BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 1000

    MDR report key: 18627669 · Received February 1, 2024

    Report

    Report Number
    1644487-2024-00091
    Event Type
    Injury
    Date Received
    February 1, 2024
    Date of Event
    January 10, 2024
    Report Date
    February 1, 2024
    Manufacturer
    CYBERONICS - HOUSTON
    Product Code
    LYJ
    UDI-DI
    05425025750405
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    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 :E0506.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD A BATTERY REPLACEMENT. A COUPLE MONTHS LATER THEY HAD TO GET AIR LIFTED TO A HOSPITAL DUE TO A FALL THAT RESULTED IN A BRAIN BLEED. THERE WERE NO ALLEGATIONS THAT THE FALL WAS DUE TO VNS. THE PHYSICIANS NOTED THAT THE BRAIN BLEED IS RESOLVING IN ITSELF. PATIENT NOTED THAT THE VNS SHOCKS HAVE BEEN INTENSE THAT IS MAKING IT DIFFICULT TO HEAR. PATIENT FURTHER STATES THAT THE PHYSICIAN BELIEVE SHE MAY HAVE NERVE DAMAGE FROM IT. ADDITIONAL INFORMATION WAS RECEIVED NOTING THAT THE DEVICE WAS WITHIN NORMAL LIMITS. IT WAS NOTED THAT THE PATIENT ONLY FELT UNCOMFORTABLE WITH HER MAGNET STIMULATION WHICH WAS NOTED TO BE LOWERED IN PULSE WIDTH AND WAS NOTED TO BE BETTER. FALL WAS NOTED TO BE ON HER RIGHT AND NO VISUAL DAMAGE TO ANY AREAS OF THE VNS. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274506 PULSE GEN MODEL 1000 GENERATOR LYJ CYBERONICS - HOUSTON 1000 7597 05425025750405

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Female Hospitalization| L| R