BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 15348463 · Received September 2, 2022

    Report

    Report Number
    1644487-2022-01095
    Event Type
    Injury
    Date Received
    September 2, 2022
    Date of Event
    August 11, 2022
    Report Date
    September 2, 2022
    Manufacturer
    CYBERONICS - HOUSTON
    Product Code
    LYJ
    UDI-DI
    05425025750016
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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.

    Description of Event or Problem · 0

    PATIENT REPORTED THAT HER VNS HAS BEEN OFF FOR YEARS AND HAD OVERWORKED HER BODY. SHE NOTED THAT VNS HURT HER SYSTEM AS WELL. SHE SAID SHE COULD HEAR HER HEARTBEAT WHEN SHE TURNED HER HEAD. NO KNOWN RELEVANT SURGICAL INTERVENTION HAS OCCURRED TO DATE. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1201941 PULSE GEN MODEL 102 GENERATOR LYJ CYBERONICS - HOUSTON 102 203585 05425025750016

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Female Other