BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EMBLEM S-ICD

    MDR report key: 14023616 · Received April 6, 2022

    Report

    Report Number
    2124215-2022-06886
    Event Type
    Injury
    Date Received
    April 6, 2022
    Date of Event
    March 3, 2022
    Report Date
    May 21, 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
    SP
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    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 THE BATTERY OF THIS SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) WAS SUSPECTED TO BE PREMATURELY DEPLETING. REVIEW OF THE DEVICE DATA CONFIRMED THE POWER CONSUMPTION IS INCREASING IN A GRADUAL FASHION, DEVICE REPLACEMENT WAS RECOMMENDED. AT THIS TIME NO INTERVENTION HAS BEEN PERFORMED AND THE S-ICD REMAINS IMPLANTED AND IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS EVENT WILL BE UPDATED SHOULD A REVISION PROCEDURE BE PERFORMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BATTERY OF THIS SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) WAS SUSPECTED TO BE PREMATURELY DEPLETING. REVIEW OF THE DEVICE DATA CONFIRMED THE POWER CONSUMPTION IS INCREASING IN A GRADUAL FASHION, DEVICE REPLACEMENT WAS RECOMMENDED. AT THIS TIME NO INTERVENTION HAS BEEN PERFORMED AND THE S-ICD REMAINS IMPLANTED AND IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION PROVIDED FROM THE FIELD INDICATED SURGICAL INTERVENTION WAS PERFORMED AND THE S-ICD WAS EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BATTERY OF THIS SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) WAS SUSPECTED TO BE PREMATURELY DEPLETING. REVIEW OF THE DEVICE DATA CONFIRMED THE POWER CONSUMPTION IS INCREASING IN A GRADUAL FASHION, DEVICE REPLACEMENT WAS RECOMMENDED. AT THIS TIME NO INTERVENTION HAS BEEN PERFORMED AND THE S-ICD REMAINS IMPLANTED AND IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION PROVIDED FROM THE FIELD INDICATED SURGICAL INTERVENTION WAS PERFORMED AND THE S-ICD WAS EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THE S-ICD HAS BEEN RETURNED BACK FROM THE FIELD FOR ANALYSIS, THIS EVENT WILL BE UPDATED UPON COMPLETION OF ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2402871 EMBLEM S-ICD IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) LWS BOSTON SCIENTIFIC CORPORATION A209 115282 00802526544101

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization| R