BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL UNK

    MDR report key: 1040551 · Received May 9, 2008

    Report

    Report Number
    1644487-2008-01102
    Event Type
    Injury
    Date Received
    May 9, 2008
    Date of Event
    January 1, 2008
    Report Date
    April 9, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    REPORTER INDICATED THAT A VNS PATIENT WAS EXPERIENCING A SIGNIFICANT INCREASE IN SEIZURES. IT IS UNK IF THE INCREASE IN SEIZURES IS ABOVE, BELOW, OR AT PREVIOUS BASELINE. FOLLOW UP WITH THE SITE REVEALED THAT THE PT IS AT THE "HORRIBLE PUBERTY AGE" WHICH COULD BE CONTRIBUTING TO THE SEIZURE INCREASE. THE PHYSICIAN INDICATED THE VNS DEVICE IS "FINE," THOUGH THE SPECIFIC RESULTS OF DIAGNOSTICS WERE NOT PROVIDED. THE PHYSICIAN CHANGED MEDICATION FOR THE PT TO ADDRESS THE INCREASE IN SEIZURES. GOOD FAITH ATTEMPTS FOR ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Required Intervention