BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 102R

    MDR report key: 2191916 · Received July 22, 2011

    Report

    Report Number
    1644487-2011-01662
    Event Type
    Malfunction
    Date Received
    July 22, 2011
    Date of Event
    June 16, 2011
    Report Date
    June 24, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE
    Health Professional
    N

    Narratives

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THE PT HAD BEEN EXPERIENCING "A FLURRY OF SEIZURES AGAIN WITH A LOW GRADE TEMP OF 99.5". HE HAD THE SAME EVENT OCCUR A WEEK PRIOR. AT THAT POINT, HE WAS PLACED ON A HIGHER DOSE OF MEDICATION. ADD'L INFO WAS RECEIVED FROM THE PT INDICATING THAT HE HAD HIS VNS DEVICE CHECKED, AND IT WAS FUNCTIONING NORMALLY. NO SETTINGS OR MEDICATIONS WERE CHANGED. THE PT ALSO INDICATED THAT HIS FEVER WAS GONE AND THAT THE FLURRY OF SEIZURES WAS DECREASING. THE PT ALSO INDICATED THAT HE MADE NEED A REPLACEMENT SOON. NO DETAILS ON DIAGNOSTIC RESULTS, OR PROGRAMMED SETTINGS WERE PROVIDED BY THE PT. 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 009637

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Male