BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FINELINE II

    MDR report key: 1864181 · Received October 11, 2010

    Report

    Report Number
    2124215-2010-15982
    Event Type
    Malfunction
    Date Received
    October 11, 2010
    Date of Event
    June 14, 2010
    Report Date
    August 9, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    PMA / PMN Number
    P960004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CALLER STATED THAT THEY REPROGRAMMED THE VENTRCULAR PACING AND SENSING TO UNIPOLAR CONFIGURATION PERMANENTLY. R-WAVE MEASURMENTS WERE 3MV AND THERE WAS NOW EVIDENCE OF VENTRICULAR OVERSENSING. A BOSTON SCIENTIFIC TECHNICAL SERVICES CONSULTANT CONCURRED WITH THE PROGRAMMING CHANGES. 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 CRM RECEIVED INFORMATION THAT DURING A FOLLOW UP INTERROGATION, IT WAS REVEALED THE THE LEAD SAFETY SWITCH (LSS) HAD BEEN TRIGGERED ON THIS PATIENT'S PACEMAKER DUE TO AN IMPEDANCE MEASUREMENT GREATER THAN 2000 OHMS FROM THIS RIGHT VENTRICULAR LEAD. ALL OTHER LEAD MEASUREMENTS WERE WITHIN NORMAL LIMITS. IMPEDANCE MEASUREMENTS IN UNIPOLAR ARE CURRENTLY 490 OHMS AND 590 OHMS IN BIPOLAR CONFIGURATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FINELINE II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4459

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR 1270| S603| 4473| 4459