BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 1021321 · Received March 28, 2008

    Report

    Report Number
    1644487-2008-00820
    Event Type
    Injury
    Date Received
    March 28, 2008
    Date of Event
    February 1, 2008
    Report Date
    February 27, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORTER INDICATED THAT A VNS PT HAS EXPERIENCED A SEIZURE INCREASE, RELATIONSHIP TO PRE-VNS BASELINE UNK, AND IS CONCERNED THAT HIS GENERATOR IS APPROACHING END OF SERVICE. GOOD FAITH ATTEMPTS FOR 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 Other