BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 101

    MDR report key: 2212584 · Received August 11, 2011

    Report

    Report Number
    1644487-2011-01818
    Event Type
    Injury
    Date Received
    August 11, 2011
    Date of Event
    July 14, 2011
    Report Date
    July 14, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD BEEN HOSPITALIZED, ORIGINALLY FOR DEHYDRATION. HOWEVER, IT WAS ALSO INDICATED THAT THE PATIENT WAS BEING MEDICATED FOR AN INCREASE IN SEIZURES AS WELL. THEY ARE UNSURE IF THE PATIENT'S GENERATOR IS AT EOS, HOWEVER, THE DEVICE HAS NOT BEEN CHECKED SINCE (B)(6) OF 2010. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 101 LYJ CYBERONICS, INC. 101 4223

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male Required Intervention