BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 4140428 · Received October 3, 2014

    Report

    Report Number
    2124215-2014-17408
    Event Type
    Injury
    Date Received
    October 3, 2014
    Date of Event
    September 16, 2014
    Report Date
    October 14, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    DTB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT IS EXPECTED TO BE RETURNED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON RETURN AND COMPLETION OF ANALYSIS.

    Additional Manufacturer Narrative · 1

    (B)(4). UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, ONLY THE TERMINAL SEGMENT OF THE LEAD WAS RETURNED. VISUAL INSPECTION NOTED BRUISING OF THE SILICONE INSULATION, STRETCHED ANODE AND CATHODE COILS AND CATHODE FRACTURE APPROXIMATELY 25-26 CM FROM THE TERMINAL PIN. DETAILED ANALYSIS OF THE FRACTURE SITE DETERMINED THE CONDUCTOR COIL WAS FRACTURED DUE TO LOCALIZED COMPRESSIVE STRESS ON THE TUBING SURFACE. THE LOCATION OF THE DAMAGE SITE SUGGESTS THE FRACTURE WAS A RESULT OF CLAVICULAR CRUSH/FIRST RIB ENTRAPMENT. THE REPORTED LOC AND HIGH IMPEDANCE MEASUREMENTS ARE LIKELY THE RESULT OF THE LEAD DAMAGE OBSERVED BY THE LABORATORY.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED INDICATING THE PATIENT IS VERY ACTIVE PERFORMING HANDYMAN AND HOME RENOVATION ACTIVITIES WHICH ARE SUSPECTED TO HAVE CONTRIBUTED TO THE REPORTED LEAD DAMAGE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED LOSS OF CAPTURE (LOC) AND HIGH OUT-OF-RANGE PACE IMPEDANCE MEASUREMENTS UPON THE PATIENT'S PRESENTATION TO THEIR CLINIC FOR DISCOMFORT. THE PATIENT WAS NOTED TO BE ATRIAL FIBRILLATION (AF) WITH SLOW VENTRICULAR ESCAPE RHYTHM AT THE TIME OF THEIR PRESENTATION. AN X-RAY WAS OBTAINED INDICATING A LEAD CONDUCTOR FRACTURE NEAR THE CLAVICLE. THE PHYSICIAN ALSO SUSPECTED INSULATION DAMAGE AS THE PATIENT WAS REPORTED TO EXPERIENCE PECTORAL STIMULATION. A REVISION PROCEDURE WAS PERFORMED WHEREUPON THE LEAD SUSTAINED DAMAGE DURING THE EXTRACTION PROCESS RESULTING IN ITS SEVERING. THE LEAD WAS FULLY EXTRACTED AND REPLACED WITH A NEW RV LEAD. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS LEAD IS NO LONGER IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    618251 FINELINE II IMPLANTABLE LEAD DTB CPI - DEL CARIBE 4459

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R 4459| J276| 4473| 7742