BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EMBLEM MRI S-ICD

    MDR report key: 23799995 · Received December 15, 2025

    Report

    Report Number
    2124215-2025-90734
    Event Type
    Injury
    Date Received
    December 15, 2025
    Date of Event
    November 20, 2025
    Report Date
    December 14, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LWS
    UDI-DI
    00802526581519
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE PATIENT THAT HE WAS EXERCISING WHEN HE STARTED TO FEEL DIZZY AND SHORT OF BREATH. HIS HEART RATE WAS 195 BEATS/MINUTE. AN AMBULANCE WAS CALLED, AND THE PATIENT SUBSEQUENTLY RECEIVED EXTERNAL CARDIOVERSION AND MEDICATION (VALIUM). TECHNICAL SERVICES REVIEW OF THE SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) CONFIRMED THAT THE PROGRAMMED CONDITIONAL SHOCK AND TREATMENT ZONES WERE SET TO 220 BEATS/MINUTE AND 250 BEATS/MINUTE RESPECTIVELY AND THUS THE S-ICD HAD NOT PROVIDED THERAPY. THE PATIENT WAS FROM AUSTRALIA AND HAD BEEN TRAVELING IN THAILAND AT THE TIME OF THE EVENT. HE WAS INSTRUCTED TO FOLLOW-UP WITH HIS NORMAL PHYSICIAN UPON RETURNING TO AUSTRALIA (RETURN ON (B)(6)). THE S-ICD REMAINS IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    766143 EMBLEM MRI S-ICD IMPLANTABLE DEVICE LWS BOSTON SCIENTIFIC CORPORATION A219 321885 00802526581519

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Unknown Hospitalization| R