BEUDAMED
    FDA Adverse Event Death Summary report: N

    PULSE GEN MODEL UNK

    MDR report key: 21403378 · Received February 18, 2025

    Report

    Report Number
    1644487-2025-00186
    Event Type
    Death
    Date Received
    February 18, 2025
    Date of Event
    May 1, 2005
    Report Date
    February 18, 2025
    Manufacturer
    LIVANOVA USA, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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 HAVE NOT 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: E010904, HEALTH EFFECT - CLINICAL CODE: E010901, HEALTH EFFECT - IMPACT CODE: F1202, HEALTH EFFECT - IMPACT CODE: F02.

    Description of Event or Problem · 0

    SCIENTIFIC ARTICLE WAS RECEIVED AND REVIEWED WHERE IT WAS REPORTED THAT 3.8% OF THE PATIENTS IN THIS STUDY EXHIBITED INCREASED SEIZURE FREQUENCY. INFECTIONS WERE SEEN IN 2.6% OF THE PATIENTS AND 1.1% OF THE PATIENTS HAD VOCAL CORD PARALYSIS. ERYTHEMA IN THE INSERTION SITE, KELOID, DIZZINESS AND MALIGNANT HYPERTHERMIA-LIKE EPISODE IN ONE PATIENT EACH. THIRTY-FOUR PATIENTS (18.0 %) DISCONTINUED VNS. THE VNS DEVICE WAS REMOVED IN NINE (4.8 %) PATIENTS, WITH FIVE CASES ATTRIBUTED TO INFECTION AND THE REMAINING FOUR DUE TO LACK OF RESPONSE. FOURTEEN PATIENTS DIED DURING THE OVERALL FOLLOW-UP. BASED ON THE DEATH STATISTICS, THE CAUSE OF DEATH WAS EPILEPSY OR STATUS EPILEPTICUS IN SIX PATIENTS. ONE SUDDEN UNEXPECTED DEATH (SUDEP) WAS IDENTIFIED. NO PATIENT IDENTIFYING INFORMATION WAS PROVIDED. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2642002 PULSE GEN MODEL UNK GENERATOR LYJ LIVANOVA USA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death| S| R