BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 1000

    MDR report key: 21608460 · Received March 14, 2025

    Report

    Report Number
    1644487-2025-00291
    Event Type
    Injury
    Date Received
    March 14, 2025
    Date of Event
    January 2, 2023
    Report Date
    January 8, 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
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS EVENT IS ASSOCIATED WITH CAPA CA-0049 REGARDING PREVIOUSLY UNREPORTED COMPLAINTS FROM BRAZIL. F10 HEALTH EFFECT, CLINICAL CODE: CODE E2402 UTILIZED; APPROPRIATE TERM ¿EDEMA¿ IS NOT AVAILABLE. A2. AGE AT TIME OF EVENT; CORRECTED INFORMATION; INITIAL MDR INADVERTENTLY LISTED INCORRECT AGE. B3. DATE OF EVENT; CORRECTED INFORMATION; INITIAL MDR INADVERTENTLY LISTED INCORRECT DATE. B5. DESCRIBE EVENT; CORRECTED INFORMATION; INITIAL MDR INADVERTENTLY OMITTED INFORMATION. G3. DATE RECEIVED BY MANUFACTURER; CORRECTED INFORMATION; INITIAL MDR INADVERTENTLY LISTED INCORRECT DATE. H6. ADVERSE EVENT PROBLEM CODES; CORRECTED INFORMATION; INITIAL MDR INADVERTENTLY OMITTED CODES.

    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

    UPDATE WAS RECEIVED FROM THE PATIENT'S MOTHER. FOLLOWING GENERATOR REPLACEMENT SURGERY, THE PATIENT EXPERIENCED PAIN AND SWELLING IN THE BREAST AND WAS PRESCRIBED MEDICATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAS BEEN HOSPITALIZED DUE TO SEVERE ANEMIA AND A URINARY TRACT INFECTION AND REQUIRES CONSTANT OXYGEN DUE TO A GENETIC CONDITION THAT AFFECTS SEVERAL BODILY TISSUES. THE PATIENT'S CAREGIVER STATES THAT VNS IS NOT HOLDING BACK SEIZURES AND BELIEVES THE GENERATOR MAY NEED TO BE REPLACED. THE SEIZURES ARE 'DESPERATE' AND OCCUR IN LARGE NUMBERS AND VNS WAS ADJUSTED, BUT MANY SEIZURES OCCURRED AND WERE SEVERE. THE PHYSICIAN ALTERED THE PATIENT'S MEDICATIONS THAT WERE BEING USED TO TREAT THEIR INFECTION BUT FEELS THAT VNS IS NOT 'PULLING' MUCH AND IS CONCERNED THAT IF THE PATIENT HAS ANOTHER INFECTION, THE PATIENT WILL BE WITHOUT SUPPORT. THE PATIENT IS CURRENTLY DOING WELL BUT IS NOTED TO CONTINUE TO HAVE DAILY SEIZURES, SUGGESTED TO POSSIBLY BE RELATED TO VNS. A REVIEW OF DEVICE HISTORY RECORDS SHOWED THAT BOTH THE GENERATOR PASSED QUALITY CONTROL INSPECTION AND WAS STERILIZED PRIOR TO DISTRIBUTION. NO SURGICAL INTERVENTION HAS BEEN REPORTED TO DATE. NO ADDITIONAL RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    926074 PULSE GEN MODEL 1000 GENERATOR LYJ LIVANOVA USA, INC. 1000 7389 05425025750405

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Female Hospitalization| R