BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 1905380 · Received November 18, 2010

    Report

    Report Number
    1644487-2010-02596
    Event Type
    Injury
    Date Received
    November 18, 2010
    Date of Event
    February 1, 2010
    Report Date
    October 20, 2010
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 1

    REPORTER INDICATED A VNS PT HAD A LARGE SEIZURE IN (B)(6) 2010 THAT REQUIRED HOSPITALIZATION. THE PT HAS BEEN DOING WELL SINCE THAT TIME WITH HIS SEIZURES. ATTEMPTS FOR FURTHER 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 009728

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Male Required Intervention