BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EMBLEM MRI S-ICD

    MDR report key: 17584073 · Received August 21, 2023

    Report

    Report Number
    2124215-2023-44770
    Event Type
    Injury
    Date Received
    August 21, 2023
    Date of Event
    August 1, 2023
    Report Date
    January 18, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LWS
    PMA / PMN Number
    P110042/S058
    Removal / Correction Number
    Z-0936-2021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AT THIS TIME, THE PRODUCT HAS NOT BEEN RETURNED. IF THE PRODUCT IS RETURNED, ANALYSIS WILL BE PERFORMED, AND THIS REPORT WILL BE UPDATED AT THAT TIME.

    Additional Manufacturer Narrative · 0

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, THIS S-ICD WAS THOROUGHLY INSPECTED AND ANALYZED. A HIGH CURRENT DRAIN WAS DETECTED, BUT THE BATTERY STILL SUPPORTED FULL DEVICE FUNCTION. DETAILED ANALYSIS CONFIRMED THE IDENTIFIED HIGH CURRENT DRAIN WAS A RESULT OF A COMPROMISED CAPACITOR. THIS RESULTED IN THE OBSERVED PREMATURE BATTERY DEPLETION. IT WAS DETERMINED THAT THE CAPACITOR WAS COMPROMISED DUE TO THE PRESENCE OF EXCESS HYDROGEN IN THE DEVICE CASE. BOSTON SCIENTIFIC ISSUED A FIELD SAFETY NOTICE REGARDING A SUBSET OF EMBLEM DEVICES THAT HAVE A POTENTIAL OF EXHIBITING THIS BEHAVIOR. THIS PARTICULAR DEVICE IS INCLUDED IN THE EMBLEM S-ICD ACCELERATED DEPLETION ADVISORY POPULATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BATTERY OF THIS SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) WAS SUSPECTED TO BE DEPLETING PREMATURELY AS A BATTERY DEPLETION (BD) ALERT WAS DISPLAYED ON THE MONITORING SYSTEM. A REQUEST WAS MADE TO HAVE DATA FROM THIS DEVICE ANALYZED. DATA ANALYSIS CONFIRMED THE BATTERY APPEARED TO BE DEPLETING MORE QUICKLY THAN EXPECTED AND A SAFE REPLACEMENT WINDOW OF 90 DAYS WAS RECOMMENDED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION PROVIDED FROM THE FIELD INDICATED SURGICAL INTERVENTION WAS LATER PERFORMED AND THIS DEVICE WAS EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THE DEVICE IS EXPECTED TO BE RETURNED FOR ANALYSIS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BATTERY OF THIS SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) WAS SUSPECTED TO BE DEPLETING PREMATURELY AS A BATTERY DEPLETION (BD) ALERT WAS DISPLAYED ON THE MONITORING SYSTEM. A REQUEST WAS MADE TO HAVE DATA FROM THIS DEVICE ANALYZED. DATA ANALYSIS CONFIRMED THE BATTERY APPEARED TO BE DEPLETING MORE QUICKLY THAN EXPECTED AND A SAFE REPLACEMENT WINDOW OF 90 DAYS WAS RECOMMENDED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE DEVICE REMAINS IN SERVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BATTERY OF THIS SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) WAS SUSPECTED TO BE DEPLETING PREMATURELY AS A BATTERY DEPLETION (BD) ALERT WAS DISPLAYED ON THE MONITORING SYSTEM. A REQUEST WAS MADE TO HAVE DATA FROM THIS DEVICE ANALYZED. DATA ANALYSIS CONFIRMED THE BATTERY APPEARED TO BE DEPLETING MORE QUICKLY THAN EXPECTED AND A SAFE REPLACEMENT WINDOW OF 90 DAYS WAS RECOMMENDED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION PROVIDED FROM THE FIELD INDICATED SURGICAL INTERVENTION WAS LATER PERFORMED AND THIS DEVICE WAS EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THE DEVICE WAS RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1896400 EMBLEM MRI S-ICD SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) LWS BOSTON SCIENTIFIC CORPORATION A219 204918

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| H