BEUDAMED
    FDA Adverse Event Death Summary report: N

    EASYTRAK 2

    MDR report key: 4226425 · Received November 5, 2014

    Report

    Report Number
    2124215-2014-19571
    Event Type
    Death
    Date Received
    November 5, 2014
    Date of Event
    September 9, 2014
    Report Date
    October 27, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NIK
    PMA / PMN Number
    P010012
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY
    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.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    SUBSEQUENTLY, BOSTON SCIENTIFIC RECEIVED INFORMATION FROM THE LOCAL REPRESENTATIVE THAT NO INVASIVE INTERVENTION HAD BEEN UNDERTAKEN. THE PATIENT HAD DEVELOPED (B)(6) AND HAD BEEN GIVEN IV ANTIBIOTICS FOR APPROXIMATELY ONE MONTH. AT SOME POINT IN TIME, THE PATIENT WAS PLACED ON COMFORT/PALLIATIVE CARE. THE PATIENT DIED OF COMPLICATIONS RELATED TO SEPSIS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS LOCAL REPRESENTATIVE CONTACTED BOSTON SCIENTIFIC'S TECHNICAL SERVICES (TS) ON SEPTEMBER 9, 2014. THE LOCAL REPRESENTATIVE WAS NOTIFIED THAT THIS PATIENT HAS AN INFECTED DEVICE AND LEAD SYSTEM. ASIDE FROM THE PATIENT'S ACTIVE LEADS, THE PATIENT HAS INACTIVE LEADS THAT HAD BEEN SURGICALLY CAPPED. THE LOCAL REPRESENTATIVE WAS INQUIRING ABOUT LEAD SPECIFICATIONS FOR A POSSIBLE INVASIVE INTERVENTION. THE ACTION PLAN FOR THIS PATIENT HAS NOT BEEN DETERMINED AS THE LOCAL REPRESENTATIVE WAS ENROUTE TO CONSULT WITH THE PHYSICIAN. THE DEVICE WAS CHECKED AND NO ANOMALIES WERE IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    711489 EASYTRAK 2 IMPLANTABLE LEAD NIK CPI - DEL CARIBE 4518

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Death| H| L 0041| 4470| 1786| 4266| 4518| 1520| 4269| N118| 1550| 1600| 0185| H175| 6017