BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 15694564 · Received October 29, 2022

    Report

    Report Number
    1644487-2022-01348
    Event Type
    Malfunction
    Date Received
    October 29, 2022
    Date of Event
    January 4, 2022
    Report Date
    April 10, 2023
    Manufacturer
    LIVANOVA USA, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    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 THE PATIENT IS EXPERIENCING HIGH IMPEDANCE AND INCREASED SEIZURES. NO KNOWN SURGICAL INTERVENTION HAS OCCURRED TO DATE. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Description of Event or Problem · 0

    AP CHEST, AP NECK, LATERAL CHEST, AND LATERAL NECK X-RAYS WERE REVIEWED. BASED ON THE CONTRAST OF THE IMAGE AT THE CONNECTOR BLOCK, LEAD PIN INSERTION CANNOT BE CONFIRMED. BOTH FEEDTHROUGH WIRES APPEAR INTACT. THERE IS STRAIN RELIEF PRESENT AND IT IS PLACED PER LABELING. TWO TIE DOWNS ARE SEEN BUT ARE NOT PLACED PER LABELING, THEY ARE PLACED AT THE TOP OF THE STRAIN RELIEF LOOP. NONE OF THE LEAD CAN BE VISUALIZED BEHIND THE GENERATOR. NO SHARP ANGLES WERE SEEN. THERE APPEARS TO BE A GROSS FRACTURE OF THE LEAD AT THE CONNECTOR PIN AS NO LEAD CAN BE SEEN TRAVELING FROM THE PIN AND ANOTHER DISCONTINUITY CAN BE SEEN NEARBY AS THE LEAD NEARLY COMPLETES A FIGURE 8. OF NOTE, THERE IS A PREVIOUS LEAD WIRE PRESENT WITH ELECTRODES STILL ATTACHED TO THE VAGUS NERVE WITH REMAINING WIRE THAT WAS CUT AT A LENGTH > 2CM. BASED ON THE X-RAYS RECEIVED, THE CAUSE OF THE HIGH IMPEDANCE COULD BE CAUSED FROM THE POTENTIAL DISCONTINUITY OF THE LEAD AT THE CONNECTOR PIN; HOWEVER, THIS CANNOT BE CONFIRMED DUE TO THE IMAGES PROVIDED. ANY FRACTURES OR MICROFRACTURES ON THE PORTIONS OF THE LEAD THAT WERE NOT VISIBLE CANNOT BE RULED OUT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD FULL REVISION SURGERY. THE REP ONSITE RETRIEVED THE GENERATOR BUT NOT THE LEAD, STATING THE LEAD WENT TO PATHOLOGY. PATHOLOGY WAS UNABLE TO LOCATE THE LEAD AND IT WAS CONCLUDED THAT THE LEAD WAS LIKELY DISCARDED. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2880589 LEAD MODEL 302 LEAD LYJ LIVANOVA USA, INC. 302-20 2239

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Female Other