BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EMBLEM S-ICD

    MDR report key: 11698226 · Received April 20, 2021

    Report

    Report Number
    2124215-2021-09074
    Event Type
    Injury
    Date Received
    April 20, 2021
    Date of Event
    April 1, 2020
    Report Date
    October 10, 2021
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LWS
    UDI-DI
    00802526544101
    PMA / PMN Number
    P110042/S043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE DEVICE WAS PERFORMED. VISUAL INSPECTION OF THE DEVICE HEADER AND LEAD BARREL SHOWED NO ANOMALIES. THERE WERE TOOL AND ELECTROCAUTERY MARKS ON THE DEVICE CASE, MOST LIKELY INDUCED DURING THE EXPLANT PROCEDURE. TELEMETRY COULD NOT BE ESTABLISHED, AND MAGNET APPLICATION DID NOT PRODUCE THE EXPECTED AUDIBLE TONES. A RADIOFREQUENCY WAKEUP TEST WAS PERFORMED, AND NO WAKEUP PULSES WERE OBSERVED. THE DEVICE CASE WAS OPENED, AND THE BATTERY VOLTAGE WAS MEASURED AT 2.09 VOLTS WHICH WAS TOO LOW TO SUPPORT DEVICE FUNCTION. ALL THREE CELLS OF THE BATTERY WERE CONFIRMED TO BE ABNORMALLY DEPLETED. USING THE DEVICE DATA THE RANDOM ACCESS MEMORY (RAM) FIRMWARE IMAGE WAS COMPARED AGAINST THE STORED COPIES IN THE FLASH MEMORY. ANALYSIS DETERMINED THAT A SINGLE EVENT UPSET (SEU) INDUCED BIT FLIP OCCURRED AT ONE OF THE DEVICES INTERNAL CLOCKS RESPONSIBLE FOR STORING CURRENT VALUES TO VARIOUS MEMORY LOCATIONS. THE CORRUPTED VALUE AT THIS LOCATION RESULTED IN THE DEVICE NOT STORING DATA IN THE APPROPRIATE MEMORY LOCATION, LEADING THE DEVICE TO PERFORM BOTH CHARGE AND DELIVER SHOCK THERAPY INAPPROPRIATELY. IN ADDITION, ANALYSIS ALSO NOTED THAT THE MEMORY CORRUPTION LEFT THE HIGH VOLTAGE POWER SUPPLY PERSISTENTLY ENABLED FOLLOWING A CHARGING EVENT, LEAVING THE DEVICE IN A HIGH-POWER STATE WHICH SUBSEQUENTLY DEPLETED THE BATTERY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WITH THIS DEVICE SOUGHT MEDICAL ATTENTION DUE TO DEVICE SHOCKS. THE DEVICE HAS SINCE BEEN PROGRAMMED OFF AND TECHNICAL SERVICES (TS) CONTACTED FOR REVIEW AND ROOT CAUSE ASSISTANCE AS DATA FAILED TO UPLOAD FROM THE DEVICE AS EXPECTED. THE ENGINEERING LEVEL REVIEW OF DEVICE HISTORY, CONFIRMED MULTIPLE INAPPROPRIATE SHOCK THERAPIES, AS WELL AS, CORRUPTED DATA FILES. IT WAS RECOMMENDED THAT THE DEVICE BE EXPLANTED AND RETURNED FOR LABORATORY ANALYSIS, WHICH WAS LATER CONFIRMED COMPLETED. THE EXPLANTED DEVICE WAS LATER RETURNED FOR ANALYSIS AND NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Additional Manufacturer Narrative · 1

    FOLLOWING COMPLETION OF LABORATORY ANALYSIS, THIS EVENT WILL BE FURTHER UPDATED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WITH THIS DEVICE SOUGHT MEDICAL ATTENTION DUE TO DEVICE SHOCKS. THE DEVICE HAS SINCE BEEN PROGRAMMED OFF AND TECHNICAL SERVICES (TS) CONTACTED FOR REVIEW AND ASSISTANCE WITH ROOT CAUSE AS DATA FAILED TO UPLOAD FROM THE DEVICE AS EXPECTED. THE ENGINEERING LEVEL REVIEW OF DEVICE HISTORY, CONFIRMED MULTIPLE INAPPROPRIATE SHOCK THERAPIES, AS WELL AS, CORRUPTED DATA FILES. IT WAS RECOMMENDED THAT THE DEVICE BE EXPLANTED AND RETURNED FOR LABORATORY ANALYSIS, WHICH WAS LATER CONFIRMED COMPLETED. THE EXPLANTED DEVICE WAS LATER RETURNED FOR ANALYSIS AND NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    590603 EMBLEM S-ICD IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) LWS BOSTON SCIENTIFIC CORPORATION A209 204773 00802526544101

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Hospitalization| R