BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMBLEM S-ICD

    MDR report key: 17056570 · Received June 2, 2023

    Report

    Report Number
    2124215-2023-28269
    Event Type
    Malfunction
    Date Received
    June 2, 2023
    Date of Event
    January 1, 2016
    Report Date
    June 2, 2023
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE SOURCE LITERATURE REPORTED THAT FROM 2016 TO 2020, 628 PATIENTS ACROSS 66 ITALIAN HEALTHCARE FACILITIES WERE IMPLANTED WITH EMBLEM SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEMS. OVER A MEDIAN OF 43 MONTHS OF FOLLOW-UP APPOINTMENTS, 10% OF PATIENTS RECEIVED INAPPROPRIATE SHOCK(S), THE MAJORITY OF WHICH WERE MANAGED WITHOUT SURGICAL INTERVENTION REQUIRED. THE SPECIFIC CAUSE OF THE SHOCK(S) WAS NOT PROVIDED. PREMATURE BATTERY DEPLETION WAS NOTED IN 8% OF PATIENT WHICH WAS RESOLVED BY SURGICAL REPLACEMENT OF THE DEVICE. ANOTHER 4% OF PATIENTS EXPERIENCED UNSPECIFIED DEVICE MALFUNCTIONS. PLEASE NOTE THAT THIS STUDY IS STILL IN THE DRAFT STAGE AND NO FURTHER INFORMATION WAS PROVIDED REGARDING THE SPECIFIC SERIAL NUMBERS OF THE DEVICES NOR THE HEALTHCARE FACILITIES INVOLVED. NO SERIOUS ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    257423 EMBLEM S-ICD IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) LWS BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown