BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 3921728 · Received July 9, 2014

    Report

    Report Number
    2124215-2014-13479
    Event Type
    Injury
    Date Received
    July 9, 2014
    Date of Event
    December 1, 2013
    Report Date
    May 20, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    DTB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    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 THE PACEMAKER WITH THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH OUT-OF-RANGE (OOR) PACING LEAD IMPEDANCE GREATER THAN 2,500 OHMS RESULTING IN ACTIVATION OF THE LEAD SAFETY SWITCH (LSS). A FIELD REPRESENTATIVE INDICATED THAT IMPEDANCE WAS HIGH FIVE MONTHS AGO AND HAS BEEN HIGH EVER SINCE. IN ADDITION, NOISE WAS OBSERVED IN EVENTS. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) SUGGESTED AN X-RAY TO ASSES LEAD. AN INVESTIGATION WAS PERFORMED AND INDICATED THAT THE CAUSE WAS UNDETERMINED AND WILL CONTINUE TO MONITOR PATIENT. HOWEVER, ADDITIONAL INFORMATION RECEIVED THAT THE RV LEAD WAS EXPLANTED. AN INSULATION ISSUE WAS BELIEVED TO THE CAUSE HOWEVER WAS NOT CONCLUSIVELY DETERMINED. THE RV LEAD WAS NO LONGER IN SERVICE. THE PACEMAKER REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    399454 FINELINE II IMPLANTABLE LEAD DTB CPI - DEL CARIBE 4470

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| L| R S603| 4470| 4469