BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EMBLEM S-ICD

    MDR report key: 20014335 · Received August 21, 2024

    Report

    Report Number
    2124215-2024-51519
    Event Type
    Injury
    Date Received
    August 21, 2024
    Date of Event
    August 8, 2024
    Report Date
    April 28, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LWS
    UDI-DI
    00802526548406
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT WAS AMENDED TO UPDATE INTERNATIONAL MEDICAL DEVICE REGULATORS FORUM (IMDRF) CODES. INCOMPLETE CODING OF THIS EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF COMPLAINTS ASSOCIATED WITH CAPA-8580, WHICH FOCUSED ON IDENTIFYING AND REMEDIATING INCOMPLETE CODING OF EVENTS. ADDED DEVICE A070909 AND A090801. 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. PRODUCT RISK BENEFIT INCLUDES CONSIDERATION OF RISK SEVERITY AND RATE, AND THE OVERALL RESIDUAL RISK OF THE DEVICE IS ACCEPTABLE. A RISK REVIEW PERFORMED FOR THE EMBLEM S-ICD DEVICE CONFIRMED THAT THE EVENT OF INAPPROPRIATE SHOCK IS A KNOWN EVENT DEFINED IN THE PRODUCTS RISK MANAGEMENT DOCUMENTATION. THIS EVENT TYPE HAS BEEN ACCOUNTED FOR DURING PRODUCT RISK ANALYSIS TO SUPPORT ACCEPTABLE RISK BENEFIT FOR THE PRODUCT. PRODUCT RISK BENEFIT INCLUDES CONSIDERATION OF RISK SEVERITY AND RATE, AND THE OVERALL RESIDUAL RISK OF THE EMBLEM S-ICD DEVICE IS ACCEPTABLE. 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. THE DEVICE REMAINS IMPLANTED AND IN SERVICE; THEREFORE, A TECHNICAL ANALYSIS COULD NOT BE PERFORMED. BASED ON A THOROUGH REVIEW OF THE REPORTED COMPLAINT, BOSTON SCIENTIFIC HAS ASSIGNED AN INVESTIGATION CONCLUSION CODE OF KNOWN INHERENT RISK OF DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) EXHIBITED UNDERSENSING OF VARIABLE MORPHOLOGIES RESULTING IN AN INAPPROPRIATE SHOCK. DEVICE DATA WAS SENT TO RHYTHMCARE FOR REVIEW. RHYTHMCARE THEN PROVIDED FURTHER TROUBLESHOOTING STEPS. THIS DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) EXHIBITED UNDERSENSING OF VARIABLE MORPHOLOGIES RESULTING IN AN INAPPROPRIATE SHOCK. DEVICE DATA WAS SENT TO RHYTHMCARE FOR REVIEW. RHYTHMCARE THEN PROVIDED FURTHER TROUBLESHOOTING STEPS. ADDITIONAL INFORMATION WAS RECEIVED THAT THIS DEVICE EXHIBITED OVERSENSING OF A VENTRICULAR ARRHYTHMIA RESULTING IN ANOTHER INAPPROPRIATE SHOCK. PROGRAMMING CHANGES ARE EXPECTED AT THE NEXT FOLLOW UP APPOINTMENT. THIS DEVICE REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT IMPLANTED WITH THIS SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) RECEIVED A SHOCK FROM THE DEVICE AND THE PHYSICIAN WANTED TO UNDERSTAND WHY THE THERAPY WAS DELIVERED. TECHNICAL SERVICES REVIEWED THE EPISODE AND CONFIRMED NORMAL DEVICE FUNCTION. THERE WAS SOME INITIAL UNDERSENSING OF VARIABLE MORPHOLOGIES, BUT THEN THE MORPHOLOGY STABILIZED AND THE SENSING IS APPROPRIATE, THE HEART RATE WAS APPROXIMATELY 230-245 BPM, RESULTING IN THE DEVICE TO USE THE MORE SENSITIVE SENSING PROFILE. THE ARRHYTHMIA APPEARED TO BE A FAST, POLYMORPHIC, NON-SINUS RHYTHM WITH AN APPROPRIATE SHOCK. HOWEVER, TWO MONTHS LATER, THE PATIENT RECEIVED AN INAPPROPRIATE SHOCK WHERE T-WAVE OVERSENSING WAS OBSERVED. TECHNICAL SERVICES RECOMMENDED EVALUATING THE OTHER SENSE VECTORS AND EXTENDING SMART CHARGE TO DELAY THERAPY FOR THIS TYPE OF RHYTHM. ONE YEAR LATER, THE PATIENT RECEIVED ANOTHER INAPPROPRIATE SHOCK, THIS TIME DUE TO OVERSENSING OF A NON-PHYSIOLOGIC ARTIFACT. TECHNICAL SERVICES RECOMMENDED FINDING OUT WHAT THE PATIENT WAS DOING AT THE TIME OF THE SHOCK. AT THIS TIME, THE DEVICE REMAINS IMPLANTED AND IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED OUTSIDE OF THE INAPPROPRIATE SHOCK THERAPIES THAT WERE RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601398 EMBLEM S-ICD IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) LWS BOSTON SCIENTIFIC CORPORATION A209 198564 00802526548406

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other