BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EMBLEM MRI S-ICD

    MDR report key: 11356095 · Received February 20, 2021

    Report

    Report Number
    2124215-2021-02982
    Event Type
    Injury
    Date Received
    February 20, 2021
    Date of Event
    January 19, 2021
    Report Date
    September 29, 2021
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LWS
    UDI-DI
    00802526584404
    PMA / PMN Number
    P110042/S058
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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 DURING IMPLANT OF THIS SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD), DEFIBRILLATION THRESHOLD (DFT) TESTING WAS UNSUCCESSFUL AT CONVERTING THE PATIENT WITH 80 JOULE SHOCKS. THIS S-ICD AND CHRONIC ELECTRODE ALSO EXHIBITED HIGH SHOCK IMPEDANCE MEASUREMENTS OF 142, 144 AND 150 OHMS FOLLOWING SHOCK DELIVERY. IT WAS NOTED THAT THE PATIENT HAD A LARGER CHEST SIZE. THIS S-ICD WAS ATTEMPTED, BUT NOT IMPLANTED AND THE CHRONIC ELECTRODE WAS EXPLANTED. THE PATIENT WAS IMPLANTED WITH A TRANSVENOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THE PRODUCT HAS BEEN RECEIVED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON COMPLETION OF ANALYSIS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING IMPLANT OF THIS SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD), DEFIBRILLATION THRESHOLD (DFT) TESTING WAS UNSUCCESSFUL AT CONVERTING THE PATIENT WITH 80 JOULE SHOCKS. THIS S-ICD AND CHRONIC ELECTRODE ALSO EXHIBITED HIGH SHOCK IMPEDANCE MEASUREMENTS OF 142, 144 AND 150 OHMS FOLLOWING SHOCK DELIVERY. IT WAS NOTED THAT THE PATIENT HAD A LARGER CHEST SIZE. THIS S-ICD WAS ATTEMPTED, BUT NOT IMPLANTED AND THE CHRONIC ELECTRODE WAS EXPLANTED. THE PATIENT WAS IMPLANTED WITH A TRANSVENOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THE PRODUCT HAS BEEN RECEIVED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON COMPLETION OF ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252932 EMBLEM MRI S-ICD IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) LWS BOSTON SCIENTIFIC CORPORATION A219 134287 00802526584404

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| R