BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL UNKNOWN

    MDR report key: 21946496 · Received May 1, 2025

    Report

    Report Number
    1644487-2025-10073
    Event Type
    Injury
    Date Received
    May 1, 2025
    Date of Event
    October 8, 2024
    Report Date
    May 1, 2025
    Manufacturer
    LIVANOVA USA, INC.
    Product Code
    MUZ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    F10 HEALTH EFFECT, CLINICAL CODE: CODE E2402 UTILIZED; APPROPRIATE TERM ¿SUICIDE ATTEMPT¿ IS NOT AVAILABLE. KEAT, A., LI, K., HAU, T. AND SOGA, T. (2024), COMPARATIVE SIDE-EFFECTS OF NEUROSURGICAL TREATMENT OF TREATMENT-RESISTANT DEPRESSION. CNS NEUROSCITHER, 30: E70090. HTTPS://DOI.ORG/10.1111/CNS.70090. 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

    DURING A REVIEW OF A SCIENCE ARTICLE TITLED "COMPARATIVE SIDE-EFFECTS OF NEUROSURGICAL TREATMENT OF TREATMENT-RESISTANT DEPRESSION", ADVERSE EVENTS WERE REPORTED FOR PATIENTS IMPLANTED WITH A VNS SYSTEM. THE ARTICLE SELECTED VNS STUDIES THRU A LITERATURE SEARCH, WHICH WERE ANALYZED FOCUSING ON PATIENTS WITH TREATMENT RESISTANT DEPRESSION. THE ADVERSE EVENTS OF SUICIDAL IDEATIONS, SUICIDE ATTEMPT, DEHISCENCE WOUND, INCREASED DEPRESSION, AND MANIA WERE REPORTED. NO FURTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    935078 PULSE GEN MODEL UNKNOWN GENERATOR MUZ LIVANOVA USA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other