BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 4150836 · Received October 8, 2014

    Report

    Report Number
    2124215-2014-17210
    Event Type
    Injury
    Date Received
    October 8, 2014
    Date of Event
    August 20, 2014
    Report Date
    August 22, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    DTB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    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 PATIENT WITH THIS RIGHT ATRIAL (RA) LEAD PRESENTED IN CLINIC WITH SHORTNESS OF BREATH AND UPON CHECK, OBSERVATIONS OF DECREASED SENSING AND IMPEDANCE MEASUREMENTS OF 200-400 OHMS WERE NOTED. SUBSEQUENTLY, NO CAPTURE WAS ALSO EXHIBITED BUT NO REPORT OF ASYSTOLE WAS DETECTED. THE DEVICE WAS THEN REPROGRAMMED AND AN X-RAY WAS DONE WHICH CONFIRMED THE LEAD WAS IN ITS POSITION; HENCE, PERFORATION WAS SUSPECTED. A LEAD REVISION WAS DONE WHERE IT WAS NOTED THAT THE LEAD HAD PERFORATED THROUGH THE LUNGS. A PERICARDIOCENTESIS WAS DONE AND ALMOST ONE LITER OF FLUID WAS DRAINED. THE LEAD REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    632744 FINELINE II IMPLANTABLE LEAD DTB CPI - DEL CARIBE 4470

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Hospitalization| L| O| R K173| 4470| 4136