BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIGILANT X4 CRT-D

    MDR report key: 11356251 · Received February 20, 2021

    Report

    Report Number
    2124215-2021-03659
    Event Type
    Injury
    Date Received
    February 20, 2021
    Date of Event
    January 26, 2021
    Report Date
    February 20, 2021
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NIK
    UDI-DI
    00802526589287
    PMA / PMN Number
    P010012/S436
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED FAST RIGHT VENTRICULAR (RV) LEAD PACING DURING AN ATRIAL FLUTTER ABLATION. IN ADDITION, IT WAS REPORTED THAT POST ABLATION PROCEDURE, THE SHOCK LEAD IMPEDANCE MEASUREMENTS ROSE TO 140-200 OHM RANGE. SUBSEQUENTLY, A 5 JOULE COMMANDED SHOCK WAS PERFORMED. THE SHOCK IMPEDANCE MEASUREMENT POST COMMANDED SHOCK WAS 70 OHMS, WITHIN RANGE FOR THIS LEAD. THE CRT-D SYSTEM REMAINS IN SERVICE AT THIS TIME. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252939 VIGILANT X4 CRT-D DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CRT-D NIK BOSTON SCIENTIFIC CORPORATION G247 195089 00802526589287

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| O