BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GENERATOR MODEL 1000

    MDR report key: 22669789 · Received July 30, 2025

    Report

    Report Number
    1644487-2025-10439
    Event Type
    Malfunction
    Date Received
    July 30, 2025
    Date of Event
    October 3, 2024
    Report Date
    January 22, 2026
    Manufacturer
    HOUSTON
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B5. DESCRIBE EVENT; CORRECTED INFORMATION; FOLLOW-UP MDR #2 INADVERTENTLY OMITTED INFORMATION KNOWN PRIOR TO SUBMISSION.

    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

    PRODUCT ANALYSIS TESTING NOT INCLUDED ON THE INITIAL ANALYSIS WAS PROVIDED. REED SWITCH FUNCTIONALITY WAS CONFIRMED TO BE FREE OF ANOMALIES AT THE TIME OF THE REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A BATTERY REPLACEMENT, THE PATIENT WAS INTERROGATED AND DIAGNOSTICS SHOWED: BATTERY 25-50%, OUTPUT CURRENT LOW, AND IMPEDANCE 2784. DIAGNOSTICS WERE RE-ATTEMPTED HOWEVER ERROR CODE 254 WAS SEEN. THE DEVICE WAS EXPLANTED. IT WAS ALSO REPORTED THAT DURING PRE-OP CHECK; THE PATIENT REPORTED THAT THEY HAD NOT FELT STIMULATION FOR SOME TIME. THE PATIENT ALSO MENTIONED THAT THEY WERE REFERRED TO THEIR SURGEON AT THE END OF JUNE DUE TO SIMILAR ERROR AT PHYSICIAN OFFICE CHECKUP. THE DEVICE WAS EXPLANTED AND HAS NOT BEEN RECEIVED BY THE MANUFACTURER TO DATE. GENERATOR INTERNAL DATA REVEALED THAT THE DEVICE WAS NOT SUPPLYING STIMULATION DUE TO A MALFUNCTION ASSOCIATED WITH THE GENERATOR'S REED SWITCH.

    Description of Event or Problem · 0

    LATER ANALYSIS OF THE GENERATOR WAS COMPLETED. THE REED SWITCH ISSUE COULD NOT BE DUPLICATED IN THE PRODUCT ANALYSIS LAB, INDICATING THAT THE ISSUE HAD LIKELY RESOLVED PRIOR TO ANALYSIS BEING CONDUCTED.

    Description of Event or Problem · 0

    THE SUSPECT DEVICE WAS RECEIVED BY THE MANUFACTURER. ANALYSIS HAS NOT BEEN COMPLETED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314827 GENERATOR MODEL 1000 GENERATOR LYJ HOUSTON GENERATOR, MODEL 1000 6337

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Unknown