BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 1000

    MDR report key: 16962364 · Received May 19, 2023

    Report

    Report Number
    1644487-2023-00609
    Event Type
    Malfunction
    Date Received
    May 19, 2023
    Date of Event
    April 24, 2023
    Report Date
    August 1, 2024
    Manufacturer
    LIVANOVA USA, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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.

    Additional Manufacturer Narrative · 0

    CORRECTIONS FOR SUPPLEMENTAL REPORT #1: D1. LEAD MODEL 304. D2. TYPE OF DEVICE NAME: LEAD. F10. HEALTH EFFECT - CLINICAL CODE: E210401.

    Description of Event or Problem · 0

    PATIENT WAS REFERRED FOR BATTERY REPLACEMENT SURGERY DUE TO LOW BATTERY AND PAINFUL STIMULATION IN THE NECK. THE PAINFUL STIMULATION OCCURRED AFTER AN INCREASE IN SETTINGS, WHICH WAS THEN LOWERED. THE PAIN WAS BETTER BUT STILL NOT AS COMFORTABLE AS BEFORE. PATIENT ALSO EXPERIENCED AN INCREASE IN SEIZURES AND MUSCLES SPASMS IN THE NECK. NO KNOWN RELEVANT SURGICAL INTERVENTION HAS OCCURRED TO DATE. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A FULL REVISION SURGERY DUE TO PROPHYLACTIC REPLACEMENT OF THE GENERATOR AND HIGH LEAD IMPEDANCE. THE EXPLANTED DEVICES HAVE 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
    622347 PULSE GEN MODEL 1000 LEAD MODEL 304 LYJ LIVANOVA USA, INC. 304-20 204567

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Male Other