BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PACEART OPTIMA SYSTEM SOFTWARE

    MDR report key: 10402259 · Received August 13, 2020

    Report

    Report Number
    2182208-2020-01514
    Event Type
    Malfunction
    Date Received
    August 13, 2020
    Date of Event
    July 27, 2020
    Report Date
    August 13, 2020
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    KRE
    PMA / PMN Number
    K110693
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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 LONGEVITY INFORMATION RECEIVED FROM THE PATIENT MANAGEMENT DATABASE APPLICATION WAS DIFFERENT THAT THE INFORMATION FROM THE REMOTE MONITORING NETWORK. ADVISED CALLER THAT THE PATIENT MANAGEMENT DATABASE APPLICATION CALCULATES REMAINING LONGEVITY DIFFERENTLY THAN THE NETWORK, AND THE CLINICIAN SHOULD FOLLOW WHAT THE NETWORK SHOWS. FURTHER INVESTIGATION IS BEING CONDUCTED. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    865333 PACEART OPTIMA SYSTEM SOFTWARE ANALYZER, PACEMAKER GENERATOR FUNCTION, INDIRECT KRE MEDTRONIC, INC. POS12D18

    Patients

    Seq Age Sex Outcome Treatment
    1