BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 1000

    MDR report key: 21284450 · Received January 31, 2025

    Report

    Report Number
    1644487-2025-00098
    Event Type
    Injury
    Date Received
    January 31, 2025
    Date of Event
    December 31, 2024
    Report Date
    January 31, 2025
    Manufacturer
    CYBERONICS - HOUSTON
    Product Code
    LYJ
    UDI-DI
    05425025750405
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    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 WAS HOSPITALIZED DUE TO AN INCREASE IN SEIZURES. PATIENT REPORTEDLY HAS AN INFECTION NOT RELATED TO VNS. THE PATIENTS VNS WAS INTERROGATED AND SHOWED BATTER LIFE IS NEOS AND SYSTEM DIAGNOSTICS WERE WITHIN NORMAL LIMITS. PATIENT WAS REFERRED FOR A BATTERY REPLACEMENT. THE PHYSICIAN HAS RESPONDED THAT THE CAUSE OF THE INCREASE IN SEIZURES IS DUE TO DEPLETED BATTERY (NORMAL EOS, 0% BATTERY) AND OTHER "INTRACTABLE". THE SEIZURE LEVEL RISE WAS ABOVE PRE-VNS BASELINE LEVELS. THE PHYSICIAN'S RESPONSE THAT THE DEVICE WAS COMPLETELY DEPLETED (0% BATTERY REMAINING) CONTRADICTS THE INITIAL REPORT OF 0-8% NEOS. THE INITIAL REPORTER WAS CONTACTED TO CLARIFY THE DISCREPANCY. HE CONFIRMED THE DEVICE WAS NOT AT EOS (0%) THAT IT DID INDEED HAVE 0-8% REMAINING AT TIME OF INTERROGATION ONE WEEK AFTER THE SEIZURE HOSPITALIZATION. THE PATIENT LATER HAD A BATTERY REPLACEMENT DUE TO BATTERY DEPLETION. THE EXPLANTED DEVICE HAS NOT BEEN RECEIVED TO DATE. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    519503 PULSE GEN MODEL 1000 GENERATOR LYJ CYBERONICS - HOUSTON 1000 204236 05425025750405

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Male Required Intervention| H