BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 304

    MDR report key: 17234866 · Received June 30, 2023

    Report

    Report Number
    1644487-2023-00843
    Event Type
    Malfunction
    Date Received
    June 30, 2023
    Date of Event
    October 21, 2022
    Report Date
    June 29, 2023
    Manufacturer
    CYBERONICS - HOUSTON
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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

    AN EXPLANTED GENERATOR AND LEAD WERE RETURNED TO MANUFACTURING. THE RETURNED PRODUCTS UNDERWENT PRODUCT ANALYSIS. THE GENERATORS PROGRAMMING DATA WAS REVIEWED, AND A HIGH IMPEDANCE READING WAS OBSERVED WHILE THE GENERATOR WAS STILL IMPLANTED. PRODUCT ANALYSIS WAS APPROVED FOR THE RETURNED GENERATOR. THE ELECTRICAL TESTS PERFORMED IN THE PA LAB FOUND THAT THE GENERATOR WAS AT INTENSIFIED FOLLOW UP INDICATOR (IFI = NO) CONDITION. THE DEVICE OUTPUT SIGNAL WAS MONITORED FOR MORE THAN 24-HRS AND A COMPREHENSIVE AUTOMATED ELECTRICAL EVALUATION WAS PERFORMED. NO ANOMALIES WERE SEEN, AND THE DEVICE PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS. PRODUCT ANALYSIS WAS APPROVED FOR THE RETURNED LEAD. INCISIONS WERE MADE POST DECONTAMINATION TO ALLOW FOR CONTINUITY CHECKS. NO DISCONTINUITIES WERE IDENTIFIED. THE CONDITION OF THE RETURNED LEAD PORTION IS CONSISTENT WITH CONDITIONS THAT TYPICALLY EXIST FOLLOWING AN EXPLANT PROCEDURE. ONE PORTION OF THE LEAD ASSEMBLY WAS RETURNED. THE TIE DOWNS AND ELECTRODE ARRAY WERE NOT RETURNED; THEREFORE, EVALUATION AND COMMENTARY WERE NOT MADE ON THOSE PORTIONS OF THE LEAD. TWO SETS OF SET SETSCREW MARKS WERE OBSERVED ON THE CONNECTOR PIN. THE MARKS PROVIDE EVIDENCE OF A PROPER MECHANICAL CONTACT BETWEEN CONDUCTIVE SURFACES OF BOTH THE GENERATOR AND CONNECTOR PIN, THEREBY ENSURING A GOOD ELECTRICAL CONNECTION TO THE LEAD AT ONE POINT IN TIME. THERE WAS A SLICE CUT ON THE CONNECTOR BOOT WHICH PENETRATED TO PIN INNER TUBE AND COIL. ABRASIONS WERE OBSERVED IN VARIOUS LOCATIONS, POSSIBLY CAUSED BY WEAR. THERE WERE DRIED REMNANTS OF WHAT ONCE MAY HAVE BEEN BODY FLUIDS INSIDE THE INNER TUBING; HOWEVER, THERE IS NO OBVIOUS PATH OF FLUID INGRESS OTHER THAN THE IDENTIFIED OPENING AND CUT ENDS. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1002120 LEAD MODEL 304 LEAD LYJ CYBERONICS - HOUSTON 304-20 203077

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Male