BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEAD MODEL 302

    MDR report key: 17143322 · Received June 16, 2023

    Report

    Report Number
    1644487-2023-00776
    Event Type
    Injury
    Date Received
    June 16, 2023
    Date of Event
    May 24, 2023
    Report Date
    July 10, 2023
    Manufacturer
    LIVANOVA USA, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B5. DESCRIBE EVENT; CORRECTED INFORMATION ; INITIAL MDR INADVERTENTLY OMITTED INFORMATION KNOWN PRIOR TO SUBMISSION

    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 SURGICAL REFERRAL MADE FOR THE PAIN, INCREASED SEIZURES REPORTED, AND THERE IS A BUMP BELOW WHERE BOTTOM PART OF GENERATOR. THIS WAS REPORTED VIA CLINIC NOTES. FOLLOW UP WAS PERFORMED WITH THE SURGEON IN WHICH IT WAS DISCOVERED THAT NO LEAD PROTRUSION (BUMP) WAS NOTED BY THE SURGEON. THEY STATED THAT THE CAUSE OF THE PAIN, WAS A RESULT OF PATIENT PHYSIOLOGY. THEY STATED THAT THE PATIENT WAS TO UNDERGO A FULL REVISION WITH NEWER SINGLE LEAD DEVICE AS BATTERY IS LOW. ANOTHER SURGICAL CONSULT WAS HAD IN WHICH THE SURGEON CALLED OFF THE SURGERY AND DEEMED IT UNNECESSARY. HE STATED THAT EVERYTHING WAS FINE AND NO SURGERY WAS NEEDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT'S LEAD IS SEEN PROTRUDING UNDERNEATH THE PATIENT'S SKIN (IN THEIR NECK) AND CAUSING THEM PAIN. THE DEVICE'S SETTINGS WERE REDUCED IN HOPE THIS WOULD REDUCE THE PAIN AND LESSEN THE PROTRUSION. IMPEDANCE WAS REPORTED TO BE FINE. X-RAYS WERE REFERRED FOR THIS PATIENT. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    435426 LEAD MODEL 302 LEAD LYJ LIVANOVA USA, INC. 302-20 009441

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Female