BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 2780002 · Received October 10, 2012

    Report

    Report Number
    2124215-2012-12126
    Event Type
    Injury
    Date Received
    October 10, 2012
    Date of Event
    September 7, 2012
    Report Date
    November 29, 2012
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RETURN, THIS LEAD WAS THOROUGHLY ANALYZED. THE PRODUCT WAS CONFIRMED SEVERED, 9.2 CM FROM THE TERMINAL PIN WITH ONLY THE PROXIMAL SEGMENT RETURNED. SETSCREW MARKS WERE NOTED ON THE TERMINAL PIN AND RING. EXTENSIVE TESTING WAS PERFORMED TO ASSESS THE LEAD'S ELECTRICAL INTEGRITY. MEASUREMENTS THROUGHOUT THESE TESTS DEMONSTRATED CONTINUITY OF THE ELECTRICAL CIRCUITRY. LABORATORY ANALYSIS WAS UNABLE TO CONFIRM THE REPORTED CLINICAL OBSERVATIONS THROUGH RETURNED PRODUCT TESTING.

    Additional Manufacturer Narrative · 1

    THIS LEAD IS EXPECTED TO BE RETURNED TO BOSTON SCIENTIFIC. THIS REPORT WILL BE UPDATED WHEN THE LEAD HAS BEEN RETURNED AND ANALYSIS IS COMPLETE, OR IF ADDITIONAL INFORMATION ABOUT THIS ISSUE BECOMES AVAILABLE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT ATRIAL (RA) LEAD EXHIBITED HIGH OUT OF RANGE PACING IMPEDANCE. A SURGICAL PROCEDURE WAS PERFORMED AND THIS LEAD WAS EXPLANTED. A NEW LEAD WAS IMPLANTED SUCCESSFULLY. 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 4470

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention 1831| T167| 0148| 4470