BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FINELINE II EZ STEROX

    MDR report key: 18496370 · Received January 11, 2024

    Report

    Report Number
    2124215-2024-01290
    Event Type
    Malfunction
    Date Received
    January 11, 2024
    Date of Event
    December 18, 2023
    Report Date
    January 11, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    DTB
    UDI-DI
    00802526264993
    PMA / PMN Number
    P960004/S014
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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 ELECTROGRAM (EGM) REVIEW WAS REQUESTED FOR THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM DUE TO AN UPCOMING VENTRICULAR TACHYCARDIA (VT) ABLATION. UPON REVIEW, INTERMITTENT UNDERSENSING WAS OBSERVED ON THE RIGHT ATRIAL (RA) LEAD AND AUTOMATIC GAIN CONTROL (AGC) WAS SET TO 0.15MV. THE RA SIGNAL HAD SOME NOISE THAT WAS NOT OVERSENSED. P-WAVE MEASUREMENTS WERE 0.08-0.13MV, WHICH WAS UNDER THE PROGRAMMED FLOOR. IT WAS NOTED THAT THE PATIENT HAD A HISTORY OF ATRIAL FIBRILLATION (AF) ABLATION AND ATRIOVENTRICULAR JUNCTION (AVJ) ABLATION. TECHNICAL SERVICES (TS) REVIEWED TROUBLESHOOTING OPTIONS AND PROGRAMMING CONSIDERATIONS. THERE WAS A NOTICEABLE DROP IN SENSING AND IMPEDANCE MEASUREMENTS AROUND AUGUST 2023, AND TS DISCUSSED THAT THE PROCEDURES MAY HAVE IMPACTED RA SENSING. THIS CRT-D REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    646508 FINELINE II EZ STEROX PERMANENT PACEMAKER ELECTRODE DTB BOSTON SCIENTIFIC CORPORATION 4470 857087 00802526264993

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male