BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMBLEM MRI S-ICD

    MDR report key: 14802572 · Received June 24, 2022

    Report

    Report Number
    2124215-2022-22726
    Event Type
    Malfunction
    Date Received
    June 24, 2022
    Date of Event
    May 13, 2022
    Report Date
    June 24, 2022
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LWS
    UDI-DI
    00802526584404
    PMA / PMN Number
    P110042/S058
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CAPA-(B)(4) EMBLEM S-ICD TRANSIENT MEMORY CORRUPTION, SINGLE EVENT UPSET (SEU).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, AFTER A SOFTWARE UPGRADE, THERE WAS A MESSAGE ON THE PROGRAMMER INDICATING AN APPLICATION ERROR. THIS OCCURRED AGAIN WITH A DIFFERENT PROGRAMMER. THE MESSAGE OCCURS WHEN ATTEMPTING TO VIEW STORED EPISODES. A REVIEW OF DEVICE DATA BY TECHNICAL SERVICES CONFIRMED A BIT FLIPPED IN THE PATIENT DATA AREA OF THE DEVICE MEMORY. THIS HAS NO IMPACT ON THERAPY. THERE WERE NO ADVERSE PATIENT EFFECTS. THE DEVICE REMAINS IMPLANTED. THIS EVENT IS PART OF CAPA-(B)(4) EMBLEM S-ICD TRANSIENT MEMORY CORRUPTION, SINGLE EVENT UPSET (SEU).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1055737 EMBLEM MRI S-ICD IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) LWS BOSTON SCIENTIFIC CORPORATION A219 129432 00802526584404

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male