BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASYTRAK 3

    MDR report key: 3213577 · Received July 9, 2013

    Report

    Report Number
    2124215-2013-08615
    Event Type
    Injury
    Date Received
    July 9, 2013
    Date of Event
    June 10, 2010
    Report Date
    April 11, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    PMA / PMN Number
    P010012
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    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 PATIENT ADVOCATE REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD HAD FRACTURED A FEW YEARS AGO. THE LV LEAD WAS NOT REPLACED BECAUSE THE PATIENT WAS TOO OLD AND HEART TISSUES GREW AROUND IT. A BOSTON SCIENTIFIC COMPANY REPRESENTATIVE ADVISED TO CONTACT THE PHYSICIAN FOR HEALTH AND LEAD CONCERNS. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION WERE UNSUCCESSFUL. THE LV LEAD REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313913 EASYTRAK 3 IMPLANTABLE LEAD OJX CPI - DEL CARIBE 4549

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Life Threatening 4262| 1298| 1148T| 2028L| N119| H177| 4513| 4549| 6949