BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 1000

    MDR report key: 19917675 · Received August 6, 2024

    Report

    Report Number
    1644487-2024-00994
    Event Type
    Injury
    Date Received
    August 6, 2024
    Date of Event
    March 25, 2021
    Report Date
    August 15, 2024
    Manufacturer
    LIVANOVA USA, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    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. HEALTH EFFECT - CLINICAL CODE :E0705. HEALTH EFFECT - CLINICAL CODE :E010901. HEALTH EFFECT - CLINICAL CODE :E102802.

    Additional Manufacturer Narrative · 0

    H10 RELATED REPORT NUMBERS, CORRECTED DATA: INITIAL REPORT INADVERTENTLY LEFT BLANK.

    Description of Event or Problem · 0

    AN ARTICLE TITLED "VAGUS NERVE STIMULATION IN MEDICALLY REFRACTORY EPILEPSY: ADVERSE EFFECTS AND CLINICAL CORRELATES" WAS REVIEWED AND REVEALED THAT 8 OUT OF THE 43 PATIENTS IN THE STUDY EXPERIENCED SEVERE SIDE EFFECTS AND 6 PATIENTS WERE ADMITTED INTO THE ICU. MAJOR SIDE EFFECTS: -17 PATIENTS EXPERIENCED DYSPHAGIA, 10 PATIENT'S EXPERIENCED DYSPNEA, 3 PATIENT'S EXPERIENCED SNORING, 4 PATIENT'S EXPERIENCED ASPIRATION PNEUMONIA, PATIENT'S ALSO EXPERIENCES INCREASED SEIZURE FREQUENCY AND INCREASE IN SECRETIONS (CAPTURED IN THIS REPORT, MFR. REPORT # 1644487-2024-00994) -1 PATIENT PASSED AWAY (CAPTURED IN MFR. REPORT # 1644487-2024-00927) NO FURTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1648199 PULSE GEN MODEL 1000 GENERATOR LYJ LIVANOVA USA, INC. 1000

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| O