BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENERATOR

    MDR report key: 1251993 · Received December 4, 2008

    Report

    Report Number
    1644487-2008-02926
    Event Type
    Injury
    Date Received
    December 4, 2008
    Date of Event
    August 1, 2008
    Report Date
    November 6, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    INITIAL REPORTER INDICATED THAT THEIR PATIENT WAS EXPERIENCING VOMITING AND ALSO RECENTLY HAD AN INCREASE IN SEIZURES. IT IS UNK IF THE SEIZURES ARE ABOVE OR BELOW THEIR PRE VNS BASELINE SEIZURE RATE. THE VOMIT EVENT IS REFERENCED IN MDR REFERENCE NUMBER: 1644487-2008. IT WAS REPORTED THAT THE PATIENT'S GENERATOR WAS PROGRAMMED TO 0MA AND THE PATIENT CONTINUED TO VOMIT. THE PATIENT HAS BEEN VOMITING FOR 1 YEAR. HIS SEIZURES BEGAN TO INCREASE, THREE MONTHS LATER, THE PHYSICIAN SET THE GENERATOR TO .25/30/500/30/5 AND HE CONTINUED TO HAVE SEIZURES. THEN COUPLE WEEKS LATER SET GENERATOR TO .5/30/500/30/5. PATIENT IS STILL EXPERIENCING SEIZURES AND VOMITING. THE PHYSICIAN REPORTED THAT SHE WAS GOING TO TRY DIFFERENT MEDICATIONS. NO SYSTEM DIAGNOSTIC TEST HAS BEEN PERFORMED AS THE PATIENT SETTINGS ARE NOT HIGH ENOUGH AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GENERATOR LYJ CYBERONICS, INC. 101 38009C

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Required Intervention