BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 2905458 · Received January 9, 2013

    Report

    Report Number
    2124215-2012-13634
    Event Type
    Injury
    Date Received
    January 9, 2013
    Date of Event
    October 2, 2012
    Report Date
    November 26, 2012
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    PMA / PMN Number
    P960004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, VISUAL INSPECTION NOTED THE COMPLETE LEAD WAS RETURNED. THERE WAS DRIED BLOOD NOTED IN THE LEAD LUMEN FROM THE TERMINAL PIN DOWN TO THE MIDDLE SECTION TO THE DISTAL TIP. THERE WERE NO BREACHES OR CUTES NOTED IN THE INSULATION. ADDITIONALLY, ALL SEAL RINGS WERE IN GOOD CONDITION WITH NO SIGNS OF DAMAGE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PRODUCT WAS PART OF A SYSTEM REVISION DUE TO INFECTION. DURING THE EXPLANT PROCEDURE, THE PHYSICIAN NOTICED THERE WAS BLOOD IN THE LUMEN OF THIS RIGHT ATRIAL (RA) LEAD. THE RA LEAD WAS SUCCESSFULLY REMOVED AND WILL BE RETURNED FOR ANALYSIS. THERE WERE NO ADDITIONAL ADVERSE EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    11861 FINELINE II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4479

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| L| R K063| 4479| 4456