BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 104

    MDR report key: 15446246 · Received September 19, 2022

    Report

    Report Number
    1644487-2022-01161
    Event Type
    Injury
    Date Received
    September 19, 2022
    Date of Event
    May 1, 2017
    Report Date
    September 19, 2022
    Manufacturer
    CYBERONICS - HOUSTON
    Product Code
    LYJ
    UDI-DI
    05425025750047
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT HAS BEEN CHOKING WITH HIS DEVICE. HE HAS HAD HIS DEVICE FOR SOME TIME AND THE MOTHER INDICATED THAT SHE FEELS IT HAS NEVER REALLY HELPED HIM. HE HAS HAD HIS ESOPHAGUS STRETCHED AT A THROAT SPECIALIST TO HELP WITH THE CHOKING BUT IT ONLY BRIEFLY SOLVED THE ISSUE. THE MOTHER DIDN'T THINK THERE WAS ANY TRAUMA HAD RECENTLY OCCURRED WITH THE DEVICE THAT WOULD HAVE CAUSED THE CHOKING, BUT HE DOES FALL WITH SEIZURES SO SHE WAS NOT SURE. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428596 PULSE GEN MODEL 104 GENERATOR LYJ CYBERONICS - HOUSTON 104 5137 05425025750047

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Male Other