BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRANSVENOUS

    MDR report key: 1874057 · Received October 19, 2010

    Report

    Report Number
    2124215-2010-19203
    Event Type
    Malfunction
    Date Received
    October 19, 2010
    Date of Event
    August 24, 2010
    Report Date
    September 2, 2010
    Manufacturer
    HISTORICAL CPI ST. PAUL
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    A BOSTON SCIENTIFIC CRM TECHNICAL SERVICES CONSULTANT DISCUSSED THE CLINICAL OBSERVATIONS WITH THE CALLER. THE CALLER EXPRESSED CONCERN REGARDING THE POSSIBILITY OF BLOOD IN THE HEADER OF THE ASSOCIATED PACEMAKER. THE PLAN IS TO REPROGRAM THE LEAD TO UNIPOLAR CONFIGURATION AND CONTINUE TO MONITOR THE PATIENT.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS PATIENT WAS RECENTLY IMPLANTED WITH A NEW IIS-1 HEADER DEVICE WHICH WAS INTERFACED TO THIS 3.2LP CHRONIC RIGHT VENTRICULAR LEAD. THE CALLER WAS INQUIRING ABOUT IF AN ISSUE WAS TO ARISE, HOW WOULD IT PRESENT ITSELF CLINICALLY. IMPEDANCE MEASUREMENTS WERE NOTED TO BE 100 OHMS WHICH HAD REMAINED UNCHANGED SINCE 1992. MOST RECENTLY, DEVICE EVALUATION NOTED THE LEAD SAFETY SWITCH (LSS) HAD BEEN TRIGGERED ON THE ASSOCIATED PACEMAKER DUE TO OUT OF RANGE IMPEDANCE MEASUREMENTS. IMPEDANCE WAS 1400 OHMS IN BIPOLAR CONFIGURATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRANSVENOUS IMPLANTABLE LEAD NVN HISTORICAL CPI ST. PAUL 4260

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR (B)(4)| (B)(4)| (B)(4)