BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 101

    MDR report key: 1844636 · Received September 23, 2010

    Report

    Report Number
    1644487-2010-02160
    Event Type
    Injury
    Date Received
    September 23, 2010
    Date of Event
    June 23, 2009
    Report Date
    August 25, 2010
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THROUGH CLINIC NOTES DATED (B)(6) 2010 THAT A VNS PATIENT EXPERIENCED AN INCREASE IN SEIZURES ALONG WITH BEHAVIORAL CHANGES DUE TO AN UNK REASON. MOREOVER, A CLINIC NOTE FROM (B)(6) 2009 INDICATED THE PATIENT HAD AN INCREASE IN SEIZURES DUE TO UNK REASON. AT THE MOMENT, INTERVENTIONS PLANNED ARE TO REPLACE THE PT'S VNS. MOREOVER, GOOD FAITH ATTEMPTS TO OBTAIN ADD'L INFO FROM THE TREATING NEUROLOGIST HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 101 LYJ CYBERONICS, INC. 101 4399

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention