BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 2863499 · Received December 10, 2012

    Report

    Report Number
    1644487-2012-03256
    Event Type
    Injury
    Date Received
    December 10, 2012
    Date of Event
    February 10, 2012
    Report Date
    November 8, 2012
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THE PATIENT HAD AN INCREASE IN SEIZURES, UNKNOWN IF ABOVE OR BELOW BASELINE OR RELATED TO VNS. THE PHYSICIAN ADJUSTED THE PATIENT'S SETTING TO SEE IF THAT HELPED WITH THE INCREASE IN SEIZURES. THERE WERE NO MEDICATION CHANGES MADE IN THE YEAR PRIOR TO 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 102 GENERATOR LYJ CYBERONICS INC 102 010436

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Required Intervention