BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEAD MODEL 304

    MDR report key: 17221063 · Received June 28, 2023

    Report

    Report Number
    1644487-2023-00829
    Event Type
    Injury
    Date Received
    June 28, 2023
    Date of Event
    June 3, 2023
    Report Date
    August 18, 2023
    Manufacturer
    LIVANOVA USA, INC.
    Product Code
    LYJ
    UDI-DI
    05425025750139
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D. SUSPECT MEDICAL DEVICE; CORRECTED INFORMATION; INITIAL MDR INADVERTENTLY USED THE INCORRECT SUSPECT DEVICE H4. DEVICE MANUFACTURE DATE; CORRECTED INFORMATION; INITIAL MDR INADVERTENTLY USED THE INCORRECT SUSPECT DEVICE.

    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. F10 CODE E2402 USED: PROPOSED SECOND LEVEL CODING - PROTRUSION TO CAPTURE INCIDENTS OF A DEVICE BEING VISIBLE UNDER THE SKIN.

    Description of Event or Problem · 0

    INFORMATION WAS RECEIVED THAT THE PATIENT HAD THEIR VNS EXPLANTED. NO INFORMATION WAS PROVIDED ON WHAT WAS EXPLANTED; HOWEVER IT WAS PREVIOUSLY NOTED THAT THE PATIENT EXPRESSED A DESIRE TO HAVE THEIR FULL SYSTEM EXPLANTED. THE EXPLANTED PRODUCTS HAVE NOT BEEN RECEIVED TO DATE. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS REFERRED FOR EXPLANT SURGERY DUE TO A SHORTNESS OF BREATH AND AN OBSERVED LUMP, THE VNS WAS ALSO DISABLED. FURTHER INFORMATION WAS RECEIVED, REPORTING THAT THE SURGEON INCORRECTLY PLACED THE LEAD RESULTING IN COMPLICATION OF A LUMP BEING OBSERVED IN THEIR NECK. DUE TO THE PLACEMENT OF THE LEADS, THE PATIENT ALSO EXPERIENCED PAIN. THE PATIENT FELT BETTER WITH THEIR VNS OFF AND ELECTED TO FULLY EXPLANT THE VNS. NO KNOWN RELEVANT 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
    1571481 LEAD MODEL 304 LEAD LYJ LIVANOVA USA, INC. 304-20 7365 05425025750139

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Female Required Intervention| O