BEUDAMED
    FDA Adverse Event Death Summary report: N

    PULSE GEN MODEL 1000

    MDR report key: 19666599 · Received July 3, 2024

    Report

    Report Number
    1644487-2024-00835
    Event Type
    Death
    Date Received
    July 3, 2024
    Date of Event
    June 11, 2024
    Report Date
    July 3, 2024
    Manufacturer
    CYBERONICS - HOUSTON
    Product Code
    LYJ
    UDI-DI
    05425025750405
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, 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.

    Description of Event or Problem · 0

    IT WAS REPORTED FROM THE PATIENT'S PHYSICIAN THAT THE PATIENT PASSED AWAY. UPDATE WAS RECEIVED FROM THE PHYSICIAN AND MEDICAL EXAMINER. PER THE PHYSICIAN, THE CAUSE OF DEATH WAS DUE TO SUPED AND THE PHYSICIAN DOES NOT BELIEVE THE DEATH IS RELATED TO VNS. RESPONSE FROM THE MEDICAL EXAMINER WAS RECEIVED AND STATED THAT THE PATIENT'S DEATH WAS DUE TO THE PATIENT'S CONDITION. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    760368 PULSE GEN MODEL 1000 GENERATOR LYJ CYBERONICS - HOUSTON 1000 7843 05425025750405

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Female Death