BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONFIRM

    MDR report key: 16661590 · Received April 3, 2023

    Report

    Report Number
    2017865-2023-16473
    Event Type
    Malfunction
    Date Received
    April 3, 2023
    Date of Event
    March 23, 2023
    Report Date
    April 3, 2023
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
    Product Code
    MXC
    UDI-DI
    05415067027320
    PMA / PMN Number
    K163407
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: SECTION E1 - THE REPORTER FIRST/GIVEN NAME SHOULD BE "JOO-YEON" INSTEAD OF "KIM", WHILE THE REPORTER LAST NAME SHOULD BE "KIM" INSTEAD OF "JOO-YEON".

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT PRESENTED REMOTELY VIA MERLIN.NET. REVIEW OF TRANSMISSION REVEALED THAT THE IMPLANTABLE CARDIAC MONITOR (ICM) WAS EXPERIENCING VENTRICULAR UNDER-SENSING. PROGRAMMING CHANGES WERE MADE. THE PATIENT'S CONDITION WAS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1115944 CONFIRM IMPLANTABLE CARDIAC MONITOR MXC ST. JUDE MEDICAL, INC.(CRM-SYLMAR) DM3500 P000154576 05415067027320

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown