BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PACEART OPTIMA

    MDR report key: 4159036 · Received October 10, 2014

    Report

    Report Number
    2182208-2014-02590
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Date of Event
    July 31, 2014
    Report Date
    July 31, 2014
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    KRE
    PMA / PMN Number
    K110693
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CLIENT MENTIONED SEVERAL TIMES THAT THE DATA ISSUES HAD NOT BEEN FIXED IN THE NEW RELEASE OF THE PATIENT MANAGEMENT DATABASE (DB). THE CLIENT WOULD LIKE IT BE FIXED IN THE NEXT RELEASE. THE CLIENT HAD GIVEN A LIST OF DATA ISSUES TO SOMEONE AT HUMAN RESOURCES. THE CLIENT HAS TO MANUALLY CHANGE OR ADD THE DATA BECAUSE THE DATA WAS NOT COMING IN CORRECTLY. THE CLIENT NOTED THAT THE PERCENTAGE OF PACING FOR A DEVICE IN MANAGED VENTRICULAR PACING (MVP) MODE POPULATE ERRONEOUSLY, THE SINGLE CHAMBER PACING MODES POPULATE THE UPPER TRACKING RATE WHICH DOES NOT APPLY TO SINGLE CHAMBER PACING, AND THE ATRIAL REFRACTORY DOES NOT POPULATE. DB REMAINS IN USE. NO PATIENT INVOLVEMENT OR COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    641403 PACEART OPTIMA ANALYZER, PACEMAKER GENERATOR FUNCTION, INDIRECT KRE MEDTRONIC, INC. POS12D14

    Patients

    Seq Age Sex Outcome Treatment
    1