BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EMBLEM MRI S-ICD

    MDR report key: 17836103 · Received September 28, 2023

    Report

    Report Number
    2124215-2023-53396
    Event Type
    Injury
    Date Received
    September 28, 2023
    Date of Event
    September 20, 2023
    Report Date
    January 16, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LWS
    UDI-DI
    00802526584404
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    THE RETURNED DEVICE WAS THOROUGHLY INSPECTED AND ANALYZED. VISUAL INSPECTION 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 THIS SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) WAS IMPLANTED IN WHICH 3 DEFIBRILLATION THRESHOLD (DFT) TESTS WERE ATTEMPTED AND UNSUCCESSFUL. THIS PATIENT WAS BROUGHT BACK THE NEXT DAY FOR NON-INVASIVE PROGRAMMED STIMULATION (NIPS) TESTING AND ADDITIONAL DFT WAS PERFORMED AND UNSUCCESSFUL. THE ELECTRODE WAS REVISED AND MOVED AND DFT PERFORMED AFTER WHICH WAS AGAIN UNSUCCESSFUL. THE PHYSICIAN OPTED TO REMOVE THE S-ICD SYSTEM AND REPLACE WITH A TRANSVENOUS (TV) SYSTEM IN WHICH A SUCCESSFUL DFT WAS PERFORMED. THE TV SYSTEM REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) WAS IMPLANTED IN WHICH 3 DEFIBRILLATION THRESHOLD (DFT) TESTS WERE ATTEMPTED AND UNSUCCESSFUL. THIS PATIENT WAS BROUGHT BACK THE NEXT DAY FOR NON-INVASIVE PROGRAMMED STIMULATION (NIPS) TESTING AND ADDITIONAL DFT WAS PERFORMED AND UNSUCCESSFUL. THE ELECTRODE WAS REVISED AND MOVED AND DFT PERFORMED AFTER WHICH WAS AGAIN UNSUCCESSFUL. THE PHYSICIAN OPTED TO REMOVE THE S-ICD SYSTEM AND REPLACE WITH A TRANSVENOUS (TV) SYSTEM IN WHICH A SUCCESSFUL DFT WAS PERFORMED. THE TV SYSTEM REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2063146 EMBLEM MRI S-ICD IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) LWS BOSTON SCIENTIFIC CORPORATION A219 190613 00802526584404

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Male Required Intervention| H