BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 2180921 · Received July 22, 2011

    Report

    Report Number
    1644487-2011-01640
    Event Type
    Injury
    Date Received
    July 22, 2011
    Date of Event
    June 24, 2011
    Report Date
    June 24, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A PHYSICIAN'S OFFICE REPORTED THAT THE PT WAS CURRENTLY IN THE INTENSIVE CARE UNIT DUE TO AN INCREASE IN SEIZURES. IT WAS NOT KNOWN IF THE SEIZURES WERE ABOVE OR BELOW PRE-VNS LEVELS. THE PT'S LAST KNOWN SETTINGS WERE FROM (B)(6) 2010, AND DIAGNOSTIC TESTING ON THIS DATE SHOWED PROPER DEVICE FUNCTION. ATTEMPTS FOR FURTHER INFO HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 103 LYJ CYBERONICS, INC. 103 2495

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Hospitalization| R