BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EMBLEM? MRI S-ICD

    MDR report key: 20789614 · Received November 26, 2024

    Report

    Report Number
    2124215-2024-74732
    Event Type
    Injury
    Date Received
    November 26, 2024
    Date of Event
    September 20, 2024
    Report Date
    April 14, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LWS
    UDI-DI
    00802526584404
    PMA / PMN Number
    P110042
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    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 E210401. 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 OVERSENSING 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. THE DEVICE WAS NOT RETURNED FOR ANALYSIS; 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 THE PATIENT WITH THIS SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (SICD) SYSTEM RECEIVED EIGHT INAPPROPRIATE SHOCKS ACROSS SIX VENTRICULAR TACHYCARDIA (VT) EPISODES DUE TO OVERSENSING OF NOISY SIGNALS. THE PATIENT HAD NOISE IN BOTH SECONDARY AND ALTERNATE VECTOR WHILE SITTING. TECHNICAL SERVICES (TS) WAS CONSULTED, DISCUSSED IT LOOKS LIKE POCKET FRACTURE. TS DISCUSSED POSSIBLE REPROGRAMMING OPTIONS AND RECOMMENDED ELECTRODE REPLACEMENT. THIS SICD REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED, THIS SICD SYSTEM WAS SUBSEQUENTLY EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WITH THIS SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (SICD) SYSTEM RECEIVED EIGHT INAPPROPRIATE SHOCKS ACROSS SIX VENTRICULAR TACHYCARDIA (VT) EPISODES DUE TO OVERSENSING OF NOISY SIGNALS. THE PATIENT HAD NOISE IN BOTH SECONDARY AND ALTERNATE VECTOR WHILE SITTING. TECHNICAL SERVICES (TS) WAS CONSULTED, DISCUSSED IT LOOKS LIKE POCKET FRACTURE. TS DISCUSSED POSSIBLE REPROGRAMMING OPTIONS AND RECOMMENDED ELECTRODE REPLACEMENT. THIS SICD REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WITH THIS SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (SICD) SYSTEM RECEIVED EIGHT INAPPROPRIATE SHOCKS ACROSS SIX VENTRICULAR TACHYCARDIA (VT) EPISODES DUE TO OVERSENSING OF NOISY SIGNALS. THE PATIENT HAD NOISE IN BOTH SECONDARY AND ALTERNATE VECTOR WHILE SITTING. TECHNICAL SERVICES (TS) WAS CONSULTED, DISCUSSED IT LOOKS LIKE POCKET FRACTURE. TS DISCUSSED POSSIBLE REPROGRAMMING OPTIONS AND RECOMMENDED ELECTRODE REPLACEMENT. THIS SICD REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED, THIS SICD SYSTEM WAS SUBSEQUENTLY EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    400226 EMBLEM? MRI S-ICD IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) LWS BOSTON SCIENTIFIC CORPORATION A219 251239 00802526584404

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Male Other| R| H