BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 2913258 · Received January 14, 2013

    Report

    Report Number
    2124215-2013-00542
    Event Type
    Injury
    Date Received
    January 14, 2013
    Date of Event
    December 17, 2012
    Report Date
    January 10, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE LEAD WAS PERFORMED. RESISTANCE AND PRESSURE TESTS WERE COMPLETED TO ASSESS LEAD ELECTRICAL PERFORMANCE AND INSULATION INTEGRITY. VISUAL INSPECTION SHOWED THE POLY INSULATION WAS FLATTENED AND TORN APART. ALL THE COILS AT THIS LOCATION WERE OBSERVED TO BE FRACTURED. THE DAMAGE LOCATION IS APPROXIMATELY 33.8 CENTIMETERS (CM) FROM TERMINAL PIN. THIS DAMAGE APPEARS TO BE INITIATED BY A LOCALIZED COMPRESSIVE STRESS ON SURFACE OF INSULATION. THE CLINICAL OBSERVATION WAS CONFIRMED BY ANALYSIS. DUE TO LOCATION AND TYPE OF DAMAGE IT WAS MOST LIKELY CAUSED BY ENTRAPMENT IN THE CLAVICLE/ FIRST-RIB REGION.

    Additional Manufacturer Narrative · 1

    THE LEAD WAS RETURNED. ANALYSIS OF THE RETURNED PRODUCT IS CURRENTLY ONGOING. THIS REPORT WILL BE UPDATED UPON COMPLETION.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT ATRIAL (RA) LEAD DISPLAYED A LOSS OF CAPTURE (LOC) WITH NOISE AND OVERSENSING ALONG WITH OUT OF RANGE PACING IMPEDANCE MEASUREMENTS OF LESS THAN 200 OHMS. FLUOROSCOPY WAS PERFORMED UPON WHICH TIME A LEAD FRACTURE WAS FOUND. THE LEAD WAS EXPLANTED AND REPLACED SUCCESSFULLY. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20717 FINELINE II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4470

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Life Threatening| R 4470| S606| 4471