BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 304

    MDR report key: 8874503 · Received August 8, 2019

    Report

    Report Number
    1644487-2019-01530
    Event Type
    Malfunction
    Date Received
    August 8, 2019
    Date of Event
    July 15, 2019
    Report Date
    March 19, 2021
    Manufacturer
    LIVANOVA USA, INC.
    Product Code
    LYJ
    UDI-DI
    05425025750139
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    INFORMATION WAS RECEIVED THAT THE PATIENT UNDERWENT LEAD REVISION SURGERY. THE SUSPECT PRODUCT HAS NOT BEEN RECEIVED TO ANALYSIS TO DATE. NO ADDITIONAL RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Description of Event or Problem · 1

    IT WAS REPORTED BY SALES REPRESENTATIVE THAT WHEN CHECKING TABLETS FOR A UNIVERSITY IT WAS NOTED THAT THERE WAS A PATIENT WITH HIGH LEAD IMPEDANCE. INFORMATION WAS RECEIVED FROM THE SALES REPRESENTATIVE STATING THE PATIENT WAS SENT FOR X-RAYS AND X-RAYS LOOKED OK. X-RAYS WERE NOT AVAILABLE FOR REVIEW. THE PHYSICIAN AND SURGEON DECIDED THEY WOULD NOT CHANGE THE LEAD AND DECIDED TO KEEP THE DEVICE ON AT THE PATIENT'S CURRENT SETTINGS. THE PATIENT WAS STATED TO BE IN AGREEMENT WITH THIS. THE DEVICE HISTORY RECORD'S OF THE LEAD WAS REVIEWED. THE LEAD PASSED FINAL QUALITY AND FUNCTIONAL SPECIFICATIONS PRIOR TO RELEASE. NO SURGICAL INTERVENTION HAS BEEN REPORTED TO DATE. NO ADDITIONAL RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    670228 LEAD MODEL 304 LEAD LYJ LIVANOVA USA, INC. 304-20 204706 05425025750139

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR