BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONFIRM

    MDR report key: 10268566 · Received July 13, 2020

    Report

    Report Number
    2938836-2020-07385
    Event Type
    Malfunction
    Date Received
    July 13, 2020
    Date of Event
    July 8, 2020
    Report Date
    July 13, 2020
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
    Product Code
    MXC
    UDI-DI
    05415067027320
    PMA / PMN Number
    K163407
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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 IMPLANTABLE CARDIAC MONITOR EXHIBITED BOTH OVERSENSING OF T WAVES AND UNDER SENSING IF R WAVES REPORTING ERRONEOUS PAUSE EVENTS. THE PATIENT WAS BROUGHT INTO THE OFFICE AND REPROGRAMMING WAS COMPLETED. SOME R WAVES COULD NOT BE SENSED AT MAX SENSITIVITY SO THE DECISION WAS MADE BY THE PHYSICIAN TO TURN OFF PAUSE NOTIFICATIONS. THE PATIENT IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    729986 CONFIRM IMPLANTABLE CARDIAC MONITOR MXC ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) DM3500 P000097606 05415067027320

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR