BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 2180952 · Received July 22, 2011

    Report

    Report Number
    1644487-2011-01664
    Event Type
    Injury
    Date Received
    July 22, 2011
    Date of Event
    June 1, 2011
    Report Date
    June 23, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY A COMPANY REP THAT A VNS PT EXPERIENCED AN INCREASE IN SEIZURES DUE TO UNK REASON. A BLC WAS PERFORMED ON THE PT'S GENERATOR AND WITH THE AVAILABLE PROGRAMMING HISTORY IT WAS DETERMINED THAT THE GENERATOR WAS AT .15 YRS UNTIL ERI = YES. FURTHER INFO FROM A COMPANY REP INDICATED THAT THE PT WAS REFERRED TO PROPHYLACTICS REPLACEMENT DUE TO THE INCREASE IN SEIZURES. THE TREATING NEUROLOGIST ATTRIBUTED THE PT'S INCREASE IN SEIZURES TO LOSS OF THERAPY AND ELEVATION OF DC DC CODE. F/U BY A COMPANY REVEALED THAT THE DC DC CODE WAS 4, WHICH WAS A NORMAL VALUE. THE INFO WAS COMMUNICATED TO THE TREATING PHYSICIAN. INTERVENTIONS PLANNED WERE TO REPLACE THE PT'S GENERATOR.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Male Required Intervention