BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II EZ STEROX

    MDR report key: 22699831 · Received August 4, 2025

    Report

    Report Number
    2124215-2025-53799
    Event Type
    Injury
    Date Received
    August 4, 2025
    Date of Event
    July 22, 2025
    Report Date
    December 10, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    DTB
    UDI-DI
    00802526264993
    PMA / PMN Number
    P960004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS RIGHT ATRIAL (RA) LEAD WAS SUSPECTED TO BE FRACTURED, EXHIBITING HIGH OUT OF RANGE PACING IMPEDANCES ABOVE 3000 OMHS, NOISE OVERSENSING AND LOSS OF CAPTURE AT HIGH PACING THRESHOLDS. THE PHYSICIAN MENTIONED SCHEDULING A REPLACEMENT PROCEDURE FOR THIS LEAD. NO ADVERSE PATIENT EFFECTS WE REPORTED. THIS LEAD REMAINS IN SERVICE. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THIS LEAD WAS SURGICALLY ABANDONED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS RIGHT ATRIAL (RA) LEAD WAS SUSPECTED TO BE FRACTURED, EXHIBITING HIGH OUT OF RANGE PACING IMPEDANCES ABOVE 3000 OMHS, NOISE OVERSENSING AND LOSS OF CAPTURE AT HIGH PACING THRESHOLDS. THE PHYSICIAN MENTIONED SCHEDULING A REPLACEMENT PROCEDURE FOR THIS LEAD. NO ADVERSE PATIENT EFFECTS WE REPORTED. THIS LEAD REMAINS IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1353974 FINELINE II EZ STEROX IMPLANTABLE LEAD DTB BOSTON SCIENTIFIC CORPORATION 4470 00802526264993

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Female Required Intervention| H