BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 1000

    MDR report key: 22002505 · Received May 12, 2025

    Report

    Report Number
    1644487-2025-10119
    Event Type
    Injury
    Date Received
    May 12, 2025
    Date of Event
    April 15, 2025
    Report Date
    June 6, 2025
    Manufacturer
    LIVANOVA USA, INC.
    Product Code
    LYJ
    UDI-DI
    05425025750405
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, 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.

    Additional Manufacturer Narrative · 0

    B5 DESCRIBE EVENT OR PROBLEM, CORRECTED DATA: INITIAL REPORT INADVERTENTLY LEFT OUT RELEVANT INFORMATION. D6B IF EXPLANTED, GIVE DATE CORRECTED DATA: INITIAL REPORT INADVERTENTLY DID NOT LIST THE EXPLANT DATE. H6 ADVERSE EVENT PROBLEM, CORRECTED DATA: INITIAL REPORT INADVERTENTLY DID NOT CODE F1905.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAS BEEN EXPERIENCING HICCUPS AND THE PATIENT'S MOM IS QUESTIONING IF THE VNS COULD BE THE CAUSE. THE PATIENT WAS PRESCRIBED MEDICATION, BUT THE HICCUPS HAVE NOT STOPPED. IT WAS ALSO REPORTED THAT THE PATIENT'S BATTERY HAS REACHED NEOS (NEAR END OF SERVICE)=YES AND THIS IS LIKELY THE CAUSE FOR THE PATIENT'S BREAKTHROUGH SEIZURES. THE PATIENT HAS SINCE BEEN REFERRED FOR A BATTERY REPLACEMENT. NO KNOWN SURGICAL INTERVENTION HAS OCCURRED TO DATE. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Description of Event or Problem · 0

    IMPLANT CARD RECEIVED NOTING THAT THE PATIENT UNDERWENT A PROPHYLACTIC BATTERY REPLACEMENT. THE EXPLANTED GENERATOR HAS NOT BEEN RECEIVED BY PRODUCT ANALYSIS TO DATE. ADDITIONAL INFORMATION RECEIVED NOTING THAT THE CAUSE OF THE HICCUPS IS UNKNOWN, AND NO INTERVENTION HAS BEEN TAKEN/PLANNED. THE INCREASE IN SEIZURES WERE NOTED TO BE BELOW PRE-VNS BASELINES LEVELS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    389824 PULSE GEN MODEL 1000 GENERATOR LYJ LIVANOVA USA, INC. 1000 7144 05425025750405

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Male Other