BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 106

    MDR report key: 21574754 · Received March 11, 2025

    Report

    Report Number
    1644487-2025-00270
    Event Type
    Injury
    Date Received
    March 11, 2025
    Date of Event
    November 1, 2024
    Report Date
    June 25, 2025
    Manufacturer
    CYBERONICS - HOUSTON
    Product Code
    LYJ
    UDI-DI
    05425025750061
    PMA / PMN Number
    P970003
    Adverse Event
    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

    THE DEVICE HAS BEEN RECEIVED BY MANUFACTURE AND PRODUCT ANALYSIS WAS PERFORMED. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Description of Event or Problem · 0

    IT WAS LATER REPORTED THAT THE HOSPITALIZATION FOR THE PATIENT IS NOT ABNORMAL. IT ONLY BECAME MORE FREQUENT IN (B)(6) 2024 WHEN DEVICE WAS AT NEAR END OF SERVICE. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAS BEEN HOSPITALIZED ON MULTIPLE OCCASIONS DUE TO INCREASE IN SEIZURES BEGINNING IN (B)(6) 2023. THE GENERATOR WAS AT INTENSE FOLLOW UP INDICATOR (IFI) (5-11%) IN (B)(6) 2024 SETTINGS WERE LOWERED TO ALLOW THE BATTERY TO LAST. IN NOVEMBER 2024 GENERATOR WAS AT NEAR END OF SERVICE (NEOS (0-5%). THE DEVICE WAS TURNED OFF IN (B)(6) 2025. THERE WAS NO INDICATION OF DEVICE MALFUNCTION BUT PROVIDER WAS CONCERNED AS THE INCREASED SEIZURES BEGAN BEFORE NEOS AND BEFORE THE DISABLEMENT. THE DEVICE WAS REPLACED IN (B)(6) 2025 DUE TO BATTERY DEPLETION. IT WAS LATER REPORTED THAT THE PROVIDER BELIEVED THAT THE LOW BATTERY WAS CONTRIBUTING TO THE INCREASE IN SEIZURE. PROVIDER ALSO STATED THAT THE PATIENT IS EXPERIENCING STATUS EPILEPTICUS ON A MONTHLY BASIS. DEVICE HISTORY RECORDS WERE REVIEWED. THE DEVICE PASSED ALL FUNCTIONAL SPECIFICATIONS AND QUALITY TESTS AND WERE STERILIZED PRIOR TO DISTRIBUTION. DEVICE HAS BEEN EXPLANTED AND RETURNED TO MANUFACTURE BUT HAS NOT BEEN RECEIVED TO DATE. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Description of Event or Problem · 0

    SETTINGS FOR THE SUSPECTED GENERATOR WAS PROVIDED. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    336556 PULSE GEN MODEL 106 GENERATOR LYJ CYBERONICS - HOUSTON 106 204952 05425025750061

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Unknown Required Intervention| H