BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FINELINE II

    MDR report key: 2161220 · Received July 13, 2011

    Report

    Report Number
    2124215-2011-08436
    Event Type
    Malfunction
    Date Received
    July 13, 2011
    Date of Event
    April 14, 2011
    Report Date
    April 14, 2011
    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 LEAD WAS NOT RETURNED FOR TESTING. THEREFORE, BOSTON SCIENTIFIC CANNOT CONFIRM THE REPORTED CLINICAL OBSERVATIONS. 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 ATRIAL LEAD WAS EXHIBITING NOISE AND BIPOLAR IMPEDANCE MEASUREMENTS GREATER THAN 2500 OHMS. THE OUT OF RANGE IMPEDANCE MEASUREMENTS TRIGGERED THE LEAD SAFETY SWITCH (LSS) ON THE ASSOCIATED PACEMAKER. UNIPOLAR IMPEDANCE MEASUREMENTS WERE 500 OHMS AND THE LEAD WAS PROGRAMMED TO UNIPOLAR CONFIGURATION. ADDITIONALLY, NO SENSING MEASUREMENTS WERE OBSERVED FROM THIS LEAD WITH THE PACING SYSTEM ANALYZER (PSA). A REVISION PROCEDURE WAS PERFORMED AND THE LEAD WAS REMOVED FROM SERVICE AND REPLACED WITHOUT FURTHER INCIDENT. 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 4469

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR (B)(4)| (B)(4)| (B)(4)