BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL UNKNOWN

    MDR report key: 21067675 · Received January 3, 2025

    Report

    Report Number
    1644487-2025-00004
    Event Type
    Malfunction
    Date Received
    January 3, 2025
    Date of Event
    December 11, 2024
    Report Date
    February 28, 2025
    Manufacturer
    LIVANOVA USA, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    F10 HEALTH EFFECT, CLINICAL CODE: CODE E2402 UTILIZED; APPROPRIATE TERM ¿VOICE ALTERATION¿ IS NOT AVAILABLE. 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. HEALTH EFFECT - CLINICAL CODE: E210401. HEALTH EFFECT - CLINICAL CODE: E0717.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE PHYSICIAN. PER THE PHYSICIAN, THE CAUSE OF THE PATIENT'S COUGH, VOICE ALTERATION, PAINFUL STIMULATION AND DYSPNEA WAS NOT KNOWN. THE PATIENT HAS NOT EXPERIENCED ANY RECENT TRAUMA OR MANIPULATION. THE PATIENT DID HAVE X-RAYS TAKEN FOR THE HIGH IMPEDANCE HOWEVER THE IMAGES WERE NOT PROVIDED FOR REVIEW. NO KNOWN INTERVENTION HAS OCCURRED FOR THE HIGH IMPEDANCE. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN THE PATIENT'S GENERATOR WAS INTERROGATED IN PRE-OP, THE DEVICE WAS AT 0% BATTERY, THERAPY WAS DISABLED AND THE LEAD IMPEDANCE WAS UNABLE TO BE READ. WHEN THE DEVICE WAS PROGRAMMED TO 1MA SO A SYSTEM DIAGNOSTICS TEST COULD BE PERFORMED, THE PATIENT BEGAN TO EXPERIENCE AN INTENSE COUGH, DISCOMFORT, DIFFICULTY BREATHING AND DIFFICULTY SPEAKING. THIS PERSISTED EVEN AFTER THE OUTPUT CURRENT WAS TURNED DOWN TO 0.25MA BUT RESOLVED ONCE THE GENERATOR WAS PROGRAMMED TO 0MA. IT WAS NOTED THE SURGEON WAS AWARE FOR THE POTENTIAL OF A LEAD REVISION DUE TO THESE EVENTS. IN THE OPERATING ROOM, HIGH IMPEDANCE WAS SEEN WHEN THE LEAD WAS CONNECTED TO THE NEWLY IMPLANTED GENERATOR. THE GENERATOR WAS LEFT OFF AND THE SURGEON NOTED THEY WOULD DISCUSS A LEAD REVISION WITH THE PATIENT; THE PATIENT HAD PREVIOUSLY REFUSED THE REVISION IN THE PAST. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    639347 LEAD MODEL UNKNOWN LEAD LYJ LIVANOVA USA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Male Other