BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EMBLEM S-ICD

    MDR report key: 8268454 · Received January 22, 2019

    Report

    Report Number
    2124215-2018-63397
    Event Type
    Injury
    Date Received
    January 22, 2019
    Date of Event
    November 5, 2018
    Report Date
    August 28, 2019
    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
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    UPON RECEIPT AT BSC'S POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE DEVICE WAS PERFORMED. A REVIEW OF THE DEVICE MEMORY NOTED THAT 276 MISSION CRITICAL REGISTER (MCR) ERRORS WERE RECORDED ON (B)(6) 2018, INDICATING THAT CERTAIN PROTECTED AREAS OF MEMORY WITHIN THE DIGITAL INTEGRATED CIRCUIT (IC) COMPONENT HAD CHANGED VALUES UNEXPECTEDLY AND WERE CORRECTED BY THE DEVICE. NO FURTHER MCR ERRORS WERE RECORDED. THE BATTERY VOLTAGE AND POWER CONSUMPTION DIAGNOSTIC DATA WERE WITHIN NORMAL LIMITS . THE DEVICE WAS THEN EXPOSED TO SIMULATED HEART LOAD CONDITIONS, AND THE DEFIBRILLATION, PACING, AND SENSING FUNCTIONS WERE TESTED. THE RETURNED DEVICE OPERATED APPROPRIATELY WITH NO INTERRUPTIONS IN THERAPY OUTPUT AT THE RETURNED PROGRAMMED SETTINGS. A SERIES OF ELECTRICAL TESTS WAS ALSO PERFORMED, AND AGAIN, NORMAL DEVICE FUNCTION WAS OBSERVED. ADDITIONAL TESTING OF THE DEVICE AND THE INDIVIDUAL DIGITAL IC COMPONENT WAS ABLE TO RECREATE MCR ERRORS. DETAILED TESTING DETERMINED THAT THE SOURCE OF THE MCR ERRORS WAS AN INTERMITTENT MALFUNCTION WITHIN THE DIGITAL IC COMPONENT. PLEASE NOTE THAT LABORATORY ANALYSIS DID NOT IDENTIFY ANY EVIDENCE THAT THERAPY WAS UNAVAILABLE TO THE PATIENT WHILE IMPLANTED. PLEASE NOTE THAT THE PREVIOUS 3500A REPORT INCORRECTLY STATED THAT THE DEVICE EXHIBITED EXCESSIVE CURRENT LEAKAGE. THIS DID NOT OCCUR.

    Additional Manufacturer Narrative · 0

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A REVIEW OF THE DEVICE MEMORY NOTED THAT 276 MISSION CRITICAL REGISTER (MCR) ERRORS WERE RECORDED ON (B)(6) 2018. NO FURTHER MCR ERRORS WERE RECORDED. THE DEVICE WAS THEN EXPOSED TO SIMULATED HEART LOAD CONDITIONS AND THE DEFIBRILLATION, PACING AND SENSING FUNCTIONS WERE TESTED. IMPEDANCE TESTING WAS COMPLETED AND ALL MEASUREMENTS WERE WITHIN NORMAL LIMITS. THE DEVICE OPERATED APPROPRIATELY WITH NO INTERRUPTIONS IN THERAPY OUTPUT AT THE RETURNED PROGRAMMED SETTINGS. A SERIES OF ELECTRICAL TESTS WAS ALSO PERFORMED AND AGAIN, NORMAL DEVICE FUNCTION WAS OBSERVED. THE ROUTINE PRODUCT TESTING PERFORMED RESTORES THE MANUFACTURING FIRMWARE IN THE DEVICE MEMORY. THE FIRMWARE USED IN THE FIELD WAS DOWNLOADED ONTO THE DEVICE. AFTERWARDS, THE DEVICE RECORDED AN ADDITIONAL 4 MCR ERRORS. THE DEVICE CASING WAS REMOVED, AND AN EXTERNAL POWER SOURCE WAS APPLIED TO THE HYBRID AND THE BOARD POWERED UP NORMALLY. THE FIRMWARE WAS SUCCESSFULLY DOWNLOADED BUT MEMORY REVIEW NOTED AN INVALID PATIENT LOG FORMAT. A MEMORY DUMP WAS PERFORMED AND CONFIRMED THAT THE DIGITAL IC UNDERWENT MCR ERRORS DURING THE FIRMWARE DOWNLOAD. EXTENSIVE DETAILED ANALYSIS TESTING FOUND THAT DIGITAL IC WHICH HAD EXCESSIVE CURRENT LEAKAGE IN ONE OF THE POWER SUPPLIES WITHIN THE IC.

    Description of Event or Problem · 0

    THIS REPORT IS BEING FILED TO CORRECT THE ANALYSIS FINDINGS.

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS BEEN RECEIVED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON COMPLETION OF ANALYSIS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THIS DEVICE RECORDED A CODE WB INDICATIVE THAT THE DEVICE WAS TRYING TO SELF-RESET ITSELF IN AN ATTEMPT TO SELF-CORRECT BUT WAS UNABLE TO. A REQUEST WAS MADE TO HAVE DATA FROM THIS DEVICE ANALYZED. DATA ANALYSIS SHOWED MEMORY CORRUPTION. DEVICE REPLACEMENT WAS RECOMMENDED. THE DEVICE WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    59943 EMBLEM S-ICD IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) LWS BOSTON SCIENTIFIC CORPORATION A209 112099 00802526544101

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Hospitalization| L| R