BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LATITUDE PROGRAMMING SYSTEM

    MDR report key: 17772395 · Received September 19, 2023

    Report

    Report Number
    2124215-2023-51043
    Event Type
    Malfunction
    Date Received
    September 19, 2023
    Date of Event
    May 16, 2023
    Report Date
    September 19, 2023
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    OSR
    UDI-DI
    00802526610202
    PMA / PMN Number
    P910077/S159
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS PROGRAMMER WAS THOROUGHLY INSPECTED AND ANALYZED UPON RECEIPT. THE SYSTEM UNDERWENT FUNCTIONAL TESTING AND BASELINE CHECKS WERE COMPLETED. DETAILED ANALYSIS DETERMINED THE ERROR CODES SEEN IN THE FIELD WERE THE RESULT OF A SOFTWARE ISSUE. SIMILAR PRODUCT BEHAVIOR HAS BEEN SEEN PREVIOUSLY AND ANALYSIS OF THOSE OCCURRENCES DETERMINED THIS SOFTWARE ISSUE MAY RESULT WHEN THE MODEL 3300 PROGRAMMER IS ATTEMPTING TO PERFORM AN ACTION AGAINST A SPECIFIC FEATURE IN THE PROGRAMMERS CONTROL CENTER (E.G., MULTIPLE APPLICATION UTILITY OR MAU) THAT IS NO LONGER AVAILABLE AS IT WAS ALREADY TERMINATED. THIS CAN HAPPEN WHEN THE PROGRAMMER IS SHUT DOWN OR WHEN "QUICK STARTING" ANOTHER PULSE GENERATOR (PG) APPLICATION. THIS UNANTICIPATED EVENT SEQUENCE RESULTS IN THE DISPLAY OF AN ERROR CODE, AS WAS SEEN IN THIS PARTICULAR CASE, AND THE NEED TO RESTART THE PROGRAMMER TO CLEAR THE ERROR.

    Description of Event or Problem · 0

    THIS PROGRAMMER WAS THOROUGHLY INSPECTED AND ANALYZED UPON RECEIPT. THE SYSTEM UNDERWENT FUNCTIONAL TESTING AND BASELINE CHECKS WERE COMPLETED. DETAILED ANALYSIS DETERMINED THE ERROR CODES SEEN IN THE FIELD WERE THE RESULT OF A SOFTWARE ISSUE. SIMILAR PRODUCT BEHAVIOR HAS BEEN SEEN PREVIOUSLY AND ANALYSIS OF THOSE OCCURRENCES DETERMINED THIS SOFTWARE ISSUE MAY RESULT WHEN THE MODEL 3300 PROGRAMMER IS ATTEMPTING TO PERFORM AN ACTION AGAINST A SPECIFIC FEATURE IN THE PROGRAMMERS CONTROL CENTER (E.G., MULTIPLE APPLICATION UTILITY OR MAU) THAT IS NO LONGER AVAILABLE AS IT WAS ALREADY TERMINATED. THIS CAN HAPPEN WHEN THE PROGRAMMER IS SHUT DOWN OR WHEN "QUICK STARTING" ANOTHER PULSE GENERATOR (PG) APPLICATION. THIS UNANTICIPATED EVENT SEQUENCE RESULTS IN THE DISPLAY OF AN ERROR CODE, AS WAS SEEN IN THIS PARTICULAR CASE, AND THE NEED TO RESTART THE PROGRAMMER TO CLEAR THE ERROR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1890682 LATITUDE PROGRAMMING SYSTEM EXTERNAL PROGRAMMER OSR BOSTON SCIENTIFIC CORPORATION 3300 017164 00802526610202

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown