BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 1000

    MDR report key: 23127535 · Received September 23, 2025

    Report

    Report Number
    1644487-2025-10645
    Event Type
    Injury
    Date Received
    September 23, 2025
    Date of Event
    August 28, 2025
    Report Date
    December 4, 2025
    Manufacturer
    LIVANOVA USA, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    PHYSICIAN
    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

    ADDITIONAL INFORMATION RECEIVED NOTING THE PATIENT EXPERIENCED BRADYCARDIA AND THEIR HEART RATE PRIOR TO THE EVENT WAS 70-80S AND DURING THE EVENT IT WAS 20-31. THE BRADYCARDIA OCCURRED ON (B)(6) 2025 AND IT WAS NOTED THAT A TRIGGER WAS MEDICATION WITHDRAWAL WHILE THE PATIENT WAS IN THE EPILEPSY MONITORING UNIT. THE PATIENT'S MEDICATION WAS DISCONTINUED TO PROVOKE SEIZURES. THE ARRHYTHMIA DID NOT CORRELATE TO THE ON TIME OF THE VNS AND IT DID NOT OCCUR DURING DIAGNOSTICS. AN ECG AND ECHO WAS PERFORMED. THE BRADYCARDIA WAS ASSESSED AS NOT BEING RELATED TO THE VNS. NO INTERVENTION WAS TAKEN AND THE DEVICE IS CURRENTLY PROGRAMMED ON. THE EVENT HAS NOT RECURRED SINCE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING BRADYCARDIA IN THE EMU DURING SEIZURES. THE VNS WAS DISABLED AND THERE WERE NO BRADY EPISODES. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    542004 PULSE GEN MODEL 1000 GENERATOR LYJ LIVANOVA USA, INC. 1000 7775

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Male Other