BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II EZ STEROX

    MDR report key: 3880798 · Received June 18, 2014

    Report

    Report Number
    2124215-2014-06328
    Event Type
    Injury
    Date Received
    June 18, 2014
    Date of Event
    March 11, 2014
    Report Date
    February 29, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    DTB
    UDI-DI
    00802526264993
    PMA / PMN Number
    P960004/S014
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    359348 FINELINE II EZ STEROX PERMANENT PACEMAKER ELECTRODE DTB BOSTON SCIENTIFIC CORPORATION 4470 00802526264993

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Male Required Intervention| H| L