BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EMBLEM MRI S-ICD

    MDR report key: 19481492 · Received June 7, 2024

    Report

    Report Number
    2124215-2024-34705
    Event Type
    Injury
    Date Received
    June 7, 2024
    Date of Event
    February 1, 2016
    Report Date
    June 6, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LWS
    PMA / PMN Number
    P110042/S058
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    OKAZAKI, MAKIKO, ET AL. (2023). INAPPROPRIATE SHOCK INCIDENCE IN PATIENTS WITH SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATORS WITH CONCOMITANT CARDIAC IMPLANTABLE ELECTRONIC DEVICES: A SINGLE CENTER COHORT STUDY. PACING CLIN ELECTROPHYSIOL. 2024;47:131 138. DOI: 10.1111/PACE.14887

    Description of Event or Problem · 0

    IT WAS REPORTED PER ARTICLE OF INTEREST LITERATURE REVIEW THAT THIS STUDY AIMED TO INVESTIGATE THE ASSOCIATION BETWEEN CONCOMITANT USE OF CARDIAC IMPLANTABLE ELECTRONIC DEVICES (CIEDS) AND INCIDENCE OF INAPPROPRIATE SHOCK IN PATIENTS WITH CURRENT-GENERATION SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (S-ICDS). THIS SINGLE-CENTER, RETROSPECTIVE, OBSERVATIONAL STUDY USED ELECTRONIC MEDICAL RECORDS AND LATITUDE NXT (BOSTON SCIENTIFIC, MARLBOROUGH, MA, USA) REMOTE MONITORING INFORMATION FROM SAKAKIBARA HEART INSTITUTE IN JAPAN. PATIENTS WERE IMPLANTED WITH EMBLEM (BOSTON SCIENTIFIC, MARLBOROUGH, MA, USA) A209 OR A219 MODELS. THE STUDY COHORT COMPRISED OF 127 CONSECUTIVE PATIENTS WHO UNDERWENT S-ICD IMPLANTATION AT OUR INSTITUTION BETWEEN FEBRUARY 2016 AND OCTOBER 2020. THE NUMBER OF EVENTS THAT OCCURRED WAS 17 IN THE NON-COMBINED GROUP AND FIVE IN THE COMBINED GROUP. ONE PATIENT IN THE NON-COMBINED GROUP WHO EXPERIENCED INAPPROPRIATE SHOCKS UNDERWENT S-ICD LEAD REPOSITIONING; THE OTHER PATIENTS DID NOT REQUIRE SURGICAL INTERVENTION. THE INAPPROPRIATE SHOCKS WERE MAINLY ADDRESSED THROUGH CHANGES IN THE THERAPY ZONE AND/OR VECTOR. THE MAJOR REASONS FOR INAPPROPRIATE SHOCK WERE MYOPOTENTIAL IN SIX EVENTS IN THE NON-COMBINED GROUP AND T-WAVE OVERSENSING IN TWO EVENTS IN THE COMBINED GROUP. REGARDING S-ICD PROGRAMMING DURING INAPPROPRIATE SHOCK EVENTS, SMART PASS WAS DISABLED IN FOUR PATIENTS IN THE NON-COMBINED GROUP AND TWO PATIENTS IN THE COMBINED GROUP. FURTHERMORE, 2XGAIN WAS SELECTED IN FOUR PATIENTS IN THE NON-COMBINED GROUP AND ONE PATIENT IN THE COMBINED GROUPS, RESPECTIVELY. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1580896 EMBLEM MRI S-ICD IMPLANTABLE DEVICE LWS BOSTON SCIENTIFIC CORPORATION A219

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Male Required Intervention| H