BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 2172947 · Received July 23, 2011

    Report

    Report Number
    2124215-2011-10314
    Event Type
    Injury
    Date Received
    July 23, 2011
    Date of Event
    June 8, 2011
    Report Date
    October 11, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO
    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, IT WAS CONFIRMED THAT THERE WAS FRACTURE IN THE LEAD COILS. THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED AND THE COMPOSITION OF THE OUTER INSULATION, WIRE INSULATION, AND THE WIRE ARE CONSISTENT WITH A FINELINE LEAD MODE 4469. THE OUTER INSULATION SHOWED A KINK AT THE DISTAL END OF THE SUTURE SLEEVE AT THE LOCATION WHERE THE COIL FRACTURE WAS FOUND AT 186 MM FROM THE TERMINAL PIN. ADDITIONALLY, BOTH THE ANODE AND THE CATHODE SHOWED AN INCLUSION AT THE ORIGIN AND AREAS OF FATIGUE AND OVERLOAD. BOTH WIRES HAD A TITANIUM RICH INCLUSION AT THE ORIGIN WHICH IS LIKELY TITANIUM CARBO-NITRIDES FROM THE MP35N MANUFACTURING PROCESS. THUS, THE FAILURE MODE FOR BOTH FRACTURED WIRE WAS FATIGUE.

    Description of Event or Problem · 1

    --

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT ATRIAL LEAD EXHIBITED HIGH LEAD IMPEDANCE MEASUREMENTS OF GREATER THAN 3000 OHMS. THE LEAD WAS EXPLANTED AND SUCCESSFULLY REPLACED. THE DEVICE WAS EXPLANTED AT THE SAME TIME, TO AVOID AN ADDITIONAL SURGERY IN THE FUTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FINELINE II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4469

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention E110| T167| 0184| 4469