BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 106

    MDR report key: 16742226 · Received April 14, 2023

    Report

    Report Number
    1644487-2023-00457
    Event Type
    Malfunction
    Date Received
    April 14, 2023
    Date of Event
    March 21, 2023
    Report Date
    February 20, 2024
    Manufacturer
    LIVANOVA USA, INC.
    Product Code
    LYJ
    UDI-DI
    05425025750061
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 LIVANOVAS 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

    INFORMATION WAS LATER RECEIVED THAT INCLUDED THE PATIENT'S MOST RECENT SESSION REPORT. THE GENERATOR INFORMATION WAS PROVIDED WHICH INDICATES THIS EVENT OCCURRED WITH A DIFFERENT PATIENT THAN ORIGINALLY REPORTED.

    Description of Event or Problem · 0

    THE SUSPECT DEVICE (GENERATOR) WAS RECEIVED BY THE MANUFACTURER TO UNDERGO PRODUCT ANALYSIS. ANALYSIS HAS NOT BEEN COMPLETED TO DATE.

    Description of Event or Problem · 0

    IT WAS LATER REPORTED THAT THE PATIENT UNDERWENT A BATTERY REPLACEMENT DUE TO BATTERY DEPLETION. THE EXPLANTED GENERATOR WILL BE RETURNED FOR PRODUCT ANALYSIS, BUT HAS NOT BEEN RECEIVED TO DATE. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Description of Event or Problem · 0

    THE PATIENT'S PHYSICIAN LATER REPORTED THAT THE INCREASED SEIZURES WERE BELOW PRE-VNS BASELINE LEVELS AND RELATED TO EXTERNAL FACTORS. THEY NOTED IT WAS UNCLEAR AS THE EPISODES CAN BE AGITATION VS. SEIZURE POTENTIALLY CAN BE DUE TO A SUBTLE INFECTIOUS PROCESS AS WELL, OR PROGRESSION OF REFRACTORY EPILEPSY. THE PATIENT WAS GIVEN A DOSE OF RESCUE MEDICATION FOR THE CONCERN OF CLUSTER SEIZURES, AND THE SEIZURES SEEMED TO SUBSIDE BACK TO USUAL. THEY ARE WAITING FOR AN EPILEPSY MONITORING UNIT (EMU). THE INFECTIOUS PROCESS WAS NOT ALLEGED AGAINST VNS.

    Description of Event or Problem · 0

    PRODUCT ANALYSIS WAS COMPLETED ON THE RETURNED GENERATOR. THE BATTERY WAS RETURNED FOLLOWING BATTERY REPLACEMENT DUE TO LOW BATTERY. THE LOW BATTERY CONDITION WAS CONFIRMED. THERE WERE NO OTHER ANOMALIES IDENTIFIED, AND THE DEVICE PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT IS HAVING A LOT OF BREAKTHROUGH SEIZURES. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    393139 PULSE GEN MODEL 106 GENERATOR LYJ LIVANOVA USA, INC. 106 6466 05425025750061

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Male