BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 2041830 · Received April 6, 2011

    Report

    Report Number
    2124215-2011-02219
    Event Type
    Injury
    Date Received
    April 6, 2011
    Date of Event
    January 14, 2011
    Report Date
    January 14, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT IN OUR POST MARKET QUALITY ASSURANCE LABORATORY, VISUAL OBSERVATIONS INDICATED A COMPLETE LEAD WAS RETURNED. IT WAS NOTED THAT THERE WHERE CUTS IN THE INSULATION AND THERE WAS DRIED BLOOD/BODY FLUID NOTED IN THE LEAD LUMEN. THE LEAD WAS THEN SUBJECTED TO A SERIES OF CATHODE, ANODE AND HIPOT MEASUREMENT TEST THAT WERE PERFORMED TO TEST THE LEAD FUNCTIONS. THE INITIAL ALLEGATIONS OF DISLODGEMENT COULD NOT BE CONFIRMED DURING TESTING.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT POST PROCEEDURE, BOTH LEADS WERE CONFIRMED TO HAVE DISLODGED OVERNIGHT. THE RIGHT ATRIAL AND VENTRICULAR (RV;RA) LEADS WERE EXPLANTED DUE TO DISLODGEMENT. A NEW RV AND RA LEAD WAS SUCCESSFULLY IMPLANTED. NO ADVERSE PATIENT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FINELINE II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4480

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention 4457| 4480| S603| 4137| 4136