BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EMBLEM S-ICD

    MDR report key: 24125315 · Received January 20, 2026

    Report

    Report Number
    2124215-2026-03724
    Event Type
    Injury
    Date Received
    January 20, 2026
    Date of Event
    February 27, 2025
    Report Date
    March 17, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LWS
    UDI-DI
    00802526597305
    PMA / PMN Number
    P110042/S077
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: BASED ON THE AVAILABLE INFORMATION, ALTHOUGH NO PRODUCT HAS BEEN RETURNED AND THE PRODUCT REMAINS IMPLANTED AND IN SERVICE, WE HAVE DETERMINED THAT THE INAPPROPRIATE SHOCK IS A KNOWN INHERENT RISK WITH USE OF THIS PRODUCT. DEVICE HISTORY RECORD: A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED. THE REVIEW OF THE DHR IDENTIFIED THAT THERE WERE NO PROCESS RELATED NON-CONFORMANCES, SCRAP, OR REWORK PERFORMED DURING THE PRODUCTION THAT COULD EXPLAIN THE EVENT. THE REVIEWS ENSURE EACH DEVICE MEETS SPECIFICATION PRIOR TO RELEASE FOR USE. THERE IS NO INDICATION THE DEVICE MANUFACTURING PROCESS CONTRIBUTED TO THE REPORTED COMPLAINT. DEVICE TECHNICAL ANALYSIS: THIS DEVICE REMAINS IMPLANTED AND IN SERVICE. AS SUCH, PHYSICAL ANALYSIS HAS NOT BEEN CONDUCTED IN OUR LABORATORY. LABELING REVIEW: REVIEW OF LABELING DETERMINED THAT THE COMPLAINT SITUATION WAS LISTED IN THE MANUAL. THERE WAS NO INDICATION IN THE COMPLAINT THAT THE PRODUCT WAS NOT USED IN ACCORDANCE TO LABELING. THE MANUAL WAS UNLIKELY TO BE THE CAUSE OF THE REPORTED COMPLAINT; TRANSLATION, WORDING, OR GRAPHICS DOES NOT REQUIRE FURTHER REVIEW. INVESTIGATION CONCLUSION: THIS DEVICE REMAINS IMPLANTED AND IN SERVICE. AS SUCH, PHYSICAL ANALYSIS HAS NOT BEEN CONDUCTED IN OUR LABORATORY. RISK ASSESSMENT: A RISK REVIEW WAS COMPLETED AND CONFIRMED THAT THE EVENT OF INAPPROPRIATE SHOCK WAS DEFINED IN THE RISK DOCUMENTATION. THIS EVENT TYPE HAS BEEN ACCOUNTED FOR DURING PRODUCT RISK ANALYSIS TO SUPPORT ACCEPTABLE RISK BENEFIT FOR THE PRODUCT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS ELECTRODE AND SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) EXHIBITED OVERSENSING OF NOISE RESULTING IN DELIVERY OF AN INAPPROPRIATE SHOCK. IT WAS NOTED THAT THE PATIENT WAS USING A ROWING MACHINE AT THE TIME OF THE STORED EPISODE. THE PATIENT WAS THEN SEEN IN CLINIC APPROXIMATELY TWO MONTHS LATER. THE DEVICE WAS NOTED TO HAVE BEEN PROGRAMMED TO SECONDARY SENSING VECTOR. NOISE WAS ABLE TO BE REPRODUCED IN CLINIC. ADDITIONALLY, POOR QRS SIGNAL AMPLITUDE MEASUREMENTS WERE NOTED AND RESULTED IN UNDERSENSING. PRIMARY SENSING VECTOR APPEARED TO PROVIDE THE BEST SENSING AND DISCRIMINATION OF THE NOISE. THE DEVICE WAS REPROGRAMMED TO PRIMARY SENSING VECTOR AND MONITORING WAS CONTINUED. SUBSEQUENTLY, THE DEVICE EXHIBITED T-WAVE OVERSENSING RESULTING IN DELIVERY OF AN INAPPROPRIATE SHOCK. IT WAS NOTED THAT THE PATIENT WAS BOXING AT THE TIME. A HEALTH CARE PROFESSIONAL (HCP) NOTED THAT PROGRAMMING OPTIONS APPEAR LIMITED FOR THIS PATIENT. THE HCP PLANNED TO HAVE FURTHER DISCUSSIONS WITH THE CLINIC PHYSICIANS REGARDING ANY POTENTIAL OPTIONS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS DEVICE REMAINS IN SERVICE. IF PERTINENT INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. ADDITIONAL INFORMATION WAS RECEIVED THAT NO FURTHER PROGRAMMING OPTIONS ARE AVAILABLE FOR THIS SYSTEM AND PATIENT. THE PHYSICIAN AND TEAM IS CONSIDERING POTENTIAL S-ICD SYSTEM EXPLANT AND IMPLANT OF A TRANSVENOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM. AVAILABLE INFORMATION INDICATES THAT THIS PRODUCT REMAINS IN SERVICE. IF PERTINENT INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS ELECTRODE AND SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) EXHIBITED OVERSENSING OF NOISE RESULTING IN DELIVERY OF AN INAPPROPRIATE SHOCK. IT WAS NOTED THAT THE PATIENT WAS USING A ROWING MACHINE AT THE TIME OF THE STORED EPISODE. THE PATIENT WAS THEN SEEN IN CLINIC APPROXIMATELY TWO MONTHS LATER. THE DEVICE WAS NOTED TO HAVE BEEN PROGRAMMED TO SECONDARY SENSING VECTOR. NOISE WAS ABLE TO BE REPRODUCED IN CLINIC. ADDITIONALLY, POOR QRS SIGNAL AMPLITUDE MEASUREMENTS WERE NOTED AND RESULTED IN UNDERSENSING. PRIMARY SENSING VECTOR APPEARED TO PROVIDE THE BEST SENSING AND DISCRIMINATION OF THE NOISE. THE DEVICE WAS REPROGRAMMED TO PRIMARY SENSING VECTOR AND MONITORING WAS CONTINUED. SUBSEQUENTLY, THE DEVICE EXHIBITED T-WAVE OVERSENSING RESULTING IN DELIVERY OF AN INAPPROPRIATE SHOCK. IT WAS NOTED THAT THE PATIENT WAS BOXING AT THE TIME. A HEALTH CARE PROFESSIONAL (HCP) NOTED THAT PROGRAMMING OPTIONS APPEAR LIMITED FOR THIS PATIENT. THE HCP PLANNED TO HAVE FURTHER DISCUSSIONS WITH THE CLINIC PHYSICIANS REGARDING ANY POTENTIAL OPTIONS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS DEVICE REMAINS IN SERVICE. IF PERTINENT INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. ADDITIONAL INFORMATION WAS RECEIVED THAT NO FURTHER PROGRAMMING OPTIONS ARE AVAILABLE FOR THIS SYSTEM AND PATIENT. THE PHYSICIAN AND TEAM IS CONSIDERING POTENTIAL S-ICD SYSTEM EXPLANT AND IMPLANT OF A TRANSVENOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM. AVAILABLE INFORMATION INDICATES THAT THIS PRODUCT REMAINS IN SERVICE. IF PERTINENT INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55844 EMBLEM S-ICD IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) LWS BOSTON SCIENTIFIC CORPORATION 3501 197713 00802526597305

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Unknown Life Threatening