BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 12869226 · Received November 24, 2021

    Report

    Report Number
    1644487-2021-01650
    Event Type
    Malfunction
    Date Received
    November 24, 2021
    Date of Event
    November 2, 2021
    Report Date
    May 20, 2022
    Manufacturer
    LIVANOVA USA, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B5 DESCRIBE EVENT OR PROBLEM, CORRECTED DATA: INITIAL REPORT INADVERTENTLY DID NOT INCLUDE INFORMATION FROM THE IMPLANT FORM. B6 RELEVANT TESTS/LABORATORY DATA, CORRECTED DATA: INITIAL REPORT INADVERTENTLY DID NOT INCLUDE DIAGNOSTICS FROM THE DATE OF SURGERY. D6B IF EXPLANTED, GIVE DATE, CORRECTED DATA: INITIAL REPORT INADVERTENTLY DID NOT INCLUDE EXPLANT DATE. F10 HEALTH EFFECT ¿ IMPACT CODE, CORRECTED DATA: INITIAL REPORT INADVERTENTLY DID NOT INCLUDE CODE ¿F1905¿ F10 HEALTH EFFECT ¿ MEDICAL DEVICE CODE, CORRECTED DATA: INITIAL REPORT INADVERTENTLY DID NOT INCLUDE CODE ¿A040101¿ H6 TYPE OF INVESTIGATION, CORRECTED DATA: INITIAL REPORT INADVERTENTLY DID NOT INCLUDE CODE ¿B17¿ H6 INVESTIGATION FINDINGS, CORRECTED DATA: INITIAL REPORT INADVERTENTLY DID NOT INCLUDE CODE ¿C070603¿.

    Description of Event or Problem · 0

    THE PATIENT UNDERWENT FULL REVISION SURGERY. THE IMPLANT FORM LISTED THAT HIGH IMPEDANCE WAS SEEN AS WELL. THE SUSPECT DEVICE HAS NOT BEEN RECEIVED BY THE MANUFACTURER TO DATE. NO ADDITIONAL RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Description of Event or Problem · 0

    THE EXPLANTED DEVICE WAS DISCARDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT'S VNS SHOWED LOW IMPEDANCE. THE PATIENT HAS BEEN REFERRED FOR FULL REVISION SURGERY.. NO KNOWN RELEVANT SURGICAL INTERVENTION HAS OCCURRED TO DATE. NO ADDITIONAL RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1764702 LEAD MODEL 302 LEAD LYJ LIVANOVA USA, INC. 302-20 2107

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Female