BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESONATE X4 CRT-D

    MDR report key: 16843515 · Received May 1, 2023

    Report

    Report Number
    2124215-2023-20744
    Event Type
    Malfunction
    Date Received
    May 1, 2023
    Date of Event
    March 3, 2023
    Report Date
    May 5, 2023
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NIK
    UDI-DI
    00802526589539
    PMA / PMN Number
    P010012/S436
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. CORRECTION TO H6: DEVICE CODE A070102/HIGH CAPTURE THRESHOLD WAS REMOVED.

    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 THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED FARFIELD OVERSENSING. IN ADDITION, THERE WAS AN ALERT TO CHECK THE RIGHT ATRIAL (RA) LEAD. REVIEW OF RA OUPUT REVEALED AUTO [email protected]; TECHNICAL SERVICES (TS) EXPLAINED THIS WAS LIKELY ATTRIBUTED TO FAILED RA AUTO THRESHOLD (RAAT) TESTS DUE TO THE OBSERVED FARFIELD OVESENSING. THIS CRT-D REMAINS IN SERVICE, AND DEVICE SENSITIVITY WAS ADJUSTED TO ADDRESS THE FARFIELD SIGNALS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED FARFIELD OVERSENSING. IN ADDITION, THERE WAS AN ALERT TO CHECK THE RIGHT ATRIAL (RA) LEAD. REVIEW OF RA OUPUT REVEALED AUTO [email protected]; TECHNICAL SERVICES (TS) EXPLAINED THIS WAS LIKELY ATTRIBUTED TO FAILED RA AUTO THRESHOLD (RAAT) TESTS DUE TO THE OBSERVED FARFIELD OVESENSING. THIS CRT-D REMAINS IN SERVICE, AND DEVICE SENSITIVITY WAS ADJUSTED TO ADDRESS THE FARFIELD SIGNALS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1362291 RESONATE X4 CRT-D DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CRT-D NIK BOSTON SCIENTIFIC CORPORATION G447 277815 00802526589539

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male