BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 1951489 · Received January 6, 2011

    Report

    Report Number
    2124215-2010-22973
    Event Type
    Injury
    Date Received
    January 6, 2011
    Date of Event
    October 19, 2010
    Report Date
    November 24, 2010
    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

    SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS EVENT WILL BE UPDATED AND RESUBMITTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE RIGHT VENTRICULAR (RV) LEAD WAS DISLODGED. THEREFORE, THIS LEAD WAS EXTRACTED AND REPLACED WITH A COMPETITOR PRODUCT. THIS LEAD IS NOT INTENDED TO BE RETURNED TO BOSTON SCIENTIFIC FOR ANALYSIS. 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 75 YR Life Threatening| R 4456| 4479| S606