BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 1993868 · Received February 11, 2011

    Report

    Report Number
    1644487-2011-00242
    Event Type
    Injury
    Date Received
    February 11, 2011
    Date of Event
    January 12, 2011
    Report Date
    January 12, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THROUGH CLINIC NOTES DATED (B)(6) 2009 THAT A VNS PT WAS HAVING MORE FREQUENT SEIZURES AND WENT TO THE HOSPITAL. THE PATIENT'S KEPPRA WAS LOWERED AS AN INTERVENTION AND AS A RESULT OF THE HOSPITAL VISIT A BLADDER INFECTION WAS DIAGNOSED. FURTHER REVIEW OF THE NOTES INDICATED THE PT HAD BLACKOUTS AND WERE CONSIDERED TO BE RELATED TO THE PATIENT'S SEIZURE NATURE. AT THE MOMENT, THE RELATIONSHIP OF THE FREQUENT SEIZURES TO THE INFECTION IS UNK AS GOOD FAITH ATTEMPTS TO OBTAIN ADDITIONAL INFO HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Female Required Intervention