BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 1000

    MDR report key: 19341432 · Received May 17, 2024

    Report

    Report Number
    1644487-2024-00563
    Event Type
    Injury
    Date Received
    May 17, 2024
    Date of Event
    October 7, 2022
    Report Date
    August 28, 2024
    Manufacturer
    LIVANOVA USA, INC.
    Product Code
    LYJ
    UDI-DI
    05425025750405
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 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 INDICATING THAT THE PATIENT ALSO EXPERIENCED JAW PAIN DUE TO STIMULATION. ADDITIONAL INFORMATION RECEIVED NOTING THAT THE PATIENT STARTED EXPERIENCING LEFT NECK AND JAW PAIN AND A BUZZING SENSATION 3 WEEKS AFTER THEY WERE IMPLANTED IN 2022. NECK X-RAYS WERE COMPLETED BUT NO PROBLEMS WERE IDENTIFIED AND THE ADVERSE EVENTS CONTINUES SO THE PATIENT ENDED UP UNDERGOING A REPLACEMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A BATTERY REPLACEMENT DUE TO EXPERIENCING PAIN/DISCOMFORT WITH STIMULATION WHICH CAUSED HER TO CRY OUT AND CLUTCH AT HER NECK SINCE THE DEVICE WAS IMPLANTED. THE PAIN HAS SINCE RESOLVED WITH THE NEWLY IMPLANTED GENERATOR. THE SUSPECT DEVICE WAS RECEIVED BUT PRODUCT ANALYSIS IS STILL UNDERWAY. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Description of Event or Problem · 0

    PRODUCT ANALYSIS WAS COMPLETED ON THE RETURNED GENERATOR. THERE WERE NO PERFORMANCE, OR ANY OTHER TYPE OF ADVERSE CONDITIONS FOUND WITH THE PULSE GENERATOR.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED NOTING THAT THE SURGICAL INTERVENTION WAS FOR PATIENT COMFORT ONLY AND THE SETTINGS FROM (B)(6) 2023 WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    920619 PULSE GEN MODEL 1000 GENERATOR LYJ LIVANOVA USA, INC. 1000 7144 05425025750405

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Female Required Intervention