BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EMBLEM MRI S-ICD

    MDR report key: 19431028 · Received May 30, 2024

    Report

    Report Number
    2124215-2024-33028
    Event Type
    Injury
    Date Received
    May 30, 2024
    Date of Event
    May 18, 2024
    Report Date
    June 18, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE MEMORY ANALYSIS IDENTIFIED AN ERROR. THE ERROR RESULTED IN SOFTWARE RESETS PERFORMED IN AN ATTEMPT TO CORRECT AN IDENTIFIED MEMORY INCONSISTENCY. THE DEVICE ALSO PROVIDED INAPPROPRIATE ELECTRIC SHOCKS DUE TO NOISE OVERSENSING. THE CAUSE OF THE MEMORY INCONSISTENCY WAS NOT ABLE TO BE DETERMINED BUT WAS LIKELY THE RESULT OF A SINGLE EVENT UPSET CAUSED BY HIGH ENERGY PARTICLES IN THE ENVIRONMENT. THESE PARTICLES TYPICALLY ARISE FROM THERAPEUTIC IONIZING RADIATION, NATURALLY OCCURRING HIGH ENERGY PARTICLES/COSMIC RAYS, OR RADIOACTIVE DECAYING MATERIALS. IN MOST CASES THE S-ICD IS ABLE TO DETECT AND SELF-CORRECT TO MAINTAIN PRIMARY OPERATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT APPROXIMATELY 30 MINUTES AFTER THE PATIENT RADIOTHERAPY SESSION, THIS SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) DEVICE DELIVERED 12 CONSECUTIVE SHOCKS WHILE THE PATIENT WAS DRIVING. THE PATIENT THEN PRESENTED TO THE EMERGENCY ROOM TO CHECK THE DEVICE AND IT WAS OBSERVED THAT THERE WERE NO ELECTROGRAMS (EGMS) STORED RELATED TO THE SHOCKS. A COMMANDED SHOCK WAS REQUIRED TO CONVERT THE ARRHYTHMIA. THE PATIENT WAS HOSPITALIZED AND THE DEVICE DATA SENT TO TECHNICAL SERVICES (TS) FOR REVIEW. TS CONFIRMED THE DEVICE ERROR RESETS AND FORWARDED THE DATA FOR ENGINEERING ANALYSIS. ENGINEERS REVIEWED THE MEMORY DATA AND CONFIRMED THAT THIS DEVICE EXPERIENCED A MEMORY CORRUPTION RELATED TO A SINGLE EVENT UPSET (SEU), WHICH IS LIKELY TO BE RELATED TO THE RADIATION THERAPY EXPOSITION. THE DEVICE WAS OBSERVED TO RECOVER NORMAL OPERATION AFTER THE PERIODIC DEVICE INTEGRITY CHECK AUTOMATICALLY PERFORMED AN INTERNAL RESET FUNCTION. ENGINEERS ALSO CONFIRMED THAT DEVICE CAN BE LEFT IMPLANTED ACCORDING TO PHYSICIAN CONSIDERATION. IT WAS ALSO RECOMMENDED THAT IF THE PATIENT IS REQUIRED TO PERFORM FURTHER THERAPY RADIATION TREATMENT, TO PERFORM 60-60 MAGNET RESET SOON AFTER THERAPY CONCLUSION BEFORE PATIENT LEAVES THE TREATMENT CENTER IN THE WAY TO MINIMIZE POTENTIAL RISK OF EFFECT FROM POSSIBLE MEMORY CORRUPTION. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL AND THE S-ICD REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT APPROXIMATELY 30 MINUTES AFTER THE PATIENT RADIOTHERAPY SESSION, THIS SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) DEVICE DELIVERED 12 CONSECUTIVE SHOCKS WHILE THE PATIENT WAS DRIVING. THE PATIENT THEN PRESENTED TO THE EMERGENCY ROOM TO CHECK THE DEVICE AND IT WAS OBSERVED THAT THERE WERE NO ELECTROGRAMS (EGMS) STORED RELATED TO THE SHOCKS. A COMMANDED SHOCK WAS REQUIRED TO CONVERT THE ARRHYTHMIA. THE PATIENT WAS HOSPITALIZED AND THE DEVICE DATA SENT TO TECHNICAL SERVICES (TS) FOR REVIEW. TS CONFIRMED THE DEVICE ERROR RESETS AND FORWARDED THE DATA FOR ENGINEERING ANALYSIS. ENGINEERS REVIEWED THE MEMORY DATA AND CONFIRMED THAT THIS DEVICE EXPERIENCED A MEMORY CORRUPTION RELATED TO A SINGLE EVENT UPSET (SEU), WHICH IS LIKELY TO BE RELATED TO THE RADIATION THERAPY EXPOSITION. THE DEVICE WAS OBSERVED TO RECOVER NORMAL OPERATION AFTER THE PERIODIC DEVICE INTEGRITY CHECK AUTOMATICALLY PERFORMED AN INTERNAL RESET FUNCTION. ENGINEERS ALSO CONFIRMED THAT DEVICE CAN BE LEFT IMPLANTED ACCORDING TO PHYSICIAN CONSIDERATION. IT WAS ALSO RECOMMENDED THAT IF THE PATIENT IS REQUIRED TO PERFORM FURTHER THERAPY RADIATION TREATMENT, TO PERFORM 60-60 MAGNET RESET SOON AFTER THERAPY CONCLUSION BEFORE PATIENT LEAVES THE TREATMENT CENTER IN THE WAY TO MINIMIZE POTENTIAL RISK OF EFFECT FROM POSSIBLE MEMORY CORRUPTION. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL AND THE S-ICD REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1258190 EMBLEM MRI S-ICD SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) LWS BOSTON SCIENTIFIC CORPORATION A219 189434

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| O