BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 1853597 · Received October 5, 2010

    Report

    Report Number
    2124215-2010-14923
    Event Type
    Injury
    Date Received
    October 5, 2010
    Date of Event
    July 19, 2010
    Report Date
    September 8, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS LEAD WAS SURGICALLY ABANDONED; THEREFORE THE COMPANY WILL BE UNABLE TO PERFORM ANALYSIS ON THIS LEAD. SHOULD IT BE RETURNED, OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    THIS LEAD REMAINS IMPLANTED. AS A RESULT, BOSTON SCIENTIFIC CRM IS UNABLE TO CONFIRM THE CLINICAL OBSERVATIONS. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THIS EVENT WILL BE REOPENED IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS RIGHT ATRIAL LEAD EXHIBITED IMPEDANCE MEASUREMENTS GREATER THAN 2500 OHMS. AN X-RAY REVEALED NO LEAD FRACTURE.

    Description of Event or Problem · 1

    INFORMATION WAS LATER RECEIVED THAT THIS LEAD WAS SURGICALLY ABANDONED. 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 4472

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention