BEUDAMED
    FDA Adverse Event Injury Summary report: N

    S-ICD SYSTEM

    MDR report key: 7730661 · Received July 30, 2018

    Report

    Report Number
    2124215-2018-13832
    Event Type
    Injury
    Date Received
    July 30, 2018
    Date of Event
    May 7, 2018
    Report Date
    May 7, 2018
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BIOMEDICAL ENGINEERS WERE CALLED TO THE MEDICAL FACILITY FOR ONSITE EQUIPMENT CURRENT TESTING/ASSESSMENT. ELECTRICAL SAFETY TESTING WAS CONDUCTED ON ALL EQUIPMENT. ENGINEERS CONFIRMED THE POLYGRAPH USED IN THE OPERATING ROOM WAS OUT OF CURRENT LEAKAGE SPECIFICATION: THE UNIT WAS REMOVED. THE HEALTH ADMINISTRATION RELEASED THE DEVICE FOR LABORATORY ANALYSIS. ENGINEERING REVIEW OF DATA CONFIRMED 161 SECONDS OF INDUCTION RECORDED IN THE DEVICE LOG. EXTERNAL STRIP ALSO CONFIRMING NOISE WHEN DEVICE WAS ON, WHICH APPEARED TO CORRELATE WITH THE DEVICE PERFORMING AN UNUSUALLY LONG INDUCTION DURATION. THERE WERE NO RESULTING ADVERSE PATIENT EFFECTS REPORTED AFTER THE PROCEDURE DESPITE AN EXTENDED VF DURATION. THE PATIENT WAS DISCHARGED AFTER A ONE DAY ADMISSION. RETURNED PRODUCT ANALYSIS AND AN INVESTIGATION BY BOSTON SCIENTIFIC¿S ENGINEERS, CONFIRMED A ROOT CAUSE CONCLUSION, OF A SINGLE EVENT UPSET (SEU)- INDUCED MEMORY FIRMWARE CORRUPTION; SPECIFICALLY, CORRUPTION IMPACTING THE FUNCTION OF A TIMER INTEGRAL TO MULTIPLE DEVICE FUNCTIONS. A SEU IS A CHANGE OF STATE IN THE DEVICE MEMORY INDUCED BY AN IONIZING PARTICLE; SEUS CAN BE COMPRISED OF A SINGLE-BIT FLIP, MULTIPLE-BIT FLIPS, OR LOGIC ERRORS. IN THIS EVENT, THE SEU-AFFECTED CODE, DISABLED THE DEVICE¿S HOURLY MEMORY INTEGRITY CHECKS AND THUS THE MEMORY CORRUPTION COULD NOT BE DETECTED AND SELF-CORRECTED. THE SEU-AFFECTED FIRMWARE CODE ALSO PREVENTED THE DEVICE FROM COMPLETING A REFERENCE TEMPLATE ACQUISITION AND AUTOMATICALLY TERMINATING A COMMANDED INDUCTION DURING IMPLANT TESTING. FOLLOWING DETAILED MEMORY ANALYSIS AND SIMULATION TESTING WITH A TEST DEVICE, THIS DEVICE, WAS THEN SUBJECTED TO ELECTRICAL AND FUNCTIONAL TESTING. ENGINEERS CONFIRMED THAT THE S-ICD SENSED APPROPRIATELY AND SHOCKED A SIMULATED HIGH RATE ARRHYTHMIA. A DETAILED REVIEW OF THE MANUFACTURING RECORDS ASSOCIATED WITH THIS S-ICD DID NOT REVEAL ANY SIGNALS TO INDICATE A POTENTIAL ISSUE WITH THIS DEVICE AT THE TIME OF MANUFACTURING.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING POST IMPLANT INDUCTION TESTING, FOLLOWING POCKET CLOSURE AND AFTER RUNNING AUTO SETUP, DIFFICULTY WAS EXHIBITED ESTABLISHING TELEMETRY WITH THE SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (SICD), RESULTING IN AN INABILITY TO COLLECT REFERENCE TEMPLATES. THE LOCAL FIELD REPRESENTATIVE STATED THAT THE TELEMETRY ISSUE WAS UNRESOLVED VIA USE OF A TELEMETRY WAND OR THE USE OF A SECOND PROGRAMMER. THE PHYSICIAN ELECTED TO ACQUIRE THE S-ECG REFERENCE AFTER INDUCTION TESTING. VENTRICULAR FIBRILLATION (VF) WAS INDUCED BY 3 SECS OF 50 HZ HOWEVER, THE S-ECG ON THE PROGRAMMER DISAPPEARED WITH ONLY A FLAT LINE VISIBLE AND STRONG NOISE, APPEARED ON THE EXTERNAL DEFIBRILLATOR SCREEN AND ON THE VITAL SIGN MONITOR AND HEART MONITORING EQUIPMENT (POLYGRAPH) SCREEN: NOISE WAS OF HIGH AMPLITUDE AND APPEARED TO DISRUPTED VF DETECTION. THE PHYSICIAN ELECTED TO PERFORM CPR WHILE AN EXTERNAL DEFIBRILLATOR WAS CONNECTED. THE EXTERNAL DEFIBRILLATOR FAILED TO CHARGE AND ANOTHER IDENTICAL UNIT WAS CONNECTED. THE SECOND EXTERNAL DEFIBRILLATOR WAS ALSO UNABLE TO EXECUTE A CHARGING COMMAND, AT WHICH TIME THE PHYSICIAN REQUESTED THE SICD BE TURNED OFF. FOLLOWING DEVICE DEACTIVATION, THE S-ECG ON THE EXTERNAL DEFIBRILLATOR AND ON THE POLYGRAPH, REAPPEARED. VF WAS THEN SUCCESSFULLY CONVERTED VIA EXTERNAL DEFIBRILLATION. NO ADDITIONAL SICD TROUBLESHOOTING WAS PERFORMED. AT THIS POINT, THE PHYSICIAN ELECTED TO REOPEN THE POCKET AND REPLACED THE SICD WHILE PATIENT REMAINED UNDER GENERAL ANESTHESIA. TELEMETRY PROBLEMS PERSISTED WITH THE SECOND SICD AND IT WAS NOT POSSIBLE TO INSERT PATIENT DATA NOR ACQUIRE S-ECG REFERENCE. THEN SUDDENLY AND WITHOUT FURTHER INTERVENTION, ALL TELEMETRY ANOMALIES RESOLVED. ROOT CAUSE WAS NOT IDENTIFIED: THE SECOND SICD REMAINED IMPLANTED AND THE PROCEDURE COMPLETED WITHOUT A SECOND INDUCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    574496 S-ICD SYSTEM LWS GUIDANT CRM CLONMEL IRELAND A219

    Patients

    Seq Age Sex Outcome Treatment
    1 254 MO Required Intervention 3501| A219