BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 1953606 · Received January 10, 2011

    Report

    Report Number
    2124215-2010-24077
    Event Type
    Injury
    Date Received
    January 10, 2011
    Date of Event
    December 9, 2010
    Report Date
    December 9, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS RV LEAD WAS SINCE SUCCESSFULLY RE-POSITIONED THROUGH SURGICAL INTERVENTION. LOSS OF CAPTURE NO LONGER OCCURRED. THERE WERE NO ADVERSE PATIENT EFFECTS OTHER THAN THE ADDITIONAL PROCEDURE. THE INVESTIGATION IS NOW CONSIDERED CLOSED. IF NEW INFORMATION WERE TO BECOME AVAILABLE, THIS REPORT WILL BE FURTHER EVALUATED AND UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS TRANSVENOUS RIGHT VENTRICULAR (RV) LEAD DID EXHIBIT INTERMITTENT LOSS OF CAPTURE ONE DAY POST-IMPLANT. SENSING AND IMPEDANCE MEASUREMENTS WERE NOTED WITHIN NORMAL LIMITS. THE PHYSICIAN REPORTED NO ADVERSE PATIENT SYMPTOMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FINELINE II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4470

    Patients

    Seq Age Sex Outcome Treatment
    1