BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 101

    MDR report key: 2250673 · Received September 16, 2011

    Report

    Report Number
    1644487-2011-02184
    Event Type
    Injury
    Date Received
    September 16, 2011
    Date of Event
    August 1, 2004
    Report Date
    August 25, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT INDICATED THAT THE PATIENT FELT THAT THE SEIZURES MAY BE RELATED TO STRESS AND ANXIETY. THE OFF TIME WAS ADJUSTED FROM 5 MINUTES OFF TO 3 MINUTES OFF.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THE PATIENT WAS HAVING AN INCREASE IN SEIZURE FREQUENCY AND MORE INTENSE SEIZURES WHICH WERE ABOVE PRE-VNS BASELINE. THE PATIENT'S SEIZURES IMPROVED AND WERE WELL CONTROLLED FOR ABOUT TWO YEARS POST IMPLANT BUT SINCE THAT TIME THEY HAVE BECOME WORSE. THE PATIENT'S DEVICE WAS REPORTED TO BE "OK" BY THE PHYSICIAN BUT HE IS CONCERNED ABOUT HER CONDITION SO PRESCRIBED HER MORE MEDICATIONS. GOOD FAITH ATTEMPTS FOR MORE INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED REGARDING THE PATIENT. THE CAUSE OF THE INCREASE IN SEIZURES IS UNCLEAR AT THIS TIME. BASED ON THE FAMILY REPORT THE PATIENT ONLY HAD GRAND MAL SEIZURES PRE-VNS. THE FAMILY FEELS THAT THE FREQUENCY AND INTENSITY HAS GOTTEN WORSE, BUT THE HISTORY OF THE PATIENT'S SEIZURES HAS NOT BEEN WELL DOCUMENTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 101 GENERATOR LYJ CYBERONICS, INC. 101 6288

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Required Intervention