BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 106

    MDR report key: 15087711 · Received July 22, 2022

    Report

    Report Number
    1644487-2022-00879
    Event Type
    Malfunction
    Date Received
    July 22, 2022
    Date of Event
    June 29, 2022
    Report Date
    August 17, 2022
    Manufacturer
    LIVANOVA USA, INC.
    Product Code
    LYJ
    UDI-DI
    05425025750061
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE
    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 PATIENT WITH M106 EXPERIENCED ERROR CODE 2 (PULSE WATCHDOG TIMEOUT). PATIENT WAS UNABLE TO PERCEIVE STIMULATION DESPITE BEING SET TO RELATIVELY HIGH SETTINGS. THE PULSE WATCHDOG TIMEOUT IS MEANT TO BE A SAFETY MECHANISM TO PREVENT THE DELIVERY OF UNEXPECTED PULSE WIDTH. IT IS EXTREMELY RARE THAT A DEVICE ENCOUNTERS THIS ERROR. HOWEVER, SOME EVENTS THAT COULD CAUSE A PULSE WATCHDOG TIMEOUT ERROR INCLUDE THE CODE GETTING STUCK IN A POLLING LOOP, A STACK OVERFLOW, TRANSIENT MEMORY ISSUE, OR EVEN A DEEPER HARDWARE PROBLEM. THE GENERATOR DATA DECODER CONFIRMS THAT THE PULSE WATCH DOG TIMEOUT WAS ENCOUNTERED WHEN THE DEVICE WAS INTERROGATED. AFTER THE INITIAL INTERROGATION, THE DEVICE WAS PROGRAMMED, A SYSTEM DIAGNOSTIC WAS RUN, AND THE DEVICE WAS THEN REINTERROGATED. ACCORDING TO THE DECODER, PULSE WAS RE-ENABLED FOLLOWING THE PULSE WATCHDOG TIMEOUT ERROR. THE SYSTEM DIAGNOSTICS WERE WITHIN NORMAL LIMITS AFTER EVENT. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Description of Event or Problem · 0

    THE PROVIDER REPORTED THAT THE PATIENT WAS NOT EXPOSED TO ANY HIGH ENERGY FIELDS, DID NOT UNDERGO ANY RECENT MEDICAL PROCEDURES, AND DID NOT EXPERIENCED ANY ENVIRONMENTAL CHANGES THAT MAY IMPACT THE IPG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    109196 PULSE GEN MODEL 106 GENERATOR LYJ LIVANOVA USA, INC. 106 204230 05425025750061

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Female