BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INOGEN? X4 CRT-D

    MDR report key: 23812317 · Received December 15, 2025

    Report

    Report Number
    2124215-2025-90986
    Event Type
    Malfunction
    Date Received
    December 15, 2025
    Date of Event
    November 25, 2025
    Report Date
    December 15, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NIK
    UDI-DI
    00802526534591
    PMA / PMN Number
    P010012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE HEALTH CARE PROFESSIONAL (HCP) WANTED TO REVIEW DATA ON THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D). TECHNICAL SERVICES (TS) REVIEWED THE DEVICE DATA AND DETERMINED THAT THESE STORED EVENTS WERE NOT ACTUALLY PACEMAKER MEDIATED TACHYCARDIA (PMT) AND SUSPECT5ED T O BE FARFIELD OVERSENSING. TS PROVIDED REPROGRAMMING RECOMMENDATIONS ON THE BLANKING PERIOD. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS CRT-D REMAINS IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    325098 INOGEN? X4 CRT-D CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) NIK BOSTON SCIENTIFIC CORPORATION G148 147039 00802526534591

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Female