BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIGILANT? X4 CRT-D

    MDR report key: 19482350 · Received June 7, 2024

    Report

    Report Number
    2124215-2024-34655
    Event Type
    Malfunction
    Date Received
    June 7, 2024
    Date of Event
    May 17, 2024
    Report Date
    May 1, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NIK
    UDI-DI
    00802526589287
    PMA / PMN Number
    P010012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 0

    THIS REPORT WAS AMENDED TO UPDATE INTERNATIONAL MEDICAL DEVICE REGULATORS FORUM (IMDRF) CODES. INCOMPLETE CODING OF THIS EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF COMPLAINTS ASSOCIATED WITH CAPA-8580, WHICH FOCUSED ON IDENTIFYING AND REMEDIATING INCOMPLETE CODING OF EVENTS. ADDED PATIENT CODE E060104. THE DEVICE REMAINS IMPLANTED AND IN SERVICE; THEREFORE, A TECHNICAL ANALYSIS COULD NOT BE PERFORMED. BASED ON A THOROUGH REVIEW OF THE REPORTED COMPLAINT, BOSTON SCIENTIFIC HAS ASSIGNED AN INVESTIGATION CONCLUSION CODE OF NO PROBLEM DETECTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT WITH THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXPERIENCED HEART RATE DROPPED INTO THE 30'S AT TIMES. HEALTH CARE PROFESSIONAL (HCP) STATED THAT THE DEVICE IS MALFUNCTIONING AND WANTED TO GET HOLD OF A LOCAL REPRESENTATIVE TO TURN DEVICE OFF. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED THAT IT WOULD BE IMPORTANT TO LET THE DEVICE CLINIC KNOW ABOUT HEART RATES BEING OBSERVED. ALSO, TS DID MENTION PHYSICIAN ORDER WOULD BE NEEDED FOR PROGRAMMING. TO DATE, THIS CRT-D REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT WITH THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXPERIENCED HEART RATE DROPPED INTO THE 30'S AT TIMES. HEALTH CARE PROFESSIONAL (HCP) STATED THAT THE DEVICE IS MALFUNCTIONING AND WANTED TO GET HOLD OF A LOCAL REPRESENTATIVE TO TURN DEVICE OFF. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED THAT IT WOULD BE IMPORTANT TO LET THE DEVICE CLINIC KNOW ABOUT HEART RATES BEING OBSERVED. ALSO, TS DID MENTION PHYSICIAN ORDER WOULD BE NEEDED FOR PROGRAMMING. TO DATE, THIS CRT-D REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    475356 VIGILANT? X4 CRT-D DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CRT-D NIK BOSTON SCIENTIFIC CORPORATION G247 307965 00802526589287

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male