BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EMBLEM S-ICD

    MDR report key: 11356538 · Received February 20, 2021

    Report

    Report Number
    2124215-2021-03542
    Event Type
    Injury
    Date Received
    February 20, 2021
    Date of Event
    January 24, 2021
    Report Date
    July 8, 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
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING FILED TO CORRECT THE INITIAL REPORTER FIRST AND LAST NAME.

    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 (B)(6) 2020. THIS PARTICULAR DEVICE IS INCLUDED IN THE EMBLEM S-ICD ACCELERATED DEPLETION ADVISORY POPULATION.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING FILED TO CORRECT THE INITIAL REPORTER FIRST AND LAST NAME AND THE IMPLANT DATE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PREMATURE BATTERY DEPLETION WAS ALLEGED INVOLVING THIS DEVICE. THE DEVICE BATTERY WAS AT 7% REMAINING AND A DEVICE CHANGE OUT WAS SCHEDULED, BUT HAD TO BE CANCELLED DUE TO LOGISTICAL ISSUES AT THE CENTER. A REQUEST FOR DEVICE DATA REVIEW WAS NEEDED TO SEE HOW MUCH TIME WAS LEFT WHEN IT COMES TO THE DEVICE BATTERY FOR RE-SCHEDULING THE CHANGEOUT. A REVIEW OF THE DEVICE DATA BY TECHNICAL SERVICES (TS) CONFIRMED THAT THE DEVICE WAS MALFUNCTION AND THE BATTERY CONSUMPTION HAD INCREASED ABNORMALLY. THE DEVICE SHOULD HAVE ENOUGH CAPACITY TO SUPPORT THERAPY FOR SIXTY TWO DAYS. THE REPLACEMENT INTERVAL RUNS UNTIL (B)(6) 2011. AT THIS TIME THE DEVICE REMAINS IMPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PREMATURE BATTERY DEPLETION WAS ALLEGED INVOLVING THIS DEVICE. THE DEVICE BATTERY WAS AT 7% REMAINING AND A DEVICE CHANGE OUT WAS SCHEDULED, BUT HAD TO BE CANCELLED DUE TO LOGISTICAL ISSUES AT THE CENTER. A REQUEST FOR DEVICE DATA REVIEW WAS NEEDED TO SEE HOW MUCH TIME WAS LEFT WHEN IT COMES TO THE DEVICE BATTERY FOR RE-SCHEDULING THE CHANGEOUT. A REVIEW OF THE DEVICE DATA BY TECHNICAL SERVICES (TS) CONFIRMED THAT THE DEVICE WAS MALFUNCTION AND THE BATTERY CONSUMPTION HAD INCREASED ABNORMALLY. THE DEVICE SHOULD HAVE ENOUGH CAPACITY TO SUPPORT THERAPY FOR SIXTY TWO DAYS. THE REPLACEMENT INTERVAL RUNS UNTIL (B)(6) 2011. THE DEVICE WAS EXPLANTED AND RETURNED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PREMATURE BATTERY DEPLETION WAS ALLEGED INVOLVING THIS DEVICE. THE DEVICE BATTERY WAS AT 7% REMAINING AND A DEVICE CHANGE OUT WAS SCHEDULED, BUT HAD TO BE CANCELLED DUE TO LOGISTICAL ISSUES AT THE CENTER. A REQUEST FOR DEVICE DATA REVIEW WAS NEEDED TO SEE HOW MUCH TIME WAS LEFT WHEN IT COMES TO THE DEVICE BATTERY FOR RE-SCHEDULING THE CHANGEOUT. A REVIEW OF THE DEVICE DATA BY TECHNICAL SERVICES (TS) CONFIRMED THAT THE DEVICE WAS MALFUNCTION AND THE BATTERY CONSUMPTION HAD INCREASED ABNORMALLY. THE DEVICE SHOULD HAVE ENOUGH CAPACITY TO SUPPORT THERAPY FOR SIXTY TWO DAYS. THE REPLACEMENT INTERVAL RUNS UNTIL (B)(6) 2011. THE DEVICE WAS EXPLANTED AND WILL BE RETURNED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PREMATURE BATTERY DEPLETION WAS ALLEGED INVOLVING THIS DEVICE. THE DEVICE BATTERY WAS AT 7% REMAINING AND A DEVICE CHANGE OUT WAS SCHEDULED, BUT HAD TO BE CANCELLED DUE TO LOGISTICAL ISSUES AT THE CENTER. A REQUEST FOR DEVICE DATA REVIEW WAS NEEDED TO SEE HOW MUCH TIME WAS LEFT WHEN IT COMES TO THE DEVICE BATTERY FOR RE-SCHEDULING THE CHANGEOUT. A REVIEW OF THE DEVICE DATA BY TECHNICAL SERVICES (TS) CONFIRMED THAT THE DEVICE WAS MALFUNCTION AND THE BATTERY CONSUMPTION HAD INCREASED ABNORMALLY. THE DEVICE SHOULD HAVE ENOUGH CAPACITY TO SUPPORT THERAPY FOR SIXTY TWO DAYS. THE REPLACEMENT INTERVAL RUNS UNTIL APRIL 2011. AT THIS TIME THE DEVICE REMAINS IMPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252821 EMBLEM S-ICD IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) LWS BOSTON SCIENTIFIC CORPORATION A209 116419 00802526544101

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R