BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 303

    MDR report key: 11898341 · Received May 27, 2021

    Report

    Report Number
    1644487-2021-00727
    Event Type
    Malfunction
    Date Received
    May 27, 2021
    Date of Event
    March 18, 2021
    Report Date
    November 23, 2021
    Manufacturer
    LIVANOVA USA, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    F10. CORRECTED DATA, INITIAL REPORT: INADVERTENTLY USED CODE A040101 INSTEAD OF A072201H6. CORRECTED DATA, INITIAL REPORT: INADVERTENTLY USED CODES FOR FRACTURE RATHER THAN FOR HIGH IMPEDANCE.

    Description of Event or Problem · 1

    THE PATIENT'S GENERATOR AND LEAD WERE REPLACED DUE TO HIGH IMPEDANCE. THE EXPLANTED PRODUCTS HAVE NOT BEEN RECEIVED TO DATE. THE DEVICE HISTORY RECORDS OF THE LEAD WERE REVIEWED. THE LEAD PASSED FINAL QUALITY AND FUNCTIONAL SPECIFICATIONS PRIOR TO RELEASE. NO FURTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    790386 LEAD MODEL 303 LEAD LYJ LIVANOVA USA, INC. 303-20 2873

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Male