BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 101

    MDR report key: 1941217 · Received December 16, 2010

    Report

    Report Number
    1644487-2010-02824
    Event Type
    Malfunction
    Date Received
    December 16, 2010
    Date of Event
    May 1, 2010
    Report Date
    November 16, 2010
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT REPORTS HAVING AN INCREASE IN SEIZURE ACTIVITY SINCE (B)(6) 2010. AT THAT TIME, THE PT HAD A MEDICATION CHANGE, BUT IT IS UNK IF THIS IS BELIEVED TO HAVE CONTRIBUTED TO THE INCREASE IN 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 101 LYJ CYBERONICS, INC. 101 2702

    Patients

    Seq Age Sex Outcome Treatment
    1 Other