BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II EZ STEROX

    MDR report key: 18263841 · Received December 4, 2023

    Report

    Report Number
    2124215-2023-68585
    Event Type
    Injury
    Date Received
    December 4, 2023
    Date of Event
    November 7, 2023
    Report Date
    August 17, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    DTB
    UDI-DI
    00802526265143
    PMA / PMN Number
    P960004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    **UDI RELATED DATA QUALITY UPDATES ONLY** THIS REPORT IS BEING FILED AS A CORRECTION IN RESPONSE TO AN FDA REQUEST FOR THE COMPLETE THE UNIQUE IDENTIFIER (UDI) #.

    Additional Manufacturer Narrative · 0

    IF PERTINENT INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A PACEMAKER TO CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) SYSTEM UPGRADE, THIS RIGHT ATRIAL (RA) LEAD EXHIBITED NOISE AND HIGH OUT-OF-RANGE PACE IMPEDANCE MEASUREMENTS GREATER THAN 3,000 OHMS WHEN CONNECTED TO THE CRT-P. NO OVERSENSING OR PACING INHIBITION WAS NOTED, AND RA LEAD FRACTURE WAS SUSPECTED. AS A RESULT, THE RIGHT ATRIAL (RA) LEAD WAS SURGICALLY ABANDONED AND REPLACED DURING THE SAME PROCEDURE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A PACEMAKER TO CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) SYSTEM UPGRADE, THIS RIGHT ATRIAL (RA) LEAD EXHIBITED NOISE AND HIGH OUT-OF-RANGE PACE IMPEDANCE MEASUREMENTS GREATER THAN 3,000 OHMS WHEN CONNECTED TO THE CRT-P. NO OVERSENSING OR PACING INHIBITION WAS NOTED, AND RA LEAD FRACTURE WAS SUSPECTED. AS A RESULT, THE RIGHT ATRIAL (RA) LEAD WAS SURGICALLY ABANDONED AND REPLACED DURING THE SAME PROCEDURE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2122753 FINELINE II EZ STEROX PERMANENT PACEMAKER ELECTRODE DTB BOSTON SCIENTIFIC CORPORATION 4469 538475 00802526265143

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Female Hospitalization| R