BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 304

    MDR report key: 22181655 · Received June 10, 2025

    Report

    Report Number
    1644487-2025-10244
    Event Type
    Malfunction
    Date Received
    June 10, 2025
    Date of Event
    May 16, 2025
    Report Date
    May 20, 2026
    Manufacturer
    HOUSTON
    Product Code
    LYJ
    UDI-DI
    05425025750139
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT HIGH IMPEDANCE WAS SEEN WHEN THEY WENT TO TURN ON THE DEVICE. REPORTEDLY, NORMAL PARAMETERS WERE SEEN DURING THE INITIAL IMPLANT, AND THREE IMPEDANCE TESTS WERE PERFORMED WITHIN NORMAL LIMITS DURING THE SURGERY. X-RAYS WERE TAKEN AFTER THE REPORT OF THE HIGH IMPEDANCE AND SENT TO THE MANUFACTURER FOR REVIEW. AP AND LATERAL CHEST AND NECK X-RAYS WERE RECEIVED AND REVIEWED. THE GENERATOR IS LOCATED THE PATIENT¿S LEFT CHEST. DUE TO THE POOR IMAGE QUALITY COMPLETE CONNECTOR PIN INSERTION AND FEEDTHRU WIRE CONTINUITY COULD NOT BE ASSESSED DUE TO THE QUALITY OF THE IMAGES PROVIDED. THE LEAD WAS UNABLE TO BE ASSESSED DUE TO POOR IMAGE QUALITY. A PORTION OF THE LEAD IS VISIBLE, AND NO GROSS DISCONTINUITIES OR SHARP ANGLES ARE OBSERVED IN THAT PORTION. HOWEVER, MAJORITY OF THE LEAD, STRAIN RELIEF, TIE DOWN PLACEMENT, LEAD WIRES AND LEAD ROUTING ARE UNABLE TO BE ASSESSED DUE TO POOR RESOLUTION QUALITY ON THE IMAGES PROVIDED THE CAUSE OF THE PATIENT¿S HIGH IMPEDANCE COULD NOT BE DETERMINED BASED ON THE IMAGES PROVIDED. NOTE THAT THE PRESENCE OF A MICRO-FRACTURE AND/OR A LEAD DISCONTINUITY COULD NOT BE RULED OUT IN THE PORTION OF THE LEAD THAT IS NOT VISIBLE IN THE PROVIDED IMAGES. PER THE IMPLANTING PHYSICIAN, THE PIN WAS FULLY INSERTED AT THE TIME OF THE IMPLANT. IT WAS VISIBLE PAST THE CONNECTOR BLOCK, AND THE SETSCREW CLICKS WERE CONFIRMED DURING THE PROCEDURE. THERE WAS NO REPORTED TRAUMA TO THE LEAD OR GENERATOR SITE BETWEEN THE DATE OF IMPLANT AND THE FIRST OBSERVATION OF HIGH IMPEDANCE. NO SURGICAL INTERVENTION HAS OCCURRED TO DATE. NO ADDITIONAL RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Description of Event or Problem · 0

    LATER, IT WAS REPORTED THAT THE DEVICE WAS EXPLANTED. HOWEVER, IT WAS NOTED THAT THE SYSTEM WAS REVISED IN-BETWEEN THE DATE OF IMPLANT AND DATE, NO PRODUCTS WERE REPLACED. NO ADDITIONAL DETAILS WERE PROVIDED ON THIS REVISION SURGERY. THE PATIENT'S GENERATOR WAS EXPLANTED AT THE PATIENT'S REQUEST ON. IT WAS NOTED THAT PRIOR TO EXPLANT, THE IMPEDANCE WAS NORMAL @ 1797 OHMS. THE SUSPECT PRODUCT REMAINS IMPLANTED AT THIS TIME. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    433190 LEAD MODEL 304 LEAD LYJ HOUSTON 304-20 7987 05425025750139

    Patients

    Seq Age Sex Outcome Treatment
    1