BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 304

    MDR report key: 18283597 · Received December 7, 2023

    Report

    Report Number
    1644487-2023-01750
    Event Type
    Malfunction
    Date Received
    December 7, 2023
    Date of Event
    November 7, 2022
    Report Date
    March 13, 2024
    Manufacturer
    LIVANOVA USA, INC.
    Product Code
    LYJ
    UDI-DI
    05425025750139
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDICAL DEVICE PROBLEM :A072102.

    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

    THE SUSPECT DEVICE WAS RETURNED AND RECEIVED INTO PRODUCT ANALYSIS FOR DEVICE TESTING. TESTING HAS NOT BEEN COMPLETED TO DATE. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Description of Event or Problem · 0

    DEVICE EVALUATION WAS COMPLETED ON THE RETURNED DEVICES. HIGH IMPEDANCE WAS OBSERVED SOONER THAN PREVIOUSLY REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAS HIGH IMPEDANCE. IMAGING ALSO REVEALED A POSSIBLE FRACTURE. IT WAS NOTED THAT THE PATIENT WAS HAVING GRAND MAL SEIZURES AND UP UNTIL THAT TIME HE HAD BEEN SEIZURE FREE SINCE HIS IMPLANT WITH ONLY OCCASIONAL ABSENCE SEIZURES. DEVICE HISTORY RECORDS WERE REVIEWED FOR THE LEAD AND SHOWED THE DEVICE PASSED ALL SPECIFICATIONS PRIOR TO DISTRIBUTION. THE PATIENT UNDERWENT A FULL REPLACEMENT. THE EXPLANTED DEVICES HAVE NOT BEEN RECEIVED TO ANALYSIS TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222231 LEAD MODEL 304 LEAD LYJ LIVANOVA USA, INC. 304-20 204419 05425025750139

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR Male Required Intervention