BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 1000

    MDR report key: 20989158 · Received December 20, 2024

    Report

    Report Number
    1644487-2024-01559
    Event Type
    Malfunction
    Date Received
    December 20, 2024
    Date of Event
    November 26, 2024
    Report Date
    January 27, 2025
    Manufacturer
    LIVANOVA USA, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    117

    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

    ADDITIONAL INVESTIGATION INTO THE INTERNAL DATA FROM THE GENERATOR WAS PERFORMED. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS SEEN WITH LOW OUTPUT CURRENT. THE PATIENT'S LEAD IMPEDANCE WAS WITHIN NORMAL LIMITS. WHEN SYSTEM DIAGNOSTICS WERE RUN, THE OUTPUT CURRENT WAS SEEN TO BE OK AND THE IMPEDANCE WAS ALSO OK. ADDITIONAL INFORMATION WAS RECEIVED THAT WHEN THE PHYSICIAN RAN SYSTEM DIAGNOSTICS, THE OUTPUT CURRENT WAS SEEN TO BE LOW AND AN ERROR MESSAGE OF "TEST NOT COMPLETE" APPEARS. THE PHYSICIAN CONFIRMED THAT ADVANCED INTERROGATION WAS CHECKED. SHE NOTED BOTH THE LOW OUTPUT MESSAGE AND TEST NOT COMPLETE MESSAGE SHOWED UP. ADDITIONAL INFORMATION WAS RECEIVED FROM THE PHYSICIAN NOTING NO ERROR CODES WERE SEEN, HOWEVER THE LOW OUTPUT MESSAGE APPEARED AFTER TRYING TO PERFORM MAGNET DIAGNOSTICS ON THE PATIENT'S DEVICE. THE PATIENT HAD NOT EXPERIENCED ANY RECENT TRAUMA OR MANIPULATION. THE PATIENT'S LATEST SESSION REPORT WAS PROVIDED: NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2131153 PULSE GEN MODEL 1000 GENERATOR LYJ LIVANOVA USA, INC. 1000 206322

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Female