BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 106

    MDR report key: 16023181 · Received December 21, 2022

    Report

    Report Number
    1644487-2022-01660
    Event Type
    Injury
    Date Received
    December 21, 2022
    Date of Event
    November 30, 2022
    Report Date
    January 17, 2023
    Manufacturer
    LIVANOVA USA, INC.
    Product Code
    LYJ
    UDI-DI
    05425025750061
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, 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 VIA EMAIL THAT THE PATIENT'S DEVICE WAS DISABLED DUE TO A LOW BATTERY (PULSE DISABLED DUE TO EOS) AND THE PATIENT WAS EXPERIENCING AN INCREASE IN SEIZURES. IMPLANT CARD WAS THEN RECEIVED INDICATING THAT THE PATIENT'S DEVICE WAS EXPLANTED DUE TO NEOS 0-5% BATTERY AND NOT PULSE DISABLED INDICATING THAT THE SEIZURES WERE NOT RELATED TO EOS. THE EXPLANTED DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS TO DATE. NO ADDITIONAL RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE WAS DISABLED ITSELF, AND THE NEURO TURNED IT BACK ON AND GOT SURGERY FOR THE PATIENT THE NEXT WEEK. THE DEVICE IS NOT AVAILABLE FOR RETURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2143365 PULSE GEN MODEL 106 GENERATOR LYJ LIVANOVA USA, INC. 106 204639 05425025750061

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Male Required Intervention