BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 1000

    MDR report key: 22872418 · Received August 22, 2025

    Report

    Report Number
    1644487-2025-10523
    Event Type
    Injury
    Date Received
    August 22, 2025
    Date of Event
    August 1, 2021
    Report Date
    April 17, 2026
    Manufacturer
    LIVANOVA USA, INC.
    Product Code
    LYJ
    UDI-DI
    05425025750405
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    003

    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 SINCE HAVING THE DEVICE PLACED THE PATIENT HAS EXPERIENCED SNORING. THE PATIENT THEN UNDERWENT A POLYSOMNOGRAPHY AND WAS DIAGNOSED WITH APNEA. THE PATIENT'S PHYSICIAN ADJUSTED THEIR VNS SETTINGS TO PREVENT SEIZURES BUT AFTER THIS, THE SNORING AND WHEEZING INCREASED FOR THE PATIENT. IT WAS REPORTED THAT THE PATIENT USES THE MEDICATIONS LAMOTRISINE, FRISIO, AND FLUOXETINE, BUT SHE WAS UNABLE TO SAY HOW OFTEN SHE USES THEM BECAUSE SHE IS TRAVELING. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Description of Event or Problem · 0

    DETAILS FROM THE POLYSOMNOGRAPHY TEST THAT WAS PERFORMED WAS RECEIVED. FULL-NIGHT POLYSOMNOGRAPHY PERFORMED IN GOOD TECHNICAL CONDITIONS, STARTING AT 9:45:58 P.M. AND END AT 4:56:30 A.M., WITH LATENCY TO NON-REM SLEEP OF 0.0 MINUTES AND LATENCY TO REM SLEEP OF 148.5 MINUTES. THE TOTAL SLEEP TIME WAS 424.5 MINUTES, WITH AN EFFICIENCY OF 98.5%. SLEEP DISTRIBUTION SHOWED 1.2% STAGE N1, 88.0% STAGE N2, 0.0% STAGE N3 (SLOW-WAVE SLEEP), AND 10.8% REM SLEEP. OR WAKEFULNESS TIME AFTER SLEEP ONSET (WASO) WAS 6.5 MINUTES. AWAKENINGS (5) AND MICRO-AWAKENINGS (140) FRAGMENTED SLEEP WITH AN INDEX OF 20.5/HOUR. THE APNEA/HYPOPNEA INDEX WAS 19.2/HOUR, 4.5 APNEA/HOUR AND 14.7 HYPOPNEA/HOUR. THE NUMBER OF RESPIRATORY EVENTS WAS 136, OF WHICH 135 WERE OBSTRUCTIVE, 1 CENTRAL AND 0 MIXED. THE INDEX OF VENTILATORY DISORDER (VTI = APNEA + HYPOPNEA INDEX + RERA) WAS 19.2/HOUR AND THE NUMBER OF RERAS WAS 0. THE MAXIMUM DURATION OF APNEAS AND HYPOPNEA WAS 72.8 SECONDS. APNEAS AND HYPOPNEAS PREDOMINATED DURING STAGE 2 OF NON-REM SLEEP (INDEX OF 18.5 /HOUR) AND REM STAGE (INDEX OF 0.7 /HOUR). SNORING WERE RECORDED 0 TIMES, WITH AN INDEX OF 0.0 /HOUR. BASELINE OXYHEMOGLOBIN SATURATION WAS OF 96%, WITH AN AVERAGE SATURATION OF 94.9%, A HIGHER THAN 98% AND A MINIMUM OF 90%, REMAINING 0.0% OF THE RECORDING TIME WITH SATURATION BELOW 90% AND 0.0% OF THE TIME WITH SATURATION BELOW 80%. THERE WERE 18 OXYHEMOGLOBIN DESATURATIONS. THE SATO2 WAS 0.0 MINUTES BELOW 90%. THERE WAS 0 PLM (0.0/HOUR INDEX), AND 0 LOWER LIMB MOVEMENTS (INDEX 0.0/HOUR). THE POLYSOMNOGRAPHY RESULTED IN THE PATIENT BEING DIAGNOSED WITH APNEA.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED NOTING THAT THE PATIENT STARTED USING THE CPAP AND THEY HAVE SHOWN IMPROVEMENT. THE BELIEVED CAUSE OF THE SLEEP APNEA IS RELATED TO THE VNS ALTHOUGH THE PHYSICIANS CANNOT SAY WITH CERTAINTY. THE PATIENT STARTED USING A CPAP TO AVOID SERIOUS INJURIES AND TO IMPROVE THEIR QUALITY OF LIFE.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED NOTING THAT THE PATIENT'S REPORTED SYMPTOMS INCLUDE SNORING, WHEEZING IN THE CHEST, UNUSUAL BREATHING SOUNDS, EVEN WITH THE MOUTH CLOSED, AS WELL AS ¿SIGHS.¿ THESE SIGNS APPEARED AFTER THE START OF VNS USE AND DID NOT OCCUR BEFORE THE IMPLANT, AND THERE IS A MEDICAL SUSPICION OF A POSSIBLE RELATIONSHIP BETWEEN THE DEVICE AND WORSENING RESPIRATION, ALTHOUGH THIS HAS NOT YET BEEN CONFIRMED. ACCORDING TO THE MOTHER'S REPORT, THE USE OF CPAP WAS INDICATED AS A PREVENTIVE MEASURE AGAINST SERIOUS INJURIES, AND NOT JUST FOR COMFORT. THE RECOMMENDATION WAS MADE DURING A CONSULTATION IN 2024, BUT THE PATIENT INITIALLY REFUSED. SINCE FEBRUARY 2025, THERE HAS BEEN A SIGNIFICANT WORSENING OF SYMPTOMS: EXCESSIVE SLEEPINESS, INTENSE FATIGUE, AND WORSENING OF THE RESPIRATORY CONDITION. RECENTLY, THE PATIENT AGREED TO START USING CPAP, ALTHOUGH SHE HAS NOT YET BEGUN. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED. IT WAS NOTED THAT THE GENERATOR WAS DISCARDED AND THAT THE EXPLANT WAS DUE TO BATTERY DEPLETION. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Description of Event or Problem · 0

    IT WAS LATER REPORTED THAT THE PATIENT'S BATTERY WAS REPLACED. NO REASON WAS PROVIDED. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260617 PULSE GEN MODEL 1000 GENERATOR LYJ LIVANOVA USA, INC. 1000 205548 05425025750405

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Female Other