BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESONATE X4 CRT-D

    MDR report key: 16499979 · Received March 7, 2023

    Report

    Report Number
    2124215-2023-10797
    Event Type
    Malfunction
    Date Received
    March 7, 2023
    Date of Event
    February 2, 2022
    Report Date
    April 14, 2023
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NIK
    PMA / PMN Number
    P010012/S436
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT OVER THE COURSE OF FIVE DAYS, THIS PATIENT RECEIVED THREE INAPPROPRIATE SHOCKS DUE TO DOUBLE-COUNTING OVER-SENSING. BOSTON SCIENTIFIC TECHNICAL SERVICES WAS CONTACTED FOR A DEVICE DATA REVIEW. IT WAS DISCUSSED THAT THE PATIENT'S RIGHT VENTRICULAR (RV) R-WAVE MEASUREMENTS WERE QUITE LOW, WHICH CONTRIBUTED TO THE DOUBLE-COUNTING. THE PHYSICIAN HAD STATED THAT THE PATIENT RECENTLY HAD AN ABLATION PROCEDURE, WHICH WAS STATED TO BE THE CAUSE OF THE LOW R-WAVE AMPLITUDE MEASUREMENTS. THE PHYSICIAN ELECTED TO ALTER THE PATIENT'S MEDICATION AND PROGRAMMED THERAPY SETTINGS TO RESOLVE THE EVENT. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS DEVICE REMAINS IMPLANTED AND IN-SERVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT OVER THE COURSE OF FIVE DAYS, THIS PATIENT RECEIVED THREE INAPPROPRIATE SHOCKS DUE TO DOUBLE-COUNTING OVER-SENSING. BOSTON SCIENTIFIC TECHNICAL SERVICES WAS CONTACTED FOR A DEVICE DATA REVIEW. IT WAS DISCUSSED THAT THE PATIENT'S RIGHT VENTRICULAR (RV) R-WAVE MEASUREMENTS WERE QUITE LOW, WHICH CONTRIBUTED TO THE DOUBLE-COUNTING. THE PHYSICIAN HAD STATED THAT THE PATIENT RECENTLY HAD AN ABLATION PROCEDURE, WHICH WAS STATED TO BE THE CAUSE OF THE LOW R-WAVE AMPLITUDE MEASUREMENTS. THE PHYSICIAN ELECTED TO ALTER THE PATIENT'S MEDICATION AND PROGRAMMED THERAPY SETTINGS TO RESOLVE THE EVENT. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS DEVICE REMAINS IMPLANTED AND IN-SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125596 RESONATE X4 CRT-D DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CRT-D NIK BOSTON SCIENTIFIC CORPORATION G447 278834

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown