BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 17086365 · Received June 8, 2023

    Report

    Report Number
    1644487-2023-00727
    Event Type
    Malfunction
    Date Received
    June 8, 2023
    Date of Event
    May 16, 2023
    Report Date
    June 8, 2023
    Manufacturer
    CYBERONICS - HOUSTON
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 LIVANOVAS 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 IN PRE-OP FOR A BATTERY REPLACEMENT SURGERY, THE PATIENT¿S GENERATOR WAS COMPLETELY DEPLETED AND UNABLE TO BE INTERROGATED. THE BATTERY WAS REPLACED, AND HIGH IMPEDANCE WAS SEEN. TROUBLESHOOTING WAS PERFORMED USING A TEST RESISTOR WITH THE NEW GENERATOR, AND THERE WAS NO HIGH IMPEDANCE, INDICATING THE HIGH IMPEDANCE WAS LIKELY RELATED TO THE LEAD. THE SURGEON THEN FOUND A SMALL TEAR ON THE LEAD. THE PATIENT WAS REFERRED FOR A LEAD REVISION AT A LATER DATE. NO OTHER KNOWN 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
    274916 LEAD MODEL 302 LEAD LYJ CYBERONICS - HOUSTON 302-20 201306

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Male