BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EMBLEM MRI S-ICD

    MDR report key: 22046591 · Received May 19, 2025

    Report

    Report Number
    2124215-2025-32082
    Event Type
    Injury
    Date Received
    May 19, 2025
    Date of Event
    April 24, 2025
    Report Date
    May 19, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LWS
    UDI-DI
    00802526584411
    PMA / PMN Number
    P110042/S058
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT IMPLANTED WITH THIS SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) SYSTEM WAS PLANNED TO UNDERGO A MAGNETIC RESONANCE IMAGING (MRI) SCAN. HOWEVER, THE SYSTEM SHOCK IMPEDANCE VALUE WAS REPORTED AS LESS THAN 30 OHMS. TECHNICAL SERVICES DISCUSSED REASONS THE IMPEDANCE MEASUREMENT WOULD BE LOW, SUCH AS SMALL STATURE PATIENTS OR PATIENTS WITH A LOW BODY MASS INDEX (BMI), OR IF THE ELECTRODE HAD MIGRATED. AN X-RAY IN THE AP VIEW SHOWED NORMAL SYSTEM PLACEMENT, BUT NO LAT VIEW WAS TAKEN. IT WAS ALSO NOTED THAT 25 OHMS WAS THE LOWEST IN-RANGE VALUE. THE DISTRIBUTOR REPRESENTATIVE REPORTED THAT MEDICAL INTERVENTION WAS PERFORMED BY DELIVERING A 10 JOULE COMMANDED SHOCK, WITH AN IN-RANGE IMPEDANCE OF 29 OHMS. IT WAS ALSO REPORTED THAT PRIOR TO THE COMMANDED SHOCK, THE S-ECGS SHOWED DISCARDED BEATS FOR EVERY ALTERNATE R-WAVE. AFTER THE SHOCK, NO DISCARDED BEATS WERE OBSERVED, SO THERE WAS SOME CONCERN ABOUT SENSING. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED OUTSIDE OF THE COMMANDED SHOCK. THE DEVICE REMAINS IMPLANTED AND IN SERVICE. TECHNICAL SERVICES EXPLAINED THE ALTERNATE DISCARDED BEATS OBSERVATION. THE REASON FOR THE DISCARDED BEATS WAS BECAUSE THE VARIABLE INTERVAL SATISFIED THE ALTERNATING INTERVAL DOUBLE DETECTION (AIDD) ALGORITHM. THE LONG-SHORT-LONG PATTERN WAS DETECTED PRIOR TO THE SHOCK; AFTER THE SHOCK, THE R TO R INTERVAL WAS REGULAR AGAIN. THIS WAS NORMAL DEVICE FUNCTION AND THERE WERE NO ISSUES WITH SENSING FROM THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    145007 EMBLEM MRI S-ICD IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) LWS BOSTON SCIENTIFIC CORPORATION A219 126720 00802526584411

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Female Other