BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EMBLEM MRI S-ICD

    MDR report key: 17102504 · Received June 11, 2023

    Report

    Report Number
    2124215-2023-29898
    Event Type
    Injury
    Date Received
    June 11, 2023
    Date of Event
    April 25, 2023
    Report Date
    February 21, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LWS
    PMA / PMN Number
    P110042/S058
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SENT TO CORRECT D6B. THIS REPORT IS BEING SENT TO PROVIDE NEW INFORMATION IN SECTIONS B5 (EVENT DESCRIPTION), D9 (DEVICE AVAIL FOR EVALUATION AND RETURNED TO MANUFACTURER DATE), H3 (DEVICE EVAL BY MANUFACTURER), H6 (COMPONENT CODES, EVALUATION METHOD CODES, EVALUATION RESULT CODES, AND EVALUATION CONCLUSION CODES), AND H11 (ADDITIONAL MFR NARRATIVE). THE RETURNED S-ICD WAS THOROUGHLY INSPECTED AND ANALYZED. 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. ALTHOUGH THE S-ICD AND ELECTRODE OPERATED APPROPRIATELY IN THE LABORATORY SETTING, ENGINEERS SUSPECT THERE MAY HAVE BEEN A PROBLEM WITH THE ELECTRODE/S-ICD INTERFACE WHILE THE PRODUCTS WERE IMPLANTED, RESULTING IN TRANSIENT CHANGES IN THE IMPEDANCE PATHWAY OF THE SENSING VECTOR THAT UTILIZES THE PROXIMAL SENSING ELECTRODE (SENSE B). THESE CHANGES IN THE IMPEDANCE PATHWAY MAY HAVE CONTRIBUTED TO THE NOISE AND OVER-SENSING NOTED IN THE FIELD; HOWEVER, A DEFINITIVE CAUSE OF THIS SENSING BEHAVIOR HAS NOT BEEN DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A REMOTE DEVICE DATA REVIEW, TWO EPISODES OF OVER-SENSED NON-PHYSIOLOGICAL NOISE WERE NOTED FROM THIS SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEM. THE EPISODES WERE UNTREATED AND DID NOT LEAD TO INAPPROPRIATE THERAPY. TECHNICAL SERVICES WAS CONTACTED AND PROVIDED THOROUGH IN-CLINIC TROUBLESHOOTING MEASURES TO ASSESS THE SYSTEM INTEGRITY. DIAGNOSTIC IMAGING WAS PERFORMED WHICH SHOWED A POTENTIAL FRACTURE NEAR THE SENSE A NODE OF THE S-ICD ELECTRODE. THE PHYSICIAN ELECTED TO SURGICALLY EXPLANT AND REPLACE THE ENTIRE S-ICD SYSTEM TO RESOLVE THE EVENT AND NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THE EXPLANTED S-ICD SYSTEM IS EXPECTED TO BE RETURNED FOR ANALYSIS, BUT HAS NOT YET BEEN RECEIVED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A REMOTE DEVICE DATA REVIEW, TWO EPISODES OF OVER-SENSED NON-PHYSIOLOGICAL NOISE WERE NOTED FROM THIS SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEM. THE EPISODES WERE UNTREATED AND DID NOT LEAD TO INAPPROPRIATE THERAPY. TECHNICAL SERVICES WAS CONTACTED AND PROVIDED THOROUGH IN-CLINIC TROUBLESHOOTING MEASURES TO ASSESS THE SYSTEM INTEGRITY. DIAGNOSTIC IMAGING WAS PERFORMED WHICH SHOWED A POTENTIAL FRACTURE NEAR THE SENSE A NODE OF THE S-ICD ELECTRODE. THE PHYSICIAN ELECTED TO SURGICALLY EXPLANT AND REPLACE THE ENTIRE S-ICD SYSTEM TO RESOLVE THE EVENT AND NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THE EXPLANTED S-ICD SYSTEM IS EXPECTED TO BE RETURNED FOR ANALYSIS, BUT HAS NOT YET BEEN RECEIVED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A REMOTE DEVICE DATA REVIEW, TWO EPISODES OF OVER-SENSED NON-PHYSIOLOGICAL NOISE WERE NOTED FROM THIS SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEM. THE EPISODES WERE UNTREATED AND DID NOT LEAD TO INAPPROPRIATE THERAPY. TECHNICAL SERVICES WAS CONTACTED AND PROVIDED THOROUGH IN-CLINIC TROUBLESHOOTING MEASURES TO ASSESS THE SYSTEM INTEGRITY. DIAGNOSTIC IMAGING WAS PERFORMED WHICH SHOWED A POTENTIAL FRACTURE NEAR THE SENSE A NODE OF THE S-ICD ELECTRODE. THE PHYSICIAN ELECTED TO SURGICALLY EXPLANT AND REPLACE THE ENTIRE S-ICD SYSTEM TO RESOLVE THE EVENT AND NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THE EXPLANTED S-ICD SYSTEM WAS RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1957085 EMBLEM MRI S-ICD IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) LWS BOSTON SCIENTIFIC CORPORATION A219 228494

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Unknown Required Intervention| H