BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PACEART OPTIMA

    MDR report key: 4314110 · Received December 10, 2014

    Report

    Report Number
    2182208-2014-03724
    Event Type
    Malfunction
    Date Received
    December 10, 2014
    Date of Event
    October 14, 2014
    Report Date
    October 14, 2014
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    KRE
    PMA / PMN Number
    K110693
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    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 BATTERY CELL IMPEDANCE GRAPHS HAVE BEEN SHOWING INCORRECT VALUES IN THE PATIENT MANAGEMENT DATABASE APPLICATION (DB). TECHNICAL SUPPORT (TS) EXPLAINED THAT DB TAKE THE DATA THAT IS GIVEN SO THE GRAPH SHOULD BE BASED ON WHATEVER THE DATA THE DEVICE WAS SENDING. THE CLIENT SAID THAT THE TRANSMISSIONS WERE COMING IN FROM SESSION SYNC (SS) OR RETRIEVE FROM PROGRAMMER (RFP) AND NO ONE IN THE CLINIC IS MANUALLY CHANGING OR ADDING ANY OF THE VALUES IN DB. TS ASKED THE CLIENT TO GET SAVE TO DISK FILES OF THE ENCOUNTERS FOR AT LEAST ONE OF THE PATIENTS SO REPLICATE. 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
    803214 PACEART OPTIMA ANALYZER, PACEMAKER GENERATOR FUNCTION, INDIRECT KRE MEDTRONIC, INC. POS12D14

    Patients

    Seq Age Sex Outcome Treatment
    1