BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONFIRM

    MDR report key: 8685450 · Received June 10, 2019

    Report

    Report Number
    2017865-2019-09418
    Event Type
    Malfunction
    Date Received
    June 10, 2019
    Date of Event
    June 3, 2019
    Report Date
    June 10, 2019
    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
    TX, US
    Reporter Occupation
    117

    Narratives

    Additional Manufacturer Narrative · 1

    THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S IMPLANTABLE CARDIAC MONITOR EXHIBITED UNDERSENSING WITH BUNDLE BRANCH PATTERN CHANGE AND MOVEMENT. PROGRAMMING CHANGES WERE MADE. THE PATIENT WAS STABLE THROUGHOUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    478408 CONFIRM IMPLANTABLE CARDIAC MONITOR MXC ST. JUDE MEDICAL, INC.(CRM-SYLMAR) DM3500 S000056570 05415067027320

    Patients

    Seq Age Sex Outcome Treatment
    1