BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 11140050 · Received January 8, 2021

    Report

    Report Number
    1644487-2021-00035
    Event Type
    Malfunction
    Date Received
    January 8, 2021
    Date of Event
    December 14, 2020
    Report Date
    August 5, 2021
    Manufacturer
    LIVANOVA USA, INC.
    Product Code
    MUZ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 0

    PATIENT UNDERWENT FULL REVISION SURGERY. THE EXPLANTED PRODUCTS HAVE NOT BEEN RECEIVED BY PRODUCT ANALYSIS TO DATE.

    Description of Event or Problem · 0

    INFORMATION RECEIVED REPORTING THAT THE PATIENT'S GENERATOR HAS REACHED END OF SERVICE AND THE PATIENT HAD RECENTLY EXPERIENCED DIZZINESS AND FAINTING SPELLS. THE PATIENT HAVE ALLEGED THESE EVENTS TO BE RELATED TO THEIR DEVICE NO LONGER WORKING. A BATTERY LIFE CALCULATION WAS PERFORMED WHICH REVELED 0 YEARS REMAINING UNTIL REACHING NEOS = YES. NO KNOWN SURGICAL INTERVENTION HAS OCCURRED TO DATE. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Description of Event or Problem · 1

    PATIENT PRESENTED WITH INCREASE IN DEPRESSION AND NOTED THAT THEY CAN NO LONGER FEEL STIMULATION. SYSTEM DIAGNOSTICS SHOWED HLI. NO KNOWN 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
    37018 LEAD MODEL 302 LEAD MUZ LIVANOVA USA, INC. 302-20 1109

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR