BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 2191136 · Received July 19, 2011

    Report

    Report Number
    1644487-2011-01612
    Event Type
    Malfunction
    Date Received
    July 19, 2011
    Date of Event
    June 8, 2011
    Report Date
    June 21, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY A NEUROLOGIST THAT A VNS PATIENT HAD HIGH IMPEDANCE WHEN SYSTEM AND NORMAL DIAGNOSTICS WERE RUN (SPECIFIC RESULTS NOT PROVIDED). PATIENT'S VNS DEVICE WAS NOT TURNED OFF DURING THE OFFICE VISIT THAT HIGH IMPEDANCE WAS NOTED. ADDITIONAL CLINIC NOTES WAS RECEIVED THAT PATIENT HAD APPROXIMATELY 1-2 SEIZURES PER MONTH WHICH IS HIS BASELINE LEVEL OF SEIZURE CONTROL. SUBSEQUENTLY, PATIENT'S GENERATOR AND LEAD WERE REPLACED ON (B)(6) 2011. GOOD FAITH ATTEMPTS TO OBTAIN MORE INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE. THE LEAD AND GENERATOR WERE RETURNED TO MANUFACTURER AND THEY ARE CURRENTLY UNDERGOING ANALYSES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAD MODEL 302 LYJ CYBERONICS, INC. 302-20 200614

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Male