BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESONATE X4 CRT-D

    MDR report key: 18494950 · Received January 11, 2024

    Report

    Report Number
    2124215-2024-01291
    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
    NIK
    UDI-DI
    00802526589539
    PMA / PMN Number
    P010012/S436
    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 (B)(6) 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
    667166 RESONATE X4 CRT-D DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CRT-D NIK BOSTON SCIENTIFIC CORPORATION G447 247147 00802526589539

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male