BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EMBLEM MRI S-ICD

    MDR report key: 20250383 · Received September 18, 2024

    Report

    Report Number
    2124215-2024-58462
    Event Type
    Injury
    Date Received
    September 18, 2024
    Date of Event
    October 1, 2020
    Report Date
    September 30, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LWS
    PMA / PMN Number
    P110042/S058
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    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 THIS SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) AND ELECTRODE EXHIBITED INCREASED SHOCK IMPEDANCE MEASUREMENTS FROM THE 77-92 OHMS RANGE AT IMPLANT, TO THE 120-150 OHMS RANGE BEGINNING APPROXIMATELY FOUR MONTHS POST IMPLANT. MEASUREMENTS REMAINED WITHIN THE 120-150 OHMS RANGE EVER SINCE. ADDITIONAL INFORMATION WAS RECEIVED SHOCK IMPEDANCE MEASUREMENTS CONTINUED TO INCREASE TO THE 200-216 OHMS RANGE. SURGICAL INTERVENTION WAS UNDERTAKEN. THE DEVICE AND ELECTRODE WERE EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THE RETURN OF THE PRODUCT HAS BEEN REQUESTED. THIS REPORT WILL BE UPDATED UPON RETURN AND COMPLETION OF ANALYSIS. ADDITIONAL INFORMATION WAS RECEIVED THAT THE ROOT CAUSE OF THE HIGH SHOCK IMPEDANCE MEASUREMENTS WAS FELT TO BE DUE TO FAT BETWEEN THE ELECTRODE COIL AND THE STERNUM. THE PRODUCT HAS BEEN RECEIVED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON COMPLETION OF ANALYSIS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) AND ELECTRODE EXHIBITED INCREASED SHOCK IMPEDANCE MEASUREMENTS FROM THE 77-92 OHMS RANGE AT IMPLANT, TO THE 120-150 OHMS RANGE BEGINNING APPROXIMATELY FOUR MONTHS POST IMPLANT. MEASUREMENTS REMAINED WITHIN THE 120-150 OHMS RANGE EVER SINCE. ADDITIONAL INFORMATION WAS RECEIVED SHOCK IMPEDANCE MEASUREMENTS CONTINUED TO INCREASE TO THE 200-216 OHMS RANGE. SURGICAL INTERVENTION WAS UNDERTAKEN. THE DEVICE AND ELECTRODE WERE EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THE RETURN OF THE PRODUCT HAS BEEN REQUESTED. THIS REPORT WILL BE UPDATED UPON RETURN AND COMPLETION OF ANALYSIS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) AND ELECTRODE EXHIBITED INCREASED SHOCK IMPEDANCE MEASUREMENTS FROM THE 77-92 OHMS RANGE AT IMPLANT, TO THE 120-150 OHMS RANGE BEGINNING APPROXIMATELY FOUR MONTHS POST IMPLANT. MEASUREMENTS REMAINED WITHIN THE 120-150 OHMS RANGE EVER SINCE. ADDITIONAL INFORMATION WAS RECEIVED SHOCK IMPEDANCE MEASUREMENTS CONTINUED TO INCREASE TO THE 200-216 OHMS RANGE. SURGICAL INTERVENTION WAS UNDERTAKEN. THE DEVICE AND ELECTRODE WERE EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THE RETURN OF THE PRODUCT HAS BEEN REQUESTED. THIS REPORT WILL BE UPDATED UPON RETURN AND COMPLETION OF ANALYSIS. ADDITIONAL INFORMATION WAS RECEIVED THAT THE ROOT CAUSE OF THE HIGH SHOCK IMPEDANCE MEASUREMENTS WAS FELT TO BE DUE TO FAT BETWEEN THE ELECTRODE COIL AND THE STERNUM. 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
    1345700 EMBLEM MRI S-ICD IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) LWS BOSTON SCIENTIFIC CORPORATION A219 255671

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Female Hospitalization| R