BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GENERATOR 102

    MDR report key: 1812338 · Received August 17, 2010

    Report

    Report Number
    1644487-2010-01872
    Event Type
    Injury
    Date Received
    August 17, 2010
    Date of Event
    July 19, 2010
    Report Date
    July 19, 2010
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A VNS PATIENT EXPERIENCED AN INCREASE IN SEIZURES DUE TO UNKNOWN REASON. THE TREATING NEUROLOGIST REQUESTED A BATTERY LIFE CALCULATION WHICH INDICATED THE PATIENT'S GENERATOR WAS AT .07 YEARS UNTIL ERI=YES. ADDITIONAL INFORMATION WAS RECEIVED FROM THE TREATING NEUROLOGIST INDICATING THE PATIENT'S INCREASE IN SEIZURES WAS ABOVE PRE-VNS BASELINE AND WERE DUE TO UNKNOWN REASON. NO MEDICATION CHANGES WERE DONE WHICH COULD HAVE TRIGGERED THE INCREASE IN SEIZURES. FURTHER INFORMATION WAS RECEIVED FROM A COMPANY REPRESENTATIVE INDICATING THE PATIENT UNDERWENT PROPHYLACTIC GENERATOR REPLACEMENT SURGERY. GOOD FAITH ATTEMPTS TO OBTAIN THE EXPLAINED GENERATOR HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GENERATOR 102 LYJ CYBERONICS, INC. 102 013755

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Required Intervention