BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EMBLEM MRI S-ICD

    MDR report key: 21923488 · Received April 28, 2025

    Report

    Report Number
    2124215-2025-27107
    Event Type
    Injury
    Date Received
    April 28, 2025
    Date of Event
    April 20, 2025
    Report Date
    July 31, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LWS
    UDI-DI
    00802526590436
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, THIS DEVICE WAS INSPECTED AND ANALYZED. VISUAL EXAMINATION IDENTIFIED NO ANOMALIES. THE DEVICE WAS ABLE TO BE INTERROGATED AND A MEMORY DOWNLOAD WAS PERFORMED SUCCESSFULLY. THE DEVICE WAS THEN EXPOSED TO SIMULATED HEART LOAD CONDITIONS, AND THE DEFIBRILLATION AND SENSING FUNCTIONS WERE TESTED. THE DEVICE OPERATED APPROPRIATELY, ACCORDING TO ITS PERFORMANCE SPECIFICATIONS WITH NO OUT OF RANGE MEASUREMENTS OR INTERRUPTIONS IN THERAPY OUTPUT. ANALYSIS DID NOT IDENTIFY ANY DEVICE CHARACTERISTICS THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED CLINICAL OBSERVATIONS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) SYSTEM EXHIBITED INTERMITTENT, HIGH, OUT-OF-RANGE SHOCK IMPEDANCE MEASUREMENTS OF GREATER THAN 400 OHMS. X-RAY IMAGING WAS PERFORMED, AND A SLIGHT KINK IN THE ELECTRODE AS IT EXITED THE HEADER WAS NOTED. WHEN TESTING IMPEDANCE MEASUREMENTS WITH DIFFERENT MANEUVERS AND POSTURAL CHANGES, EVERYTHING APPEARED NORMAL. THERAPY WAS PROGRAMMED OFF. THE S-ICD SYSTEM REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THE S-ICD SYSTEM WAS EXPLANTED. THE PATIENT DID NOT REQUIRE A NEW DEVICE DUE TO IMPROVED EJECTION FRACTION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) SYSTEM EXHIBITED INTERMITTENT, HIGH, OUT-OF-RANGE SHOCK IMPEDANCE MEASUREMENTS OF GREATER THAN 400 OHMS. X-RAY IMAGING WAS PERFORMED, AND A SLIGHT KINK IN THE ELECTRODE AS IT EXITED THE HEADER WAS NOTED. WHEN TESTING IMPEDANCE MEASUREMENTS WITH DIFFERENT MANEUVERS AND POSTURAL CHANGES, EVERYTHING APPEARED NORMAL. THERAPY WAS PROGRAMMED OFF. THE S-ICD SYSTEM REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THE S-ICD SYSTEM WAS EXPLANTED. THE PATIENT DID NOT REQUIRE A NEW DEVICE DUE TO IMPROVED EJECTION FRACTION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) SYSTEM EXHIBITED INTERMITTENT, HIGH, OUT-OF-RANGE SHOCK IMPEDANCE MEASUREMENTS OF GREATER THAN 400 OHMS. X-RAY IMAGING WAS PERFORMED, AND A SLIGHT KINK IN THE ELECTRODE AS IT EXITED THE HEADER WAS NOTED. WHEN TESTING IMPEDANCE MEASUREMENTS WITH DIFFERENT MANEUVERS AND POSTURAL CHANGES, EVERYTHING APPEARED NORMAL. THERAPY WAS PROGRAMMED OFF. THE S-ICD SYSTEM REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1290567 EMBLEM MRI S-ICD IMPLANTABLE DEVICE LWS BOSTON SCIENTIFIC CORPORATION A219 300701 00802526590436

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Female Hospitalization| R