BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 1000

    MDR report key: 21801893 · Received April 8, 2025

    Report

    Report Number
    1644487-2025-00377
    Event Type
    Injury
    Date Received
    April 8, 2025
    Date of Event
    March 14, 2025
    Report Date
    February 13, 2026
    Manufacturer
    LIVANOVA USA, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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 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. F10 HEALTH EFFECT, CLINICAL CODE: CODE E2402 UTILIZED; APPROPRIATE TERM ¿PROTRUSION¿ IS NOT AVAILABLE. H3. CODE 81 - DEVICE EVALUATION IS NOT NECESSARY BECAUSE THE REPORTED EVENT HAS BEEN DETERMINED AS NOT RELATED TO VNS THERAPY.

    Additional Manufacturer Narrative · 0

    H6, CORRECTED DATA: INITIAL REPORT INADVERTENTLY USED F1905 INSTEAD OF F1903. THE SUPPLEMENTAL REPORT 1 ALSO INADVERTENTLY DID NOT UPDATE THE CONCLUSION CODE TO REFLECT THAT THE REPORTED INFECTION WAS RELATED TO SURGERY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD A POCKET REVISION AND HAD THEIR DEVICE RELOCATED AS THE GENERATOR WAS VERY CLOSE TO SURFACE OF SKIN. THE DEVICE IS NOTABLY NOT EXTRUDED, BUT THE PATIENT HAS A RED SPOT, AND DUE TO THE PROXIMITY OF THE SKIN SURFACE, IT IS STATED THERE IS A POSSIBILITY OF THE DEVICE EXTRUDING AT SOME POINT. A REVIEW OF DEVICE HISTORY RECORDS SHOWED THAT THE GENERATOR PASSED QUALITY CONTROL INSPECTION AND WAS STERILIZED PRIOR TO DISTRIBUTION. NO ADDITIONAL RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Description of Event or Problem · 0

    IT WAS FURTHER REPORTED THAT THE PATIENT WAS FULLY EXPLANTED DUE TO INFECTION AFTER PRIOR REPOSITIONING. PER THE REPORT, A SPOT APPEARED IN THE PATIENTS ARMPIT AND WHEN THE DEVICE POCKET WAS TESTED, IT WAS FOUND TO BE INFECTED. THE PHYSICIAN REMOVED BOTH THE GENERATOR AND LEAD AND WILL WAIT TO DETERMINE IF THEY WILL RE-IMPLANT. PRODUCT EVALUATION IS NOT NECESSARY AS THE EVENT IS NOT RELATED TO VNS THERAPY.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE CAUSE OF PROTRUSION WAS RELATED TO THE REPORTED INFECTION AND SURGERY OCCURRED DUE TO OR TO PRECLUDE SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1581153 PULSE GEN MODEL 1000 GENERATOR LYJ LIVANOVA USA, INC. 1000 7679

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR Male Required Intervention