BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASYTRAK 2

    MDR report key: 1871556 · Received October 15, 2010

    Report

    Report Number
    2124215-2010-17263
    Event Type
    Injury
    Date Received
    October 15, 2010
    Date of Event
    August 26, 2010
    Report Date
    September 17, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH LEAD ANALYSIS WAS PERFORMED. DRIED BLOOD/BODY FLUID WAS NOTED IN THE LEAD LUMEN. THE CONDUCTORS COILS WERE DEFORMED AT 132 AND 145 MM FROM THE TERMINAL PIN. THE CLINICAL OBSERVATIONS COULD NOT BE CONFIRMED THROUGH ANALYSIS.

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS BEEN RECEIVED AND IS CURRENTLY BEING ANALYZED. WHEN TESTING IS COMPLETE THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS LEFT VENTRICULAR LEAD DISLODGED. AS THE BRANCH WAS OCCLUDED, THE LEAD COULD NOT BE REPOSITIONED. AS A RESULT, THE LEAD WAS EXPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    --

    Description of Event or Problem · 1

    --

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention N119| 4592| 4543| 4470| 0185