BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 1000

    MDR report key: 22493204 · Received July 14, 2025

    Report

    Report Number
    1644487-2025-10354
    Event Type
    Malfunction
    Date Received
    July 14, 2025
    Date of Event
    May 1, 2025
    Report Date
    August 1, 2025
    Manufacturer
    LIVANOVA USA, INC.
    Product Code
    LYJ
    UDI-DI
    05425025750139
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, 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

    PER REPORT, THE PIN WAS SEEN TO BE FULLY INSERTED AT THE TIME OF INITIAL IMPLANT, CLICKS WERE ABLE TO BE HEARD WHEN SCREWING THE LEAD IN, AND AN ACCESSORY PACK WAS USED TO TEST IT. AT THE TIME OF REVISION, THE PROXIMAL COIL WAS SEEN TO BE FRACTURED AT THE TOP. PER THE PHYSICIAN, THE PATIENT'S SEIZURES ARE AT PRE-VNS LEVEL. THE PHYSICIAN BELIEVES THE INCREASE IN SEIZURES WAS DUE TO THE LEAD FRACTURE. FACTORS THAT COULD BE CONTRIBUTING TO THE INCREASE IN SEIZURES INCLUDE THE PATIENT'S OVERALL DIAGNOSIS AND CONDITION OF THEIR EPILEPSY. ONSET OF THE SEIZURES IS (B)(6) 2025. PER THE PHYSICIAN, THE PATIENT HAS NOT EXPERIENCED ANY TRAUMA TO THE SITE, NOR HAS THE PATIENT MANIPULATED THE SITE. PHYSICIAN DOES NOT BELIEVE THERE ARE X-RAYS. THE SURGEON WAS COMFORTABLE TAKING THE PATIENT TO SURGERY BASED OFF THE DIAGNOSTICS. THE SUSPECT DEVICE WAS STATED HAVE BEEN DISCARDED AFTER SURGERY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAS HAD INCREASED SEIZURES OVER THE LAST MONTH. THE PHYSICIAN AND REPRESENTATIVE PERFORMED DIAGNOSTICS WHICH SHOWED HIGH IMPEDANCE >=9000 OHMS AND LOW OUTPUT CURRENT. THE PATIENT SAW NEUROSURGEON WHO PLANNED FOR EXPLORATORY SURGERY TO FIX LEAD/GENERATOR. THE PATIENT LATER UNDERWENT LEAD REVISION. THE SUSPECT DEVICE HAS NOT BEEN RECEIVED TO DATE. NO ADDITIONAL RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    978599 PULSE GEN MODEL 1000 LEAD LYJ LIVANOVA USA, INC. 304-20 812 05425025750139

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR Male Required Intervention