BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCOLADE? MRI EL DR

    MDR report key: 24226616 · Received January 30, 2026

    Report

    Report Number
    2124215-2026-05640
    Event Type
    Injury
    Date Received
    January 30, 2026
    Date of Event
    January 7, 2026
    Report Date
    January 30, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LWP
    UDI-DI
    00802526559266
    PMA / PMN Number
    P150012
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS PACEMAKER WAS FOUND TO BE IN SAFETY MODE. THE PATIENT ADVOCATE FIRST NOTICED THAT THE COMMUNICATOR SHOWED A YELLOW COLLECTING WAVE ICON (YCW). THE CLINIC ALLOWED ONE PATIENT INITIATED INTERROGATION (PII). A COMMUNICATOR POWER CYCLE WAS PERFORMED. A COMMUNICATOR FORCED CALL WAS PERFORMED. A PII WAS PERFORMED, BUT A YCW WAS STILL SHOWING. THE COMMUNICATOR WAS MOVED TO ANOTHER ROOM, BUT THE ISSUE REMAINED. THE ISSUE WAS REFERRED TO HIGHER TECHNICAL SUPPORT TO ANALYZE THE YCW. ADDITIONAL INFORMATION INDICATES THAT THE RADIO FREQUENCY DIAGNOSTIC SHOWED NO RADIO FREQUENCY INTERFERENCE, BUT THERE WAS ONE BLOCKED PII. THE HOME ENVIRONMENT SEEMS UNLIKELY TO CAUSE, AND THE PATIENT WAS ADVISED TO WORK WITH THE CLINIC TO VERIFY THE RADIO FREQUENCY SETTINGS OF THE IMPLANTED DEVICE. THIS TROUBLESHOOTING WAS DISCUSSED WITH THE PATIENT'S HEALTH CARE PROFESSIONAL (HCP) WHILE THE PATIENT WAS OUT OF THE STATE. TECHNICAL SERVICES (TS) NOTED THE PATIENT WAS DEPENDENT AND AN URGENT CHANGEOUT WAS RECOMMENDED. SUBSEQUENTLY, THIS DEVICE WAS EXPLANTED AND REPLACED ONCE SAFETY MODE WAS CONFIRMED. THERE WAS OVER 2 SECONDS OF PACING INHIBITION NOTED. THIS PACEMAKER HAS NOT BEEN RECEIVED FOR INVESTIGATION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290185 ACCOLADE? MRI EL DR IMPLANTABLE PACEMAKER LWP BOSTON SCIENTIFIC CORPORATION L331 693180 00802526559266

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male Hospitalization| R