BEUDAMED
    FDA Adverse Event Death Summary report: N

    LEAD MODEL 304

    MDR report key: 16174400 · Received January 16, 2023

    Report

    Report Number
    1644487-2023-00061
    Event Type
    Death
    Date Received
    January 16, 2023
    Date of Event
    December 1, 2022
    Report Date
    February 17, 2023
    Manufacturer
    LIVANOVA USA, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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 THAT PHYSICIAN DETERMINED THE CAUSE OF DEATH TO NOT BE RELATED TO VNS IN ANYWAY. DEATH WAS REPORTED TO BE EXTERNAL CAUSE, NOT RELATED TO VNS. THE ACTUAL CAUSE REMAINS UNKNOWN, BUT IS NOT SUPPLEMENTAL INFORMATION TO THE REPORT AS IT IS NOT RELATED TO VNS. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED VOCAL CORD PARALYSIS, CYANOSIS, DYSPNEA, HYPOXIA AND AN EXACERBATION OF APNEA. PATIENT IS REPORTED TO HAVE EXPERIENCED VOCAL CORD PARALYSIS AS WELL. IN EARLY (B)(6) 2022 HE HAD A SIGNIFICANT RESPIRATORY EVENT WITH HYPOXIA AND CYANOSIS DURING SLEEP, REQUIRING EMERGENCY ROOM EVALUATION. PATIENT UNDERWENT IMAGINING IN WHICH NO ANOMALIES WERE IDENTIFIED. THE PATIENT'S SETTINGS WERE DECREASED AS A RESULT. FOLLOW UP WITH THE PHYSICIAN REVEALS THAT THE REPORTED DYSPNEA, APNEA, HYPOXIA, CYANOSIS HAVE BEEN DETERMINED TO BE NOT RELATED TO VNS THERAPY OR SURGERY. THE PATIENT WAS LATER REPORTED TO HAVE PASSED AWAY. THE PHYSICIAN DOES NOT BELIEVE THAT THE VNS IS DIRECTLY RELATED. VNS HAS NOT BEEN RULED OUT HOWEVER. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    750695 LEAD MODEL 304 LEAD LYJ LIVANOVA USA, INC. 304-20 3779

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Male Death| S