOWEVER CONFIRMED THE LEAD'S ELECTRICAL PERFORMANCE WAS IN SPECIFICATION.

    Additional Manufacturer Narrative · 1

    THE LEAD IS CURRENTLY IN ANALYSIS. WHEN ANALYSIS IS COMPLETE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS LEFT VENTRICULAR LEAD DISLODGED. THE LEAD WAS EXPLANTED AND REPLACED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    FIVE MONTHS LATER THE LEAD WAS RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EASYTRAK IMPLANTABLE LEAD OJX CPI - DEL CARIBE 4513

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention N119| 4542| 4513| 4469| H135| H219| 0157