BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102R

    MDR report key: 2220196 · Received August 9, 2011

    Report

    Report Number
    1644487-2011-01813
    Event Type
    Injury
    Date Received
    August 9, 2011
    Date of Event
    July 12, 2011
    Report Date
    July 12, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT WAS EXPERIENCING AN INCREASE IN SEIZURES, AND WAS BEING REFERRED FOR A GENERATOR REPLACEMENT. THE REPLACEMENT HAS SINCE TAKEN PLACE, HOWEVER, THE DEVICE HAS NOT BEEN RETURNED. IT WAS REPORTED THAT THE GENERATOR WAS AT EOS, HOWEVER, IT IS UNK IF THE INCREASE IN SEIZURES IS ATTRIBUTED TO THE EOS STATE. ATTEMPTS FOR ADD'L INFO HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 102R LYJ CYBERONICS, INC. 102R 015227

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Female Required Intervention