BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 1945759 · Received January 4, 2011

    Report

    Report Number
    2124215-2010-20242
    Event Type
    Injury
    Date Received
    January 4, 2011
    Date of Event
    October 13, 2010
    Report Date
    January 7, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LEAD HAS BEEN RETURNED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON COMPLETION OF ANALYSIS.

    Additional Manufacturer Narrative · 1

    THE LEAD IS EXPECTED TO BE RETURNED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON RETURN AND COMPLETION OF ANALYSIS.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, THE LEAD WAS ANALYZED. VISUAL INSPECTION NOTED DRIED BODY FLUID IN THE LEAD LUMEN AND TISSUE IN THE HELIX. ELECTRICAL AND PRESSURE TESTS WERE PERFORMED. THE LEAD WAS ELECTRICALLY DISCONTINUOUS AND A HOLE IN THE INSULATION WAS NOTED APPROXIMATELY 30 CM FROM THE TERMINAL PIN. X-RAYS CONFIRMED THE LEAD CONDUCTOR HAD FRACTURED IN SEVERAL PLACES AT APPROXIMATELY 27 AND 30 CM FROM THE TERMINAL PIN. ANALYSIS NOTED INSULATION MARKS CONSISTENT WITH THE REPORTED FIGURE-EIGHT BEND IN THE LEAD. ANALYSIS CONCLUDED THE FRACTURE WAS LIKELY A RESULT OF THE FIGURE-EIGHT BEND AND FIRST RIB CLAVICULAR CRUSH.

    Description of Event or Problem · 1

    --

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT, DURING A ROUTINE FOLLOW-UP APPOINTMENT, IT WAS NOTED THIS LEAD HAD A PACING IMPEDANCE MEASUREMENT GREATER THAN 2500 OHMS. THE PATIENT WAS HOSPITALIZED. AN X-RAY WAS PERFORMED, AND A PORTION OF THE LEAD WAS SHAPED IN A FIGURE-EIGHT, WITH A CRACK NOTED ON ONE OF THE LOOPS. THE LEAD WAS EXPLANTED AND REPLACED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FINELINE II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4471

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention