BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESONATE? X4 CRT-D

    MDR report key: 24414403 · Received February 23, 2026

    Report

    Report Number
    2124215-2026-09803
    Event Type
    Malfunction
    Date Received
    February 23, 2026
    Date of Event
    February 9, 2026
    Report Date
    February 23, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NIK
    UDI-DI
    00802526589539
    PMA / PMN Number
    P010012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED LOW BI-VENTRICULAR PACING PERCENTAGE ON THE LEFT VENTRICULAR (LV) CHANNEL. TECHNICAL SERVICES (TS) WAS CONSULTED AND UPON REVIEW DETERMINED THIS TO BE CAUSED BY P-WAVE OVERSENSING, WHICH LED TO PACING INHIBITION ON THE LV CHANNEL. TS RECOMMENDED ADJUSTMENTS FOR SENSITIVITY AND VECTOR POLARITY. AFTER REPROGRAMMING, THIS ISSUE WAS RESOLVED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS CRT-D REMAINS IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    158600 RESONATE? X4 CRT-D CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR NIK BOSTON SCIENTIFIC CORPORATION G447 355735 00802526589539

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Female