BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 1252105 · Received December 4, 2008

    Report

    Report Number
    1644487-2008-02912
    Event Type
    Injury
    Date Received
    December 4, 2008
    Date of Event
    January 1, 2008
    Report Date
    November 5, 2008
    Manufacturer
    CYBERONICS, INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORTER INDICATED THAT THE PATIENT HAD BEEN HOSPITALIZED FOR BREAK-THOUGH SEIZURES. CURRENTLY THE PATIENT IS STILL HOSPITALIZED. THE RELATIONSHIP OF THE BREAK THROUGH SEIZURES TO VNS THERAPY IS UNK. ALL ATTEMPTS FOR FURTHER INFO HAVE BEEN UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 102 LYJ CYBERONICS, INC 102 012407

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Required Intervention