BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 1000

    MDR report key: 23556014 · Received November 14, 2025

    Report

    Report Number
    1644487-2025-10830
    Event Type
    Malfunction
    Date Received
    November 14, 2025
    Date of Event
    October 22, 2025
    Report Date
    January 9, 2026
    Manufacturer
    LIVANOVA USA, INC.
    Product Code
    LYJ
    UDI-DI
    05425025750405
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION G1: MANUFACTURING SITE FACILITY NAME, INITIAL REPORT INADVERTENTLY USED WRONG NAME. LIVANOVA USA, INC. WILL BE USED.

    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 THE PATIENT UNDERWENT GENERATOR REPLACEMENT. IMPEDANCE ISSUE WAS RESOLVED AFTER THE GENERATOR WAS REPLACED. IT WAS ALSO NOTED THAT THE GENERATOR WAS DISCARDED AND WILL NOT BE RETURNED. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED. THE PROVIDER STATED THAT NO X-RAYS WERE PREFORMED, NO TRAUMA OR MANIPULATIONS WERE NOTED. TABLET DATA WAS NOT PROVIDED. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS PREPARING FOR A BATTERY REPLACEMENT WHEN HIGH IMPEDANCE WAS SEEN IN PRE-OP. SURGERY WAS RESCHEDULED TO INCLUDE LEAD REPLACEMENT. NO KNOWN RELEVANT SURGICAL INTERVENTION HAS OCCURRED TO DATE. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2786059 PULSE GEN MODEL 1000 GENERATOR LYJ LIVANOVA USA, INC. 1000 205061 05425025750405

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Unknown