BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMBLEM MRI S-ICD

    MDR report key: 25234709 · Received May 20, 2026

    Report

    Report Number
    2124215-2026-27289
    Event Type
    Malfunction
    Date Received
    May 20, 2026
    Date of Event
    April 27, 2026
    Report Date
    May 20, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LWS
    UDI-DI
    00802526584404
    PMA / PMN Number
    P110042
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IF PERTINENT INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THIS PRODUCT INVESTIGATION IS STILL IN PROGRESS. THIS REPORT WILL BE UPDATED WHEN PRODUCT INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT IMPLANTED WITH THIS SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) AND ELECTRODE HAD A RECENT CHANGE IN R-WAVE MORPHOLOGY, AND NOW THE R-WAVE WAS SHORTENED, NOTCHED, WIDE, AND NO LONGER BIPHASIC. THIS CONTRIBUTED TO OVERSENSING OF R-WAVES AND T-WAVES, RESULTING IN UNTREATED EPISODES, INAPPROPRIATE ATRIAL FIBRILLATION (AF) DETECTIONS, AND ONE INAPPROPRIATE SHOCK. THIS S-ICD WAS PROGRAMMED TO ALTERNATE, 1X. IT WAS NOTED THAT THE IMPEDANCE MEASUREMENT OF 105 OHMS. AUTOMATIC SETUP WAS PERFORMED IN CLINIC, AND ONLY SECONDARY AND ALTERNATE VECTORS PASSED. REPROGRAMMING TO 210/240 SECONDARY 2X WAS PERFORMED IN-CLINIC, AND THEY WERE ABLE TO RE-ENABLE SMART PASS WHILE PATIENT WAS LYING ON HIS SIDE. THIS S-ICD REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    598291 EMBLEM MRI S-ICD IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) LWS BOSTON SCIENTIFIC CORPORATION A219 246350 00802526584404

    Patients

    Seq Age Sex Outcome Treatment
    1