BEUDAMED
    FDA Adverse Event Death Summary report: N

    S-ICD SYSTEM

    MDR report key: 6603226 · Received May 31, 2017

    Report

    Report Number
    2124215-2017-09542
    Event Type
    Death
    Date Received
    May 31, 2017
    Date of Event
    May 2, 2017
    Report Date
    May 5, 2017
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND CLONMEL
    Product Code
    LWS
    UDI-DI
    00802526544101
    PMA / PMN Number
    P110042/S043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN ENGINEERING-LEVEL PROGRAMMER WAS USED TO INTERROGATE THE S-ICD AND DOWNLOAD THE DEVICE MEMORY. ANALYSIS REVEALED THAT THE BATTERY WAS DEPLETED, AS WELL AS EXTENSIVE RANDOM ACCESS MEMORY (RAM) CORRUPTION CONSISTENT WITH A TEMPORARY LOSS OF POWER REQUIRED TO SUPPORT DEVICE MEMORY. DEVICE FIRMWARE LOG ENTRIES SUGGESTED THAT THE S-ICD MAY HAVE BEEN IN AN INDUCTION STATE AT THE TIME THE LOSS OF POWER OCCURRED. THERE WAS NO STORED EPISODE DATA IDENTIFIED IN THE DEVICE'S MEMORY. VISUAL INSPECTION AND X-RAY EXAMINATION OF THIS S-ICD DID NOT INDICATE ANY ANOMALIES. DETAILED FUNCTIONAL AND ELECTRICAL TESTS WERE CONDUCTED; THE S-ICD FIRMWARE OPERATION, TELEMETRY, SENSING, IMPEDANCE, AND LOW ENERGY SHOCKING FUNCTIONS WERE FOUND TO BE OPERATING NORMALLY. FULL ENERGY SHOCKS WERE NOT ATTEMPTED DUE TO THE DEVICE'S DEPLETED BATTERY STATUS. THE DEVICE CASE WAS REMOVED AND INTERNAL VISUAL INSPECTION REVEALED NO ANOMALIES WITH THE INTERNAL COMPONENTS. AN EXTERNAL POWER SUPPLY WAS CONNECTED TO THE HYBRID ASSEMBLY; POWER CONSUMPTION WAS TESTED AND NOTED AS NORMAL. THE POWER SUPPLIES WERE OPERATING AT THE SPECIFIED VOLTAGE. THE CIRCUIT BOARD WAS UNFOLDED AND INSPECTED UNDER REAL-TIME X-RAY, NO ABNORMALITIES WERE IDENTIFIED. LABORATORY ANALYSIS OF THE ELECTRODE ASSOCIATED WITH THIS S-ICD CONFIRMED THAT THE ELECTRICAL PARAMETERS OF THE ELECTRODE WERE WITHIN SPECIFICATION. HOWEVER, SIGNIFICANT CORROSION OF THE SHOCKING COIL WAS NOTED. COLLECTIVELY, THE REPORTED CLINICAL OBSERVATIONS, REVIEW OF THE DEVICE MEMORY, AND RETURNED PRODUCT ANALYSIS RESULTS INDICATE THAT THIS S-ICD DELIVERED AN ATYPICAL AMOUNT OF ENERGY. THIS ACCOUNTS FOR CORROSION OF THE ASSOCIATED ELECTRODE, DEPLETION OF THE S-ICD BATTERY, TEMPORARY LOSS OF POWER, AND A DEVICE RESET. THE RESET SUBSEQUENTLY RESTORED NORMAL DEVICE OPERATION. ENGINEERS DETERMINED THIS EVENT WAS LIKELY DUE TO A TRANSIENT CORRUPTION OF THE S-ICD OPERATING STATE OR DEVICE MEMORY DUE TO A SINGLE EVENT UPSET (SEU). SEUS ARE KNOWN TO AFFECT MEMORY IN ELECTRONIC DEVICES. AS PART OF THE ROOT CAUSE INVESTIGATION FOR THIS DEVICE, ENGINEERS REPLICATED A SIMILAR DEVICE BEHAVIOR (VIA SPECIFIC MEMORY CORRUPTION) AND OBSERVED ENERGY OUTPUT SIMILAR TO THE ARRHYTHMIA INDUCTION FUNCTION , CORRELATING WITH DATA FROM THIS EVENT. THIS LED TO THE CONCLUSION THAT MEMORY CORRUPTION DUE TO AN SEU WAS THE MOST PROBABLE ROOT CAUSE FOR THIS EVENT.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS S-ICD PATIENT PASSED AWAY ON (B)(6) 2017. IT WAS REPORTED THAT, EARLY IN THE MORNING OF (B)(6) 2017, THE PATIENT'S MOTHER FOUND HIM ON THE FLOOR, UNRESPONSIVE AND BREATHING ABNORMALLY. A CALL WAS PLACED TO 911 FOR AN AMBULANCE AND CPR WAS STARTED BY THE PATIENT'S MOTHER. UPON ARRIVAL, THE EMS REPORTED THAT THE PATIENT WAS STILL UNRESPONSIVE. CPR WAS CONTINUED AND INTRAVENOUS FLUIDS AND RESUSCITATIVE MEDICATIONS WERE ADMINISTERED. THE PATIENT WAS CONNECTED TO AN AUTOMATED EXTERNAL DEFIBRILLATOR; HOWEVER, A SOLID GREEN BAR WAS OBSERVED ON THE DEFIBRILLATOR MONITOR AND IT DISPLAYED A "NO SHOCK ADVISED" MESSAGE. AS A RESULT, EXTERNAL SHOCK THERAPY WAS NOT DELIVERED. SIMILAR RESULTS WERE OBSERVED WHEN A SECOND EXTERNAL AUTOMATED DEFIBRILLATOR WAS CONNECTED TO THE PATIENT. IN THE ER, IT WAS REPORTED THAT THE PATIENT WAS ASYSTOLIC AND AN ECHOCARDIOGRAM REVEALED CARDIAC STANDSTILL. NO EXTERNAL SHOCKS WERE DELIVERED AND THE PATIENT WAS PRONOUNCED DECEASED IN THE ER. A REQUEST WAS MADE BY THE ATTENDING PHYSICIAN TO INTERROGATE THE PATIENT'S DEVICE POST-MORTEM. ATTEMPTS TO INTERROGATE THE DEVICE REVEALED UNEXPECTED INFORMATION AND ERROR SCREENS APPEARED ON THE PROGRAMMER DURING MULTIPLE INTERROGATION ATTEMPTS. THE PROGRAMMER ALSO HALTED WHEN ATTEMPTING TO SELECT EPISODES. AN ADDITIONAL CONNECTION WAS RE-ESTABLISHED BETWEEN THE DEVICE AND PROGRAMMER AND THE SESSION WAS IMMEDIATELY ENDED TO ENABLE STORAGE OF THE SESSION WITHOUT ERRORS FOR FURTHER ENGINEERING ANALYSIS. PRELIMINARY REVIEW OF THE PROGRAMMER STORED DATA BY BOSTON SCIENTIFIC ENGINEERS INDICATED THAT THIS DEVICE SHOWED SYMPTOMS ASSOCIATED WITH A DEVICE RESET. THE DEVICE AND ELECTRODE WERE SUBSEQUENTLY EXPLANTED AND RETURNED TO BOSTON SCIENTIFIC FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    383582 S-ICD SYSTEM IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND CLONMEL A209 00802526544101

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Death| H| L| R