BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMBLEM¿ MRI S-ICD

    MDR report key: 15876639 · Received November 29, 2022

    Report

    Report Number
    15876639
    Event Type
    Malfunction
    Date Received
    November 29, 2022
    Date of Event
    October 18, 2022
    Report Date
    November 14, 2022
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    NG TUBE 6.5 FR MEDELA NG FOUND TO BE CRACKED AND LEAKING AT THE HUB; REQUIRED REPLACEMENT WHICH IS STRESSFUL FOR INFANT. LOT # 220565.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1672139 EMBLEM¿ MRI S-ICD IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) LWS BOSTON SCIENTIFIC CORPORATION A219 220565

    Patients

    Seq Age Sex Outcome Treatment
    1 30 DA Male