BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 304

    MDR report key: 17234813 · Received June 29, 2023

    Report

    Report Number
    1644487-2023-00841
    Event Type
    Malfunction
    Date Received
    June 29, 2023
    Date of Event
    June 5, 2023
    Report Date
    June 29, 2023
    Manufacturer
    CYBERONICS - HOUSTON
    Product Code
    LYJ
    UDI-DI
    05425025750139
    PMA / PMN Number
    P970003
    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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A FULL SYSTEM REVISION DUE TO AN OBSERVED HIGH IMPEDANCE. THE PATIENT WAS INITIALLY REFERRED FOR A GENERATOR REPLACEMENT AS THE DEVICE DISABLED DUE TO THE BATTERY BEING DEPLETED. DURING PRE-OPERATIVE PREPARATIONS, HIGH IMPEDANCE WAS OBSERVED AFTER THE THERAPY WAS RE-ENABLED FOR THE GENERATOR. WHEN THE NEW GENERATOR WAS REPLACED, HIGH IMPEDANCE WAS STILL OBSERVED. THE LEAD PIN WAS REMOVED FOR INSPECTION, AND THE SURGEON IDENTIFIED THAT THE OUTER INSULATION OF THE LEAD WAS SPLINTERED; IT WAS CONCLUDED THAT THE HIGH IMPEDANCE WAS DUE TO THE SPLINTERED LEAD. THE LEAD WAS REPLACED AND AFTER THE REVISION, DIAGNOSTICS WERE WITHIN NORMAL LIMITS. IT WAS NOTED THAT THE EXPLANTED PRODUCTS ARE NOT AVAILABLE FOR RETURN. NO ADDITIONAL OR RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1002107 LEAD MODEL 304 LEAD LYJ CYBERONICS - HOUSTON 304-20 4747 05425025750139

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Male