BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 1862083 · Received October 8, 2010

    Report

    Report Number
    2124215-2010-16410
    Event Type
    Injury
    Date Received
    October 8, 2010
    Date of Event
    July 19, 2010
    Report Date
    November 24, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    PMA / PMN Number
    P960004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME THE PRODUCT REMAINS IN SERVICE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS EVENT WILL BE UPDATED AS NECESSARY.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR (B)(4) LABORATORY VISUAL OBSERVATIONS CONFIRMED THAT ONLY THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED, TOTAL LENGTH = 641 MM. THE TIP WAS MISSING AND THE CONDUCTOR COILS WERE CUT. THERE WAS A CUT IN THE INSULATION AT 75, 150, 153, 266, 269, 361 AND 579 MM. THE EXTRACTING STYLET WAS RETURNED, STUCK IN LEAD. THE CONDUCTOR COILS WERE DEFORMED AT 71 MM FROM THE TERMINAL PIN AND STRETCHED FROM 477 - 641 MM FROM THE TERMINAL PIN. THE OUTER INSULATION ENDS AT 599 MM AND THERE WAS DRIED BODY FLUID THROUGH OUT THE LEAD LUMEN. THIS DAMAGE WAS DETERMINED TO BE PROCEDURALLY INDUCED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT SHORTLY AFTER THIS LEAD WAS IMPLANTED, NO P-WAVES COULD BE SEEN AND THE LEAD DISLODGED. A REVISION PROCEDURE WILL BE SCHEDULED SOON. TO DATE, THERE HAVE BEEN NO 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 4480

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention 1298| 4088| S603| 4470| 4480