BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 1910678 · Received November 22, 2010

    Report

    Report Number
    1644487-2010-02653
    Event Type
    Injury
    Date Received
    November 22, 2010
    Date of Event
    September 1, 2010
    Report Date
    October 27, 2010
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED BY THE PT THAT SHE WAS SEIZURE-FREE FOR ABOUT 25 MONTHS. IN (B)(6) , THE PT INDICATED THAT SHE HAD ABOUT 40 SEIZURES IN ABOUT 12-HOURS (A FEW GRAND MAL WITH MOSTLY COMPLEX PARTIAL). HER MEDICATIONS WERE SAID TO HAVE BEEN STARTED BACK UP AT THAT TIME. THE SEIZURES ARE SAID TO BE CONTROLLED SINCE THEN. THE PT COULD NOT INDICATE HER PRE-VNS BASELINE LEVELS, SO IT IS UNCLEAR IF THIS IS AN INCREASE FOR THE PT. GOOD FAITH ATTEMPTS TO OBTAIN ADDITIONAL INFO HAVE BEEN UNSUCCESSFUL TO DATE. THE PATIENT'S LAST KNOWN DIAGNOSTICS PERFORMED ON (B)(6) 2010 WERE INDICATED TO BE WITHIN NORMAL LIMITS. A SEARCH IN THE MANUFACTURER'S PROGRAMMING HISTORY DATABASE INDICATES THE LAST KNOWN DIAGNOSTICS PERFORMED ON (B)(6) 2008 WERE WITHIN NORMAL LIMITS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 102 LYJ CYBERONICS INC 102 200880

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Required Intervention