BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EMBLEM MRI S-ICD

    MDR report key: 21285893 · Received January 31, 2025

    Report

    Report Number
    2124215-2025-05063
    Event Type
    Injury
    Date Received
    January 31, 2025
    Date of Event
    January 18, 2025
    Report Date
    April 9, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LWS
    UDI-DI
    00802526581519
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    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 PATIENT CODE E060110. THIS PRODUCT HAS NOT BEEN RETURNED TO BOSTON SCIENTIFIC, AND AS A RESULT, LABORATORY ANALYSIS COULD NOT BE CONDUCTED. INVESTIGATION OF THE AVAILABLE INFORMATION DETERMINED THIS DEVICE'S DELIVERY OF A SHOCK MAY HAVE CONTRIBUTED TO UNINTENTIONAL INDUCTION OF OR ACCELERATION OF AN ARRHYTHMIA. PLEASE REFER TO THE DESCRIPTION FOR MORE INFORMATION REGARDING THE SPECIFIC CIRCUMSTANCES OF THIS EVENT. BASED ON A THOROUGH REVIEW OF THE REPORTED COMPLAINT, BOSTON SCIENTIFIC HAS ASSIGNED AN INVESTIGATION CONCLUSION CODE OF CAUSE TRACED TO DEVICE DESIGN. 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. A RISK REVIEW WAS COMPLETED AND CONFIRMED THAT THE EVENT OF DIFFICULTY CONVERTING RHYTHM (AMBULATORY) 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. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) SYSTEM EXHIBITED DIFFICULTY CONVERTING A VENTRICULAR ARRHYTHMIA. THIS DEVICE DELIVERED TWO SHOCKS RESULTING IN THE ARRHYTHMIA TO BE FASTER AND DISORGANIZED. THREE ADDITIONAL SHOCKS WERE DELIVERED HOWEVER THE ARRHYTHMIA PERSISTED. EXTERNAL DEFIBRILLATION WAS DELIVERED WITH A SINUS RHYTHM ACHIEVED. AN X-RAY WAS COMPLETED WITH CONFIRMATION THAT THE POSITION OF THE SYSTEM DOES NOT FULLY COVER THE VENTRICLE. DEVICE DATA ALSO SHOWED AN INCREASE IN IMPEDANCE MEASUREMENTS FROM THE MEASUREMENTS TAKEN AT IMPLANT. THIS SYSTEM WAS SUBSEQUENTLY PROGRAMMED OFF AND REPLACED WITH A TRANSVENOUS SYSTEM DUE TO THE CLINICAL NEEDS OF THE PATIENT. 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 DIFFICULTY CONVERTING A VENTRICULAR ARRHYTHMIA. THIS DEVICE DELIVERED TWO SHOCKS RESULTING IN THE ARRHYTHMIA TO BE FASTER AND DISORGANIZED. THREE ADDITIONAL SHOCKS WERE DELIVERED HOWEVER THE ARRHYTHMIA PERSISTED. EXTERNAL DEFIBRILLATION WAS DELIVERED WITH A SINUS RHYTHM ACHIEVED. AN X-RAY WAS COMPLETED WITH CONFIRMATION THAT THE POSITION OF THE SYSTEM DOES NOT FULLY COVER THE VENTRICLE. DEVICE DATA ALSO SHOWED AN INCREASE IN IMPEDANCE MEASUREMENTS FROM THE MEASUREMENTS TAKEN AT IMPLANT. THIS SYSTEM IS EXPECTED TO BE REVISED AT A FUTURE DATE, HOWEVER DOES REMAIN IN SERVICE. 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 DIFFICULTY CONVERTING A VENTRICULAR ARRHYTHMIA. THIS DEVICE DELIVERED TWO SHOCKS RESULTING IN THE ARRHYTHMIA TO BE FASTER AND DISORGANIZED. THREE ADDITIONAL SHOCKS WERE DELIVERED HOWEVER THE ARRHYTHMIA PERSISTED. EXTERNAL DEFIBRILLATION WAS DELIVERED WITH A SINUS RHYTHM ACHIEVED. AN X-RAY WAS COMPLETED WITH CONFIRMATION THAT THE POSITION OF THE SYSTEM DOES NOT FULLY COVER THE VENTRICLE. DEVICE DATA ALSO SHOWED AN INCREASE IN IMPEDANCE MEASUREMENTS FROM THE MEASUREMENTS TAKEN AT IMPLANT. THIS SYSTEM WAS SUBSEQUENTLY PROGRAMMED OFF AND REPLACED WITH A TRANSVENOUS SYSTEM DUE TO THE CLINICAL NEED OF THE PATIENT. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    495394 EMBLEM MRI S-ICD IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) LWS BOSTON SCIENTIFIC CORPORATION A219 172512 00802526581519

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| R