BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASYTRAK 2

    MDR report key: 1873928 · Received October 19, 2010

    Report

    Report Number
    2124215-2010-17719
    Event Type
    Injury
    Date Received
    October 19, 2010
    Date of Event
    August 31, 2010
    Report Date
    October 29, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, IT WAS NOTED THAT THE COMPLETE LEAD WAS RETURNED WITH A SET SCREW MARK ON THE TERMINAL PIN AND RING AND THE INSULATION BENT AT 31.3 CM, 32.1 CM AND 34.6 CM FROM THE TERMINAL PIN. THE LEAD WAS TESTED AND FOUND TO BE DISCONTINUOUS ON BOTH ANODE AND CATHODE CONDUCTIVE PATHWAYS. ANALYSIS REVEALED BOTH ANODE AND CATHODE COILS FRACTURED THAT WERE LOCATED AT 32 CM FROM TERMINAL PIN. NO OTHER TESTS WERE PERFORMED DUE TO THE FRACTURE. DETAILED ANALYSIS SHOWED THAT THE OUTER INSULATION WAS KINKED AT THE FRACTURE SURFACE. EACH OF THE WIRE FRACTURES SHOWED EVIDENCE OF FATIGUE. THE ANODE WIRE ALSO SHOWED A FINAL TEAR RIDGE WHICH INDICATED SOME OVERLOAD. SOME CRACKING WAS OBSERVED IN THE SIDE OF THE CATHODE 2 WIRE.

    Additional Manufacturer Narrative · 1

    AT THIS TIME, THE LEAD HAS NOT BEEN RETURNED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE TO OUR COMPANY, THIS EVENT WOULD BE UPDATED.

    Additional Manufacturer Narrative · 1

    THIS LEAD HAS BEEN RETURNED AND IS CURRENTLY UNDERGOING ANALYSIS. THE EVENT WILL BE UPDATED ONCE ANALYSIS IS COMPLETE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS LEFT VENTRICULAR (LV) LEAD WAS EXPLANTED DUE TO A FRACTURE. A NEW LV LEAD WAS SUCCESSFULLY IMPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

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    Description of Event or Problem · 1

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    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EASYTRAK 2 IMPLANTABLE LEAD OJX CPI - DEL CARIBE 4518

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| L| R H219| 4518| 1852| 0184