BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL UNK

    MDR report key: 1800080 · Received August 11, 2010

    Report

    Report Number
    1644487-2010-01844
    Event Type
    Malfunction
    Date Received
    August 11, 2010
    Date of Event
    July 13, 2010
    Report Date
    July 13, 2010
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY A PT LOOKING TO GET IMPLANTED WITH VNS THAT SHE WAS TOLD BY HER FORMER CO-WORKER THAT ANOTHER PT EXPERIENCED AN INCREASE IN SEIZURES AFTER BEING IMPLANTED WITH VNS. THE PERSON WHO REPORTED THIS EVENT HAS NO OTHER DETAILS AND DOES NOT KNOW WHO THE PT IS WHO EXPERIENCED THE INCREASE. GOOD FAITH ATTEMPTS TO OBTAIN ADDITIONAL INFO HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1