BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PACEART OPTIMA SYSTEM SOFTWARE

    MDR report key: 14873494 · Received June 30, 2022

    Report

    Report Number
    2182208-2022-02107
    Event Type
    Malfunction
    Date Received
    June 30, 2022
    Date of Event
    June 2, 2022
    Report Date
    June 30, 2022
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    KRE
    PMA / PMN Number
    K110693
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE EXHIBITED A DIFFERENT LONGEVITY ESTIMATE AFTER USING THE RETRIEVE FROM PROGRAMMER FEATURE DUE TO A PATIENT MANAGEMENT DATABASE APPLICATION SOFTWARE ESTIMATOR ERROR. THE CORRECT CALCULATION WAS PROVIDED. THE ISSUE HAS BEEN ADDRESSED THROUGH THE RELEASE OF NEW SOFTWARE UPDATES. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    960313 PACEART OPTIMA SYSTEM SOFTWARE ANALYZER, PACEMAKER GENERATOR FUNCTION, INDIRE KRE MEDTRONIC, INC. POS12D18

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown