BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EMBLEM S-ICD

    MDR report key: 10638752 · Received October 6, 2020

    Report

    Report Number
    2124215-2020-18520
    Event Type
    Injury
    Date Received
    October 6, 2020
    Date of Event
    March 1, 2019
    Report Date
    April 7, 2021
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LWS
    UDI-DI
    00802526544101
    PMA / PMN Number
    P110042/S043
    Removal / Correction Number
    92400926-FA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT CODE 3191 IS BEING USED TO CAPTURE THE ADDITIONAL INTERVENTION REQUIRED.

    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 AN ADVISORY COMMUNICATION IN AUGUST 2019 REGARDING A SUBSET OF EMBLEM DEVICES THAT HAS AN ELEVATED POTENTIAL OF EXHIBITING THIS BEHAVIOR; THE POPULATION OF DEVICES THAT MAY BE IMPACTED WAS EXPANDED IN DECEMBER 2020. 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 DEVICE SHOWED A BATTERY OF 67% REMAINING IN MARCH 2019, 52% BATTERY REMAINING IN FEBRUARY 2020, AND 16% REMAINING IN SEPTEMBER 2020. PREMATURE BATTERY DEPLETION AS ALLEGED. ENGINEERING ANALYSIS CONFIRMED AN INCREASE IN BATTERY CONSUMPTION AND CONFIRMED THE DEVICE WAS AFFECTED BY PREMATURE BATTERY DEPLETION. THE DEVICE WAS SUBSEQUENTLY EXPLANTED AND WILL BE RETURNED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS DEVICE SHOWED A BATTERY OF 67% REMAINING IN MARCH 2019, 52% BATTERY REMAINING IN FEBRUARY 2020, AND 16% REMAINING IN SEPTEMBER 2020. PREMATURE BATTERY DEPLETION AS ALLEGED. ENGINEERING ANALYSIS CONFIRMED AN INCREASE IN BATTERY CONSUMPTION AND CONFIRMED THE DEVICE WAS AFFECTED BY PREMATURE BATTERY DEPLETION. THE DEVICE WAS SUBSEQUENTLY EXPLANTED AND RETURNED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THIS DEVICE SHOWED A BATTERY OF 67% REMAINING IN (B)(6) 2019, 52% BATTERY REMAINING IN (B)(6) 2020, AND 16% REMAINING IN (B)(6) 2020. PREMATURE BATTERY DEPLETION AS ALLEGED. ENGINEERING ANALYSIS CONFIRMED AN INCREASE IN BATTERY CONSUMPTION AND CONFIRMED THE DEVICE WAS AFFECTED BY PREMATURE BATTERY DEPLETION. THE DEVICE SHOULD BE EXPLANTED AND REPLACED. THIS DEVICE REMAIN IMPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1099440 EMBLEM S-ICD IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) LWS BOSTON SCIENTIFIC CORPORATION A209 107587 00802526544101

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R