BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 106

    MDR report key: 18544756 · Received January 19, 2024

    Report

    Report Number
    1644487-2024-00061
    Event Type
    Injury
    Date Received
    January 19, 2024
    Date of Event
    December 18, 2023
    Report Date
    March 1, 2024
    Manufacturer
    LIVANOVA USA, INC.
    Product Code
    LYJ
    UDI-DI
    05425025750061
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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

    ADDITIONAL INFORMATION RECEIVED NOTING THAT THE PATIENT UNDERWENT A SLEEP STUDY AND SHE EXPERIENCED A DECREASE IN O2 SATURATION. THE PATIENT ALSO REPORTS THAT HER SEIZURE FREQUENCY IS LESS, BUT IT SEEMS THAT WHEN SHE HAS A BREAKTHROUGH SEIZURE, THEY ARE MORE INTENSE, BUT SHE IS ABLE TO RECOVER MORE QUICKLY. THE PHYSICIAN JUST NOTES THAT THE PATIENT HAS ANXIETY (NOT ALLEGED AGAINST THE VNS) BUT NEVER HAD HYPOXIA TRIGGERED BY ANXIETY. THE PHYSICIAN WOULD LIKE TO STAY ON THE CURRENT MEDICATION AND VNS SETTINGS UNTIL THEYRE ABLE TO RESOLVE THE HYPOXIA ISSUE, NO ADDITIONAL INTERVENTION WAS NOTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED BREATHING ISSUES WITH LOW OXYGEN. THE PATIENT WAS REFERRED TO A PULMONOLOGIST TO CONFIRM THE REPORTED EVENTS. THE PATIENT REPORTS EXPERIENCING MULTIPLE HYPOXIA EVENTS WHICH RESOLVED BY ITSELF WITHOUT ANY INTERVENTION. INFORMATION RECEIVED FROM THE PHYSICIAN NOTING THAT WHEN THE PATIENT WAS SET TO NORMAL 1MA/MAGNET 1MA/ AUTOSTIM 1.25MA THEY EXPERIENCED ONE EVENT OF HYPOXIA 75% WITHOUT A SEIZURE AND 2 EVENTS OF SEIZURES WITH HYPOXIA. WHEN SET TO NORMAL 0.75MA/MAGNET 0.75MA/ AUTOSTIM 1 MA THEY EXPERIENCED A SEIZURE WITH LOW OXYGEN, 89%. WHEN SET TO NORMAL 0.25MA/MAGNET 0.25MA/ AUTOSTIM 0.25 MA THEY EXPERIENCED A LOW OXYGEN 50% EVENT WITH NO SEIZURE. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2476221 PULSE GEN MODEL 106 GENERATOR LYJ LIVANOVA USA, INC. 106 834 05425025750061

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Female Other