BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EMBLEM S-ICD

    MDR report key: 14885390 · Received July 1, 2022

    Report

    Report Number
    2124215-2022-23822
    Event Type
    Injury
    Date Received
    July 1, 2022
    Date of Event
    June 22, 2022
    Report Date
    September 9, 2022
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LWS
    UDI-DI
    00802526544101
    PMA / PMN Number
    P110042/S043
    Removal / Correction Number
    Z-0935-2021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    003

    Narratives

    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 THIS SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) DISPLAYED A BD (BATTERY DEPLETION) ALERT. TECHNICAL SERVICES (TS) ANALYZED BATTERY DIAGNOSTIC DATA WHICH INDICATED THE POWER CONSUMPTION OF THIS DEVICE HAS BEEN STEADILY INCREASING. IT WAS ADVISED TO CONTINUE TO MONITOR. THE PATIENT'S FOLLOWING PHYSICIAN WAS NOTIFIED ACCORDINGLY. NO ADVERSE PATIENT EFFECTS WERE REPORTED. CURRENTLY, THIS DEVICE REMAINS IN SERVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) DISPLAYED A BD (BATTERY DEPLETION) ALERT. TECHNICAL SERVICES (TS) ANALYZED BATTERY DIAGNOSTIC DATA WHICH INDICATED THE POWER CONSUMPTION OF THIS DEVICE HAS BEEN STEADILY INCREASING. IT WAS ADVISED TO CONTINUE TO MONITOR. THE PATIENT'S FOLLOWING PHYSICIAN WAS NOTIFIED ACCORDINGLY. NO ADVERSE PATIENT EFFECTS WERE REPORTED. CURRENTLY, THIS DEVICE REMAINS IN SERVICE. ACCORDING TO ADDITIONAL INFORMATION RECEIVED, THIS DEVICE WAS EXPLANTED AND REPLACED WITH A NEW S-ICD. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) DISPLAYED A BD (BATTERY DEPLETION) ALERT. TECHNICAL SERVICES (TS) ANALYZED BATTERY DIAGNOSTIC DATA WHICH INDICATED THE POWER CONSUMPTION OF THIS DEVICE HAS BEEN STEADILY INCREASING. IT WAS ADVISED TO CONTINUE TO MONITOR. THE PATIENT'S FOLLOWING PHYSICIAN WAS NOTIFIED ACCORDINGLY. NO ADVERSE PATIENT EFFECTS WERE REPORTED. CURRENTLY, THIS DEVICE REMAINS IN SERVICE. ACCORDING TO ADDITIONAL INFORMATION RECEIVED, THIS DEVICE WAS EXPLANTED AND REPLACED WITH A NEW S-ICD. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1143140 EMBLEM S-ICD SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) LWS BOSTON SCIENTIFIC CORPORATION A209 115708 00802526544101

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Male Hospitalization| R