BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 1951627 · Received January 6, 2011

    Report

    Report Number
    2124215-2010-23853
    Event Type
    Injury
    Date Received
    January 6, 2011
    Date of Event
    November 24, 2010
    Report Date
    February 18, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SEVERED PROXIMAL SEGMENT OF THE LEAD WAS RETURNED TO OUR POST MARKET QUALITY ASSURANCE LABORATORY. VISUAL INSPECTION OF THE LEAD SEGMENT NOTED INSULATION DAMAGE AND STRETCHED CONDUCTOR COILS APPROXIMATELY 18 CM FROM THE TERMINAL PIN. BLOOD OR BODY FLUID WAS NOTED IN THE LEAD LUMEN. AN X-RAY OF THE LEAD CONFIRMED BOTH THE ANODE AND CATHODE CONDUCTOR WIRES HAD FRACTURED NEAR THE AREA OF INSULATION DAMAGE. BASED ON THE LOCATION OF THE FRACTURE AND THE INSULATION DAMAGE, LABORATORY ANALYSIS CONCLUDED THE REPORTED CLINICAL OBSERVATIONS LIKELY OCCURRED DUE TO CLAVICULAR-FIRST RIB ENTRAPMENT.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS LEAD HAD A PACING IMPEDANCE MEASUREMENT GREATER THAN 2,500 OHMS. THE LEAD WAS NOT SENSING, AND THEREFORE THE PATIENT WAS RECEIVING ASYNCHRONOUS PACING. A LEAD FRACTURE WAS SUSPECTED. THE PATIENT WAS HOSPITALIZED. A REVISION PROCEDURE WAS PERFORMED AND THE LEAD WAS EXPLANTED. 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 4459

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R