BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PACEART OPTIMA SYSTEM SOFTWARE

    MDR report key: 11636507 · Received April 8, 2021

    Report

    Report Number
    2182208-2021-01393
    Event Type
    Malfunction
    Date Received
    April 8, 2021
    Date of Event
    March 9, 2021
    Report Date
    April 8, 2021
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    KRE
    PMA / PMN Number
    K110693
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT MANAGEMENT DATABASE APPLICATION DISPLAYED TACHYARRHYTHMIA THERAPIES AS BEING "ON" WHEN THE COMPETITOR'S PROGRAMMER DISPLAYED TACHYARRHYTHMIA THERAPIES AS BEING "OFF". ATTEMPTED TO HAVE CLINICIAN SAVE THE DATA FILE SAVED FOR THE ENCOUNTER BACK TO THE UNIVERSAL SERIAL BUS (USB) AND READ IT ON THE PROGRAMMER TO VERIFY THE SETTINGS ARE AS DESCRIBED. THE CLINICIAN DIDN'T KNOW HOW TO READ BACK THE FILE ON TO THE PROGRAMMER. THE CLINICIAN WILL CALL THE COMPETITOR REPRESENTATIVE FOR ASSISTANCE WITH THE FILE. THE APPLICATION REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    532902 PACEART OPTIMA SYSTEM SOFTWARE ANALYZER, PACEMAKER GENERATOR FUNCTION, INDIRECT KRE MEDTRONIC, INC. POS12D18

    Patients

    Seq Age Sex Outcome Treatment
    1