BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PACEART OPTIMA

    MDR report key: 7967498 · Received October 15, 2018

    Report

    Report Number
    2182208-2018-01875
    Event Type
    Malfunction
    Date Received
    October 15, 2018
    Date of Event
    September 19, 2018
    Report Date
    October 15, 2018
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    KRE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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 CALLER COMPLAINED THAT AFTER THE HL-7 CONFIGURATION IN THE PATIENT MANAGEMENT DATABASE APPLICATION THAT THE MANUFACTURER WAS MOVING THE LOCAL TIME ZONE WAS CHANGING THE DEVICE IMPLANT DATE TO AN EARLIER DATE. AFTER TURNING ON THE ADDITIONAL OUTBOUND ACTION LIST CUSTOMIZATION TO CONVERT TO THE LOCAL TIME, THE CALLER REPORTED THAT THE IMPLANT DATES DISPLAYED UNWANTED FEATURE TIMES FROM THE PREVIOUS DAY. THE ISSUE WAS ESCALATED TO THE DEVELOPER. IT WAS FOUND THAT THE SEND DATE ONLY WOULD UNDONE BY CONVERTING; THEREFORE, OMITTING THE CONVERSION AND ADDING IN NOT EQUAL IF CLAUSES. THE APPLICATION REMAINS IN US. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    808162 PACEART OPTIMA ANALYZER, PACEMAKER GENERATOR FUNCTION, INDIRECT KRE MEDTRONIC, INC. PAOPT17SUP

    Patients

    Seq Age Sex Outcome Treatment
    1