BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 3170182 · Received June 14, 2013

    Report

    Report Number
    1644487-2013-01785
    Event Type
    Malfunction
    Date Received
    June 14, 2013
    Date of Event
    January 16, 2013
    Report Date
    May 22, 2013
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2013 CLINIC NOTES WERE RECEIVED DATED (B)(6) 2013 THAT INDICATED THE PATIENT HAS BEEN EXPERIENCING AN INCREASE IN SEIZURES; THE PATIENT HAD ABOUT 30 ABDOMINAL RUSHES (AVERAGING ABOUT 6 PER MONTH) WHICH IS AN INCREASE SINCE BEFORE (4 PER MONTH). THE PATIENT ALSO COMPLAINED OF ¿PULLING OF HER VNS¿ ABOUT ONCE A MONTH, LASTING FOR SEVERAL MINUTES, ESPECIALLY WHEN SHE IS LAYING DOWN AT NIGHT. THE PATIENT¿S SETTINGS WERE NOTED TO BE OUTPUT=3.25MA/FREQUENCY=20HZ/PULSE WIDTH=250USEC/ON TIME=60SEC/OFF TIME=1.1MIN/MAGNET OUTPUT=3.50MA/MAGNET ON TIME=60SEC/MAGNET PULSE WIDTH=250USEC. DIAGNOSTICS SHOWED RESULTS WITHIN NORMAL LIMITS OF OUTPUT=OK/LEAD IMPEDANCE=OK/IMPEDANCE VALUE=1673OHMS/NEOS=NO. THE CLINIC NOTES DATED (B)(6) 2013 INDICATE THAT THE PATIENT HAS HAD 20 AURAS BUT NO SEIZURES SINCE THE OFFICE VISIT ON (B)(6) 2013. GOOD FAITH ATTEMPTS FOR FURTHER INFORMATION FROM THE PHYSICIAN WERE UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271979 LEAD MODEL 302 LEAD LYJ CYBERONICS INC 302-30 201027

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR