BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 1951524 · Received January 6, 2011

    Report

    Report Number
    2124215-2010-23203
    Event Type
    Injury
    Date Received
    January 6, 2011
    Date of Event
    November 27, 2010
    Report Date
    November 27, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH THRESHOLD MEASUREMENTS AND INTERMITTENT LOSS OF CAPTURE, A DISLODGMENT IS SUSPECTED. IT WAS NOTED THAT THE PATIENT WAS SYMPTOMATIC DUE TO THE LOSS OF CAPTURE. THE RV LEAD WAS EXPLAINED AND A NEW LEAD WAS SUCCESSFULLY IMPLANTED. THE BOSTON SCIENTIFC SALES REPRESENTATIVE IS ATTEMPTING TO OBTAIN ADDITIONAL INFORMATION. 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 4456

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR Hospitalization| L| R S601| 4471| 4456