BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONFIRM

    MDR report key: 9193081 · Received October 15, 2019

    Report

    Report Number
    2017865-2019-15067
    Event Type
    Malfunction
    Date Received
    October 15, 2019
    Date of Event
    October 1, 2019
    Report Date
    October 16, 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
    NC, US
    Reporter Occupation
    NURSE

    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 PRESENTED REMOTELY VIA MERLIN.NET WITH EPISODES OF CARDIAC PAUSES FROM THE IMPLANTABLE CARDIAC MONITOR. IT WAS DETERMINED THAT THE PAUSES WERE FALSE AND WERE CAUSED BY R WAVE UNDERSENSING. PROGRAMMING CHANGES WERE RECOMMENDED. NO PATIENT SYMPTOMS WERE REPORTED.

    Description of Event or Problem · 1

    NEW INFORMATION RECEIVED STATED THAT THE RECOMMENDED PROGRAMMING CHANGES WERE COMPLETED ON OCT. 1ST, 2019.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    986718 CONFIRM IMPLANTABLE CARDIAC MONITOR MXC ST. JUDE MEDICAL, INC.(CRM-SYLMAR) DM3500 P000078906 05415067027320

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR