BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FINELINE II

    MDR report key: 1771406 · Received July 27, 2010

    Report

    Report Number
    2124215-2010-12562
    Event Type
    Malfunction
    Date Received
    July 27, 2010
    Date of Event
    June 14, 2010
    Report Date
    June 14, 2010
    Manufacturer
    CPI - DEL CARIBE
    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 STATED THAT THEY WILL LEAVE THE LEAD IN UNIPOLAR CONFIGURATION AS THIS APPEARS TO BE THE SECOND TIME IT HAS HAPPENED. THE CALLER WILL DISCUSS THE ISSUE WITH THE PATIENT'S PHYSICIAN. 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 THIS ATRIAL LEAD HAD TRIGGERED THE LEAD SAFETY SWITCH (LSS) DUE TO OUT OF RANGE IMPEDANCE MEASUREMENTS. TODAY, ALL LEAD MEASUREMENTS ARE NORMAL IN BOTH CONFIGURATIONS AROUND 500 TO 600 OHMS. IN BIPOLAR CONFIGURATION, THERE WAS ONE MEASURING OF 1070 OHMS DURING POCKET MANIPULATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FINELINE II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4473

    Patients

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