BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 2172918 · Received July 23, 2011

    Report

    Report Number
    2124215-2011-10977
    Event Type
    Injury
    Date Received
    July 23, 2011
    Date of Event
    May 26, 2011
    Report Date
    June 10, 2011
    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

    ALL AVAILABLE INFORMATION INDICATES THAT THE LEAD REMAINS INACTIVELY IMPLANTED. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT RIGHT ATRIAL (RA) PACING IMPEDANCE MEASUREMENTS WERE GREATER THAN 2,500 OHMS IN BIPOLAR AND UNIPOLAR CONFIGURATIONS. THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED NO CAPTURE IN BIPOLAR. AN INVASIVE REVISION PROCEDURE WAS PERFORMED AND THE RA WAS EXTRACTED AND THE RV LEAD WAS SURGICALLY ABANDONED. IT WAS THOUGHT THAT THE RA AND RV LEADS WERE BOTH FRACTURED. DURING THE PROCEDURE, THE DEVICE WAS EXPLANTED DUE TO NORMAL BATTERY DEPLETION. NO ADVERSE PATIENT EFFECTS WERE REPORTED DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FINELINE II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4474

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR 4473| 4474| 1298