BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 1841833 · Received September 21, 2010

    Report

    Report Number
    1644487-2010-02138
    Event Type
    Malfunction
    Date Received
    September 21, 2010
    Date of Event
    August 26, 2010
    Report Date
    August 26, 2010
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT THAT WAS PREVIOUSLY SEIZURE FREE HAD BEGUN TO HAVE SEIZURES DAILY. THE PT STATED THAT HER MAGNET SWIPES WERE NO LONGER ABORTING SEIZURES BUT THAT IT HAD WORKED IN THE PAST. GOOD FAITH ATTEMPTS TO OBTAIN ADDITIONAL INFO HAVE BEEN UNSUCCESSFUL TO DATE AS THE PT WAS REFERRED TO A NEW PHYSICIAN AND HAS NOT FOLLOWED UP WITH THE PHYSICIAN YET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 102 LYJ CYBERONICS, INC. 102 200816

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR