BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PACEART OPTIMA SYSTEM SOFTWARE

    MDR report key: 12073028 · Received June 27, 2021

    Report

    Report Number
    2182208-2021-02603
    Event Type
    Malfunction
    Date Received
    June 27, 2021
    Date of Event
    June 8, 2021
    Report Date
    June 27, 2021
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    KRE
    PMA / PMN Number
    K110693
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED ISSUE IS ASSOCIATED WITH A KNOWN ADVISORY RELATED TO THE POTENTIAL FOR MEDTRONIC PROGRAMMER AND REMOTE MONITORING SOFTWARE APPLICATIONS TO DISPLAY AN INACCURATE REMAINING LONGEVITY ESTIMATE. A RECALL NUMBER IS NOT AVAILABLE IN THIS INSTANCE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPLANTED DEVICE EXHIBITED SHORTER THAN EXPECTED LONGEVITY ESTIMATE DUE A PATIENT MANAGEMENT DATABASE APPLICATION SOFTWARE ESTIMATOR ERROR. THE CORRECT CALCULATION WAS PROVIDED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    969835 PACEART OPTIMA SYSTEM SOFTWARE ANALYZER, PACEMAKER GENERATOR FUNCTION, INDIRE KRE MEDTRONIC, INC. POS12D18

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR