BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 4232416 · Received November 6, 2014

    Report

    Report Number
    2124215-2014-19582
    Event Type
    Injury
    Date Received
    November 6, 2014
    Date of Event
    July 21, 2014
    Report Date
    July 21, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    DTB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, IT WAS NOTED THAT TWO SEGMENTS OF LEAD WERE RETURNED. THE TERMINAL SEGMENT MEASURED APPROXIMATELY 210 MM, AND THE MID-BODY SEGMENT MEASURED APPROXIMATELY 193 MM. THE MID-BODY SEGMENT HAD INSULATION WITH THE CONDUCTOR COILS EXTENDING OUT BOTH ENDS, ON ONE END THE CONDUCTOR COILS WERE EXTREMELY STRETCHED AND PULLED TO THE POINT OF BEING SEVERED. ANALYSIS DETERMINED THAT THIS DAMAGE WAS RELATED TO THE EXPLANT PROCEDURE. VISUAL INSPECTION OF THE RETURNED SEGMENTS FOUND MELTED POLYURTHANE INSULATION, WHICH WAS ATTRIBUTED TO LASER EXTRACTION OF THE LEAD OR ELECTROCAUTERY. CUTS IN THE INSULATION AND BLOOD AND BODY FLUID IN THE LUMEN WERE ALSO OBSERVED. ON THE RETURNED PORTIONS OF THE LEAD RESISTANCE AND PRESSURE TESTS WERE COMPLETED TO ASSESS LEAD ELECTRICAL PERFORMANCE. MEASUREMENTS THROUGHOUT THESE TESTS WERE WITHIN NORMAL LIMITS. ANALYSIS WAS NOT ABLE TO CONFIRM THE ALLEGATIONS FROM THE FIELD WITH THE RETURNED PORTIONS OF THE LEAD. IT WAS NOTED THAT THE TIP OF THE LEAD INCLUDING THE DISTAL ANODE RING WAS NOT RECEIVED FOR ANALYSIS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED AN INCREASE IN THRESHOLD MEASUREMENTS AND AN ACUTE RISE IN IMPEDANCE MEASUREMENTS FROM 400 OHMS TO 1400 OHMS. SUBSEQUENTLY A REVISION PROCEDURE WAS PERFORMED WHERE A PORTION OF THE LEAD WAS EXPLANTED. THE EXPLANTED PORTION WAS RETURNED FOR ANALYSIS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    714772 FINELINE II IMPLANTABLE LEAD DTB CPI - DEL CARIBE 4470

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Hospitalization| L| R 1297| K174| S606| 254-20| 438-01| 3830| 294-03| 4470| 294-09E| 480-01| 4469