BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FINELINE II

    MDR report key: 2040056 · Received April 5, 2011

    Report

    Report Number
    2124215-2011-00626
    Event Type
    Malfunction
    Date Received
    April 5, 2011
    Date of Event
    January 5, 2011
    Report Date
    January 5, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BOSTON SCIENTIFIC TECHNICAL SERVICES CONSULTANT DISCUSSED THE REPORTED CLINICAL OBSERVATIONS WITH THE CALLER. THE LEAD REMAINS IN SERVICE AND WILL BE MONITORED CLOSELY. NO OTHER ADVERSE EVENTS HAVE BEEN REPORTED. THIS ISSUE WILL BE RE-EVALUATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT'S PACEMAKER HAD PREVIOUSLY BEEN PROGRAMMED TO VVIR MODE DUE TO CHRONIC ATRIAL FIBRILLATION (AF). HOWEVER, THERE WAS NOISE THAT WAS REPRODUCIBLE AND WAS SHOWING UP AS STORED EPISODES. TODAY, THERE IS NO NOISE NOTED BUT THIS RIGHT VENTRICULAR LEAD HAD TRIGGERED THE LEAD SAFETY SWITCH (LSS) DUE TO OUT OF RANGE IMPEDANCE MEASUREMENTS. 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 4456

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR 1291| 4469| 4456