BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESONATE X4 CRT-D

    MDR report key: 17340184 · Received July 18, 2023

    Report

    Report Number
    2124215-2023-37734
    Event Type
    Malfunction
    Date Received
    July 18, 2023
    Date of Event
    June 29, 2023
    Report Date
    December 14, 2023
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NIK
    UDI-DI
    00802526589539
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION. H6 CODE ADDED: A160102.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WITH THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS WITH ANESTHESIA ON THE OPERATION ROOM AND THE DEVICE WAS NOT ABLE TO BE INTERROGATED WITH A MAGNET. THE PHYSICIAN INDICATED THAT THE PATIENT IS LARGE. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) RECOMMENDED TO USE TWO MAGNETS AND A STETHOSCOPE. THIS CRT-D REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WITH THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS WITH ANESTHESIA ON THE OPERATION ROOM AND THE DEVICE WAS NOT ABLE TO BE INTERROGATED WITH A MAGNET. THE PHYSICIAN INDICATED THAT THE PATIENT IS LARGE. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) RECOMMENDED TO USE TWO MAGNETS AND A STETHOSCOPE. THIS CRT-D REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    169847 RESONATE X4 CRT-D CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) NIK BOSTON SCIENTIFIC CORPORATION G447 291367 00802526589539

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Male