BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 1950403 · Received January 6, 2011

    Report

    Report Number
    2124215-2010-22408
    Event Type
    Injury
    Date Received
    January 6, 2011
    Date of Event
    November 12, 2010
    Report Date
    February 3, 2011
    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 REPORT WILL BE REOPENED AND UPDATED AS NECESSARY.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, VISUAL OBSERVATIONS CONFIRMED THAT THE COMPLETE LEAD WAS RETURNED. THERE WAS DRIED BODY FLUID THROUGH OUT THE ENTIRE LEAD LUMEN. THERE WAS A CUT IN THE INSULATION AT 245 ¿ 246 MM FROM THE TERMINAL PIN, AND THE INSULATION WAS BUNCHED 50 - 58 MM FROM THE TERMINAL PIN. THIS DAMAGE WAS DETERMINED TO BE PROCEDURALLY INDUCED.

    Additional Manufacturer Narrative · 1

    DETAILED ANALYSIS IS BEING PERFORMED ON THIS LEAD. UPON COMPLETION OF ANALYSIS, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR LEAD EXHIBITED HIGH THRESHOLDS. A LEAD REVISION PROCEDURE WAS DONE DURING WHICH TIME WHEN THE LEAD WAS PULLED THROUGH THE POCKET BY THE RING, THE PHYSICIAN NOTICES SOME STRETCHING AND SAW FLUID IN THE LEAD. THE DECISION WAS MADE TO EXPLANT THIS LEAD AND REPLACE IT WITH A NEW LEAD. TO DATE, THERE HAVE BEEN NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED.

    Description of Event or Problem · 1

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    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 83 YR Required Intervention 4470| S601