BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EMBLEM S-ICD

    MDR report key: 23791291 · Received December 12, 2025

    Report

    Report Number
    2124215-2025-90635
    Event Type
    Injury
    Date Received
    December 12, 2025
    Date of Event
    November 21, 2025
    Report Date
    March 25, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LWS
    UDI-DI
    00802526599200
    PMA / PMN Number
    P110042
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE RETURNED ELECTRODE WAS THOROUGHLY INSPECTED AND ANALYZED. RESISTANCE TESTS WERE COMPLETED TO ASSESS ELECTRICAL PERFORMANCE AND INNER INSULATION INTEGRITY. MEASUREMENTS THROUGHOUT THESE TESTS WERE WITHIN NORMAL LIMITS. MICROSCOPIC INSPECTIONS OF THE TERMINAL PIN ASSEMBLY AND ELECTRODE BODY FOUND NO ANOMALIES. LABORATORY ANALYSIS DID NOT IDENTIFY ANY ELECTRODE CHARACTERISTICS THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED CLINICAL OBSERVATIONS. 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. (B)(6) 2025 - EXPLANT PERFORMED. CGJ.

    Additional Manufacturer Narrative · 0

    (B)(6) 2025 - EXPLANT PERFORMED. CGJ.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) SYSTEM EXHIBITED SOME UNTREATED EPISODES AND A TREATED EPISODE. UPON REVIEW, IT WAS NOTED NOISE OVERSENSED IN ALL EPISODES. THE PATIENT WAS BROUGHT INTO THE CLINIC, NOISE WITH POCKET MANIPULATION IN ALL VECTORS WERE PERFORMED. A X-RAY WAS PERFORMED AND IT WAS NOTED SOME TENSION WHERE THE TUNNEL TRACK ENTERED THE POCKET. IT HAD BEEN A PEDIATRIC IMPLANT, AND NORMAL BODY GROWTH COULD HAVE CONTRIBUTED. THE PATIENT ALSO APPEARED TO HAVE PECTUS EXCAVATUM. IT WAS ALSO NOTED THAT THE ELECTRODE COULD HAVE BEEN POSITIONED LOWER, AS IT SEEMED SLIGHTLY HIGH, POSSIBLY DUE TO THE GROWTH OF THE PATIENT. THE DEVICE WAS PROGRAMMED OFF AND THE PATIENT WAS PLACED ON A LIFE VEST AWAITING THE ADVANCE CARE. SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED, AND THE S-ICD SYSTEM WAS EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) SYSTEM EXHIBITED SOME UNTREATED EPISODES AND A TREATED EPISODE. UPON REVIEW, IT WAS NOTED NOISE OVERSENSED IN ALL EPISODES. THE PATIENT WAS BROUGHT INTO THE CLINIC, NOISE WITH POCKET MANIPULATION IN ALL VECTORS WERE PERFORMED. A X-RAY WAS PERFORMED AND IT WAS NOTED SOME TENSION WHERE THE TUNNEL TRACK ENTERED THE POCKET. IT HAD BEEN A PEDIATRIC IMPLANT, AND NORMAL BODY GROWTH COULD HAVE CONTRIBUTED. THE PATIENT ALSO APPEARED TO HAVE PECTUS EXCAVATUM. IT WAS ALSO NOTED THAT THE ELECTRODE COULD HAVE BEEN POSITIONED LOWER, AS IT SEEMED SLIGHTLY HIGH, POSSIBLY DUE TO THE GROWTH OF THE PATIENT. THE DEVICE WAS PROGRAMMED OFF AND THE PATIENT WAS PLACED ON A LIFE VEST AWAITING THE ADVANCE CARE. CURRENTLY, THIS PRODUCT REMAINS IN SERVICE AND NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) SYSTEM EXHIBITED SOME UNTREATED EPISODES AND A TREATED EPISODE. UPON REVIEW, IT WAS NOTED NOISE OVERSENSED IN ALL EPISODES. THE PATIENT WAS BROUGHT INTO THE CLINIC, NOISE WITH POCKET MANIPULATION IN ALL VECTORS WERE PERFORMED. A X-RAY WAS PERFORMED AND IT WAS NOTED SOME TENSION WHERE THE TUNNEL TRACK ENTERED THE POCKET. IT HAD BEEN A PEDIATRIC IMPLANT, AND NORMAL BODY GROWTH COULD HAVE CONTRIBUTED. THE PATIENT ALSO APPEARED TO HAVE PECTUS EXCAVATUM. IT WAS ALSO NOTED THAT THE ELECTRODE COULD HAVE BEEN POSITIONED LOWER, AS IT SEEMED SLIGHTLY HIGH, POSSIBLY DUE TO THE GROWTH OF THE PATIENT. THE DEVICE WAS PROGRAMMED OFF AND THE PATIENT WAS PLACED ON A LIFE VEST AWAITING THE ADVANCE CARE. SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED, AND THE S-ICD SYSTEM WAS EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2761836 EMBLEM S-ICD IMPLANTABLE ELECTRODE LWS BOSTON SCIENTIFIC CORPORATION 3501 184800 00802526599200

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Unknown Other| H| R