BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EMBLEM S-ICD

    MDR report key: 9673988 · Received February 5, 2020

    Report

    Report Number
    2124215-2020-03151
    Event Type
    Injury
    Date Received
    February 5, 2020
    Date of Event
    December 6, 2018
    Report Date
    February 5, 2020
    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
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED DEVICE WAS THOROUGHLY INSPECTED AND ANALYZED. VISUAL INSPECTION IDENTIFIED NO ANOMALIES. THE DEVICE WAS ABLE TO BE INTERROGATED AND A MEMORY DOWNLOAD WAS PERFORMED SUCCESSFULLY. THE DEVICE WAS THEN EXPOSED TO SIMULATED HEART LOAD CONDITIONS, AND THE DEFIBRILLATION AND SENSING FUNCTIONS WERE TESTED. THE DEVICE OPERATED APPROPRIATELY, ACCORDING TO ITS PERFORMANCE SPECIFICATIONS WITH NO OUT OF RANGE MEASUREMENTS OR INTERRUPTIONS IN THERAPY OUTPUT. ANALYSIS DID NOT IDENTIFY ANY DEVICE CHARACTERISTICS THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED CLINICAL OBSERVATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THIS SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) AND ELECTRODE DISPLAYED NOISE AND OVERSENSING RESULTING IN THE STORAGE OF AN UNTREATED EPISODE. IT WAS REPORTED THAT THE PATIENT WAS WORKING HARD AND FELT PAIN IN THEIR STERNUM. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) REVIEWED THE EPISODE DATA AND CONFIRMED THE NOISE APPEARED TO BE MYOPOTENTIAL. IT ALSO APPEARED THAT THE INTRINSIC R-WAVE AMPLITUDES HAVE DECREASED. TS RECOMMENDED PERFORMING A THOROUGH FOLLOW-UP IN AN ATTEMPT TO REPRODUCE THE NOISE AND SIGNAL CHANGES, INCLUDING CHANGES IN BODY POSTURES AND ARM MANEUVERS. TS ALSO RECOMMENDED OBTAINING A FULL CHEST PA AND LL X-RAY TO EVALUATE THE SYSTEM PLACEMENT COMPARED TO THE INITIAL IMPLANT. ADDITIONAL INFORMATION WAS RECEIVED THAT THIS DEVICE DELIVERED INAPPROPRIATE SHOCKS. THE DEVICE DATA WAS SENT IN FOR REVIEW TO BOSTON SCIENTIFIC TECHNICAL SERVICES (TS). TS REVIEWED THE DATA SENT IN AND CONFIRMED THERE WERE MULTIPLE EPISODES OF INAPPROPRIATE THERAPY DELIVERED IN ALTERNATE VECTOR DUE TO NON-PHYSIOLOGIC SIGNALS. THE RECENT EPISODES ALSO DISPLAYED BASELINE SHIFTING AND HIGH AMPLITUDE NOISE. THE SMARTPASS FEATURE WAS DISABLED ON (B)(6) 2019 DUE TO LOW R-WAVE AMPLITUDES. SIMILAR NOISE WAS OBSERVED IN SOME UNTREATED EPISODES FROM (B)(6) 2019 IN PRIMARY VECTOR. THE NOISE APPEARED TO BE RELATED TO SOMETHING BLOCKING THE SENSING IN B-NODE TO CAN PATHWAY. THE IMPEDANCE MEASUREMENTS WERE WITHIN EXPECTED LIMITS. TS DISCUSSED PROGRAMMING TO SECONDARY VECTOR, HOWEVER THERE WERE LOW AMPLITUDE R-WAVES IN THIS VECTOR AND SMARTPASS MAY BECOME DISABLED WHICH COULD ALLOW T-WAVE OVERSENSING TO OCCUR. TS ALSO DISCUSSED INVASIVE OPTIONS. THE RECOMMENDATION WAS TO FURTHER INVESTIGATE THE ISSUE BY PERFORMING VIGOROUS TESTING IN AN ATTEMPT TO RECREATE THE NOISE. A HIGH RESOLUTION X-RAY WAS ALSO RECOMMENDED TO VERIFY SYSTEM LOCATION AND THE ELECTRODE CONNECTION. ADDITIONAL INFORMATION FROM THE LOCAL FIELD REPRESENTATIVE WAS RECEIVED, WHICH CONFIRMED THE PATIENT PRESENTED AND EXTENSIVE INVESTIGATION WAS PERFORMED. IT WAS IDENTIFIED THAT ALL OF THE INAPPROPRIATE SHOCKS WERE DELIVERED WHEN THE PATIENT WAS AT REST (SITTING IN FRONT OF THE TV OR DRIVING A CAR). AFTER A HIGH RESOLUTION X-RAY OF THE DEVICE HEADER, IT WAS CONCLUDED THAT THE LEAD WAS PROPERLY INSERTED. ARTIFACTS WERE NOT ABLE TO BE RECREATED WITH MANIPULATION OVER AND AROUND THE HEADER NOR WITH EXTENSIVE TWISTING OF THE PATIENT. THERE WERE LITTLE, BUT INSIGNIFICANT MYOPOTENTIALS IN SECONDARY VECTOR. A DEVICE OPTIMIZATION WAS PERFORMED AND THE DEVICE CHOSE ALTERNATE VECTOR WITH 2X GAIN. PRIMARY AND SECONDARY VECTOR DISPLAYED A DOMINATING T-WAVE. IT WAS CONCLUDED THAT THE CONTRIBUTING ISSUE TO THE INAPPROPRIATE SHOCKS WERE RELATED TO LOW R-WAVES AND LEAD PLACEMENT. THE PATIENT REQUESTED THAT THE DEVICE THERAPY REMAIN DISABLED. A FOLLOW-UP APPOINTMENT WAS SCHEDULED IN THE FUTURE TO DISCUSS THE NEXT STEPS. ADDITIONAL INFORMATION WAS RECEIVED THAT THIS DEVICE AND ELECTRODE WERE EXPLANTED. THE PHYSICIAN TOOK TWO PHOTOS OF THE LEAD PRIOR TO DISCONNECTING IT FROM THE DEVICE. THE PRODUCTS WERE SENT TO OUR POST MARKET QUALITY ASSURANCE LABORATORY FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    133774 EMBLEM S-ICD IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) LWS BOSTON SCIENTIFIC CORPORATION A209 218703 00802526544101

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention