BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 104

    MDR report key: 2181257 · Received July 8, 2011

    Report

    Report Number
    1644487-2011-01534
    Event Type
    Malfunction
    Date Received
    July 8, 2011
    Date of Event
    June 8, 2011
    Report Date
    June 10, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO OUR COUNTRY REP IN THE UNITED KINGDOM THAT THERE WAS A PT WHO WAS HAVING AN INCREASE IN SEIZURES. IT IS NOT KNOWN AT THIS TIME IF THEIR SEIZURES WERE ABOVE OR BELOW THEIR PREVENS RATE. DIAGNOSTICS WERE REPORTED TO BE WITHIN NORMAL LIMITS. EVENT NOT BELIEVED TO BE RELATED TO ANY SURGICAL ISSUE. THE PT WILL BE SEEN BACK IN CLINIC FOR EVAL. GOOD FAITH ATTEMPTS ARE UNDERWAY FOR FURTHER DETAILS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 104 LYJ CYBERONICS, INC. 104 201423

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR