BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PACEART OPTIMA

    MDR report key: 8010896 · Received October 26, 2018

    Report

    Report Number
    2182208-2018-01965
    Event Type
    Malfunction
    Date Received
    October 26, 2018
    Date of Event
    September 27, 2018
    Report Date
    October 26, 2018
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    KRE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 WHEN VIEWING TASKS IN THE PATIENT MANAGEMENT DATABASE APPLICATION THE VIEW DOESN'T CORRELATE WITH THE PATIENT THAT WAS SELECTED. THE ISSUE WAS ESCALATED AND AN UPDATE TO FIX THE ISSUE WILL BE PROVIDED. THE APPLICATION REMAINS IN USE. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    850384 PACEART OPTIMA ANALYZER, PACEMAKER GENERATOR FUNCTION, INDIRECT KRE MEDTRONIC, INC. PAOPT18SUP

    Patients

    Seq Age Sex Outcome Treatment
    1