BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 3864034 · Received June 10, 2014

    Report

    Report Number
    1644487-2014-01456
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    April 2, 2014
    Report Date
    May 13, 2014
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    AN ADVERSE EVENT FORM FOR A STUDY PATIENT WAS RECEIVED INDICATING THAT THE PATIENT SUFFERED AN INCREASE IN SEIZURES. IT WAS NOTED THAT THE SEVERITY OF THE SEIZURES WAS MODERATE AND RESULTED IN A PROLONGED HOSPITALIZATION FOR THE PATIENT. IT WAS NOTED THAT TREATMENT WAS NOT CHANGED AND THE PATIENT RECOVERED. THE RELATIONSHIP TO DEVICE STIMULATION, IMPLANT, AND THE STUDY WAS NOTED TO BE UNLIKELY. THE PATIENT DID NOT DISCONTINUE THE STUDY AS A RESULT. FURTHER FOLLOW-UP REVEALED THAT THE INCREASE IN SEIZURES WAS NOT DUE TO A LOSS OF VNS THERAPY. DEVICE DIAGNOSTICS WERE WITHIN NORMAL LIMITS (2596 OHMS).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341078 PULSE GEN MODEL 103 GENERATOR LYJ CYBERONICS INC 103 202303

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Hospitalization| R