BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 1000

    MDR report key: 19893091 · Received August 2, 2024

    Report

    Report Number
    1644487-2024-00978
    Event Type
    Malfunction
    Date Received
    August 2, 2024
    Date of Event
    July 11, 2023
    Report Date
    August 2, 2024
    Manufacturer
    CYBERONICS - HOUSTON
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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 ERROR CODE 350 AND 128 WAS SEEN UPON INTERROGATION. A TABLET AND WAND RESET WAS PERFORMED AND ADDITIONAL TROUBLESHOOTING WAS GIVEN. IT WAS REPORTED THAT THE ERROR CODE NEVER RESOLVED, EVEN AFTER RESETTING THE WAND AND TABLET, REDUCING EMI, CHANGING WAND BATTERIES, AND ROTATING THE WAND ANGLE. THE WAND WAS RECEIVED INTO PRODUCT ANALYSIS. IN WHICH NO ANOMALIES WERE IDENTIFIED. LATER, IT WAS REPORTED THAT DESPITE TROUBLESHOOTING (A WAND RESET, BATTERIES TAKEN OUT AND REPLACED ON WAND, TABLET RESET, USB CABLES USED, AND REPLACEMENT TABLET UTILIZED) THE ERROR CODE HAD PERSISTED. THE GENERATOR IS PLANNED TO BE REPLACED PENDING THE MANUFACTURER'S REVIEW OF THE DATA. DURING THIS REVIEW OF THE GENERATOR'S DATA, IT WAS DISCOVERED THAT THE NO ISSUES COULD BE IDENTIFIED WITH THE GENERATOR. THE DEVICE WAS NOTED TO HAVE SUCCESSFULLY BEEN INTERROGATED BETWEEN THE DATE OF THE FIRST FAILURE TO COMMUNICATE REPORT AND THE LAST, INDICATING THIS ISSUE WAS INTERMITTENT, INDICATING THAT THE ISSUE LIKELY DOES NOT RESIDE WITHIN THE GENERATOR. FURTHER INVESTIGATION IS REQUIRED TO CONFIRM THIS SPECULATION NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    885525 PULSE GEN MODEL 1000 GENERATOR LYJ CYBERONICS - HOUSTON 1000 6804

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female