BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 4100841 · Received September 19, 2014

    Report

    Report Number
    1644487-2014-02381
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Date of Event
    January 17, 2006
    Report Date
    February 5, 2020
    Manufacturer
    LIVANOVA USA, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DESCRIBE EVENT OR PROBLEM, CORRECTED DATA: INITIAL REPORT INADVERTENTLY MENTIONED LACK OF EFFICACY THAT WAS NOTED FOR A DIFFERENT PATIENT. THE LACK OF EFFICACY FOR THE PATIENT IN THIS REPORT WAS NOT REPORTED UNTIL THE DATE THAT INFORMATION WAS RECEIVED FOR SUPPLEMENTAL REPORT #01.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED THAT THE PATIENT'S VNS WAS DISABLED DUE TO IT SHOCKING THE PATIENT AND NOT PROVIDING BENEFIT AT THE TIME THAT HIGH IMPEDANCE WAS IDENTIFIED. NO ADDITIONAL RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE. NO KNOWN SURGICAL INTERVENTION HAS OCCURRED TO DATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VNS PATIENT¿S DEVICE SHOWED HIGH IMPEDANCE. X-RAYS WERE TAKEN AND SHOWED THAT THE LEAD PIN MAY NOT BE FULLY INSERTED INTO THE GENERATOR HEADER. THE PATIENT¿S PARENTS ELECTED TO DISABLED THE PATIENT¿S DEVICE NOT AND PURSUE SURGERY. THE PATIENT¿S SEIZURE CONTROL DID NOT CHANGE DUE TO THE DISABLEMENT; HOWEVER, IT WAS NOTED THAT THE PATIENT MAY NOT HAVE HAD ANY EFFICACY WITH VNS PRIOR TO THE EVENT. NO KNOWN SURGICAL INTERVENTIONS HAVE OCCURRED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    582129 PULSE GEN MODEL 102 GENERATOR LYJ LIVANOVA USA, INC. 102 013476

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR