BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 1910049 · Received November 10, 2010

    Report

    Report Number
    1644487-2010-02531
    Event Type
    Malfunction
    Date Received
    November 10, 2010
    Date of Event
    October 1, 2010
    Report Date
    October 11, 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 INITIALLY REPORTED BY THE PT THAT HIS SEIZURE FREQUENCY AND SEVERITY HAS NOT IMPROVED WITH VNS. HE HAS THE SAME AMOUNT HE HAD PRIOR TO VNS AND SOME OF THE GTC ARE WORSE. PT ALSO INDICATED THAT HE HAS BEEN ON FEWER MEDICATIONS SINCE HE HAS BEEN ON VNS. PT STATED THAT HE IS NOT SURE IF HE HAS HAD ANY IMPROVEMENT WITH VNS. HE KNOWS HIS BATTERY IS AT END OF LIFE AND HE WILLING TO TAKE THE RISK AND WAIT TO SEE IF HIS CONDITION WORSENS. HE WILL FOLLOW UP WITH THE TREATING PHYSICIAN TO SEE WHAT NEEDS TO BE DONE. GOOD FAITH ATTEMPTS TO OBTAIN ADDITIONAL INFO HAS BEEN UNSUCCESSFUL TILL DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 102 LYJ CYBERONICS INC 102 11252

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR