BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 1862108 · Received October 8, 2010

    Report

    Report Number
    2124215-2010-15795
    Event Type
    Injury
    Date Received
    October 8, 2010
    Date of Event
    July 28, 2010
    Report Date
    July 28, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    AS OF THIS DATE, THE LEAD HAS NOT BEEN RETURNED. IF THIS LEAD SHOULD BE RETURNED TO OUR COMPANY, IT WILL BE ANALYZED AND THIS EVENT WILL BE REOPENED AND UPDATED AS NECESSARY.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT DURING THE IMPLANT PROCEDURE, THIS LEAD SHOWED AN OPEN CIRCUIT ON THE PACING SYSTEM ANALYZER, WHICH CAN INHIBIT PACING. SEVERAL CONFIGURATIONS WERE TRIED, AND NONE WERE SUCCESSFUL. THE LEAD WAS NOT USED AND ANOTHER LEAD WAS SUCCESSFULLY IMPLANTED IN IT'S PLACE. TO DATE, THERE HAVE BEEN NO ADVERSE PATIENT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FINELINE II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4470

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR 4592| 4470| N119| 0185