BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 2173001 · Received July 23, 2011

    Report

    Report Number
    2124215-2011-10641
    Event Type
    Injury
    Date Received
    July 23, 2011
    Date of Event
    June 9, 2011
    Report Date
    June 9, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    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 THIS RIGHT ATRIAL (RA) LEAD DISPLAYED HIGH PACING IMPEDANCE MEASUREMENTS GREATER THAN 2000 OHMS, SENSING WAS 2.9 MILLIVOLTS, AND LOSS OF CAPTURE AT MAXIMUM OUTPUTS. DURING A ROUTINE DEVICE CHANGE OUT PROCEDURE, THE LEAD WAS FOUND TO BE FRACTURED. THE LEAD WAS SURGICALLY ABANDONED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FINELINE II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4458

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR 4458| 1290| 4479| S606| 4135