BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEAD MODEL 304

    MDR report key: 17321814 · Received July 13, 2023

    Report

    Report Number
    1644487-2023-00908
    Event Type
    Injury
    Date Received
    July 13, 2023
    Date of Event
    June 20, 2023
    Report Date
    January 2, 2024
    Manufacturer
    LIVANOVA USA, INC.
    Product Code
    LYJ
    UDI-DI
    05425025750153
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SUPPLEMENTAL REPORT 1: ADVERSE EVENT PROBLEM: HEALTH EFFECT - IMPACT CODE: F1905. ADVERSE EVENT PROBLEM CODES: TYPE OF INVESTIGATION: B17. SUPPLEMENTAL REPORT 2: DEVICE AVAILABLE FOR EVALUATION?: YES. IF YES, RETURNED TO MANUFACTURER ON (MO/DAY/YR): 10/24/2023.

    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

    PRODUCT ANALYSIS WAS COMPLETED ON THE RETURNED LEAD. CONTINUITY CHECKS OF THE RETURNED LEAD PORTION WERE PERFORMED DURING THE FUNCTIONAL ANALYSIS, AND NO DISCONTINUITIES WERE IDENTIFIED. THE CONDITION OF THE RETURNED LEAD PORTIONS IS CONSISTENT WITH CONDITIONS THAT TYPICALLY EXIST FOLLOWING AN EXPLANT PROCEDURE. OTHER THAN TYPICAL WEAR AND EXPLANT RELATED OBSERVATIONS, NO ANOMALIES WERE IDENTIFIED IN THE RETURNED LEAD PORTION. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Description of Event or Problem · 0

    LEAD REVISION WAS PERFORMED AS THE SURGEON THOUGHT THAT A 2MM LEAD WOULD BE BETTER FOR THE PATIENT. NO ADVERSE CONDITIONS ON THE LEAD WERE FOUND AT EXPLANT. EXPLANTED LEAD HAS NOT BEEN RECEIVED TO DATE. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Description of Event or Problem · 0

    THE EXPLANTED LEAD WAS RETURNED AND RECEIVED. PRODUCT ANALYSIS HAS NOT YET BEEN PERFORMED ON THE DEVICE. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Description of Event or Problem · 0

    PATIENT IS SCHEDULED FOR EXPLORATORY SURGERY OF THE NECK AND POSSIBLE REVISION OF THE LEAD DUE TO SPASMS THE PATIENT EXPERIENCES WITH DEVICE STIMULATION. THE PATIENT'S PHYSICIAN NOTES THAT THE PATIENT HAS MET WITH AN ENT, PHYSICAL MEDICINE & REHAB SPECIALIST AS WELL AS REDUCED THE PATIENT'S SETTINGS AND NO ONE CAN PINPOINT WHAT IS CAUSING THE SPASMS. NO KNOWN RELEVANT SURGICAL INTERVENTION HAS OCCURRED TO DATE. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    766448 LEAD MODEL 304 LEAD LYJ LIVANOVA USA, INC. 304-30 205515 05425025750153

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Female Other