BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 2853026 · Received November 30, 2012

    Report

    Report Number
    1644487-2012-03162
    Event Type
    Injury
    Date Received
    November 30, 2012
    Date of Event
    April 3, 2012
    Report Date
    October 31, 2012
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THE PATIENT HAS A SEIZURE WHICH LEAD TO THE PATIENT GOING TO THE EMERGENCY ROOM. THE PATIENT HAD THEIR DILANTIN INCREASED AS A RESULT. THERE WAS NO COMMENT ON THE RELATIONSHIP OF THE SEIZURE TO VNS. DIAGNOSTICS RUN AT A LATER DATE SHOWED THE GENERATOR WERE NOT PRODUCT ISSUES. GOOD FAITH ATTEMPTS FOR ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT IT IS UNCLEAR IF SEIZURE WERE RELATED TO VNS AS IT MAY BE PART OF THE PATIENT'S NORMAL SEIZURE PATTERN. THE PATIENT HAS MANY SEIZURES AND FLUCTUATION IS PART OF HIS NORMAL SEIZURE PATTERN. NOT FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 102 GENERATOR LYJ CYBERONICS, INC. 102 011406

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Required Intervention