BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PACEART OPTIMA SYSTEM SOFTWARE

    MDR report key: 12675816 · Received October 21, 2021

    Report

    Report Number
    2182208-2021-04191
    Event Type
    Malfunction
    Date Received
    October 21, 2021
    Date of Event
    October 12, 2021
    Report Date
    October 21, 2021
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    KRE
    PMA / PMN Number
    K110693
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    003

    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 PROGRAMMER REPORT HAD SHOWN AN ESTIMATED LONGEVITY REMAINING OF 7.5 YEARS BUT THE PATIENT MANAGEMENT DATABASE APPLICATION SHOWED REMAINING LONGEVITY AT ONE YEAR AND THREE MONTHS. ADVISED THE PATIENT MANAGEMENT DATABASE APPLICATION HAS CALCULATIONS FOR LONGEVITY BASED ON DEVICE DATA, BUT SHOULD BE LISTING AS PROVIDED BY THE PROGRAMMER DATA. CALLER DID NOT HAVE ACCESS TO THE CUSTOMER'S PATIENT MANAGEMENT DATABASE APPLICATION TO REVIEW. CALLER WILL FOLLOW-UP WITH CUSTOMER AND HAVE THEM REACH OUT WITH ACCESS TO LOOK INTO SOME EXAMPLES. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1570973 PACEART OPTIMA SYSTEM SOFTWARE ANALYZER, PACEMAKER GENERATOR FUNCTION, INDIRE KRE MEDTRONIC, INC. POS12D18

    Patients

    Seq Age Sex Outcome Treatment
    1