BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 1880353 · Received October 15, 2010

    Report

    Report Number
    1644487-2010-02309
    Event Type
    Malfunction
    Date Received
    October 15, 2010
    Date of Event
    June 21, 2010
    Report Date
    September 16, 2010
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THROUGH CLINIC NOTES THAT A VNS PT EXPERIENCED AN INCREASE IN SEIZURES DUE TO UNK REASON. PT MANAGEMENT FORM STATED SETTINGS ON (B)(6) 2010 WERE 2/25/250/30/1.8 AND THE LAST SYSTEM DIAGNOSTICS WERE (B)(6) 2008 - OK/DCDC=2, EOS = NO. GOOD FAITH ATTEMPTS TO OBTAIN ADDITIONAL INFO FROM THE TREATING NEUROLOGIST HAVE BEEN UNSUCCESSFUL TO DATE. MOREOVER, GOOD FAITH ATTEMPTS TO OBTAIN LEAD AND GENERATOR INFO HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 102 LYJ CYBERONICS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR