BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 1000

    MDR report key: 17407702 · Received July 27, 2023

    Report

    Report Number
    1644487-2023-01005
    Event Type
    Malfunction
    Date Received
    July 27, 2023
    Date of Event
    January 22, 2023
    Report Date
    November 7, 2025
    Manufacturer
    LIVANOVA USA, INC.
    Product Code
    LYJ
    UDI-DI
    05425025750405
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    LIVANOVA USA, INC. SUBMITS THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION, BASED ON INFORMATION THAT LIVANOVA HAS OBTAINED, BUT MAY NOT HAVE BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION, OR A CONCLUSION BY FDA OR ANYONE ELSE, THAT THE DEVICE, LIVANOVA, OR LIVANOVA'S EMPLOYEES 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 "MALFUNCTIONS¿. THESE WORDS ARE INCORPORATED INTO THE FDA 3500A MEDWATCH FORM BY THE FDA, AND LIVANOVA OBJECTS TO THEIR USE.

    Description of Event or Problem · 0

    IT WAS LATER REPORTED THAT A GENERATOR RESET WAS ATTEMPTED, BUT WAS NOT SUCCESSFUL. NO ADDITIONAL INFORMATION HAS BEEN RECEIVED TO DATE.

    Description of Event or Problem · 0

    THE EXPLANTED DEVICE WAS LATER RECEIVED BY THE MANUFACTURER TO UNDERGO PRODUCT ANALYSIS. ANALYSIS HAS NOT BEEN COMPLETED TO DATE.

    Description of Event or Problem · 0

    THE PATIENT LATER HAD THEIR DEVICE REPLACED. THE EXPLANTED DEVICE WAS COLLECTED FOR RETURN TO MANUFACTURER, BUT HAS NOT BEEN RECEIVED TO DATE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN "INCOMPATIBLE GENERATOR" ERROR MESSAGE WAS RECEIVED WHEN THE PATIENT'S GENERATOR WAS INTERROGATED. TROUBLESHOOTING WAS PERFORMED BY ADDITIONAL PROGRAMMING SYSTEMS, BUT THE SAME ERROR MESSAGE WAS SEEN. THESE PROGRAMMING SYSTEMS WERE ABLE TO SUCCESSFULLY INTERROGATE OTHER PATIENTS. DURING AN INITIAL REVIEW OF THE GENERATOR DATA, THE GENERATOR EXPERIENCED A RESET AND IS STUCK IN THE BOOTLOADER APPLICATION. NO KNOWN RELEVANT SURGICAL INTERVENTION HAS OCCURRED TO DATE. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Description of Event or Problem · 0

    LATER, VENDOR ANALYSIS WAS COMPLETED BY TEXAS INSTRUMENTS (TI). TI TESTED THE MICROCONTROLLER USING THEIR PRODUCTION AUTOMATED TEST EQUIPMENT (ATE) FINAL TEST PROGRAM. THE ATE TEST PASSED. TI PERFORMED BENCH TESTING AND CONFIRMED COMMUNICATION WITH THE CRU, FLASH FIRMWARE AND READ THE REGISTER MAP WITH NO ISSUES. THERE WAS NO DIFFERENCE IN THE REGISTER VALUES BETWEEN THE CORRELATION UNIT AND THE CRU AFTER TESTING. CRC REGISTERS ALL WERE THE SAME AS WELL AND NO RESETS WERE OBSERVED. VENDOR ANALYSIS AT TI FOUND NO FUNCTIONAL ANOMALIES AS CONFIRMED BY ATE AND BENCH TESTING. THE MICROCONTROLLER WAS NOT RETURNED TO LIVANOVA FOLLOWING VENDOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1258326 PULSE GEN MODEL 1000 GENERATOR LYJ LIVANOVA USA, INC. 1000 7150 05425025750405

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown