BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FINELINE II

    MDR report key: 3955870 · Received July 24, 2014

    Report

    Report Number
    2124215-2014-14415
    Event Type
    Malfunction
    Date Received
    July 24, 2014
    Date of Event
    May 2, 2014
    Report Date
    May 2, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    DTB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT RIGHT ATRIAL (RA) LEAD EXHIBITED NOISE BUT NOT OVERSENSED AND TRIGGERED LEAD SAFETY SWITCH (LSS) DUE TO LOW OUT OF RANGE IMPEDANCE MEASUREMENTS. DAILY MEASUREMENTS OVER THE YEAR HAVE BEEN 300-400 OHMS AND LOWEST AT 250 OHMS. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED POSSIBLE INSULATION ISSUE . ADDITIONAL INFORMATION OBTAINED FROM THE FIELD REPRESENTATIVE THAT THE CAUSE OF THESE OBSERVATIONS WAS NOT DETERMINED AND THE INSULATION ISSUE WAS NOT CONFIRMED. THE PHYSICIAN WILL CONTINUE TO MONITOR THE PATIENT. AT THIS TIME, THE RA LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    432972 FINELINE II IMPLANTABLE LEAD DTB CPI - DEL CARIBE 4472

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR 4458| 4472| 1297