BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENERATOR MODEL

    MDR report key: 1120667 · Received August 14, 2008

    Report

    Report Number
    1644487-2008-01902
    Event Type
    Injury
    Date Received
    August 14, 2008
    Date of Event
    January 1, 2008
    Report Date
    July 16, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED FROM A PHYSICIAN'S OFFICE THAT THEY WERE SCHEDULING A PT TO HAVE THEIR VNS GENERATOR MOVED RELATED TO PAIN THAT THEY WERE HAVING IN THEIR NIPPLE AREA. UNK IF THE SURGERY HAS OCCURRED. GOOD FAITH ATTEMPTS HAVE BEEN MADE FOR ADDITIONAL DETAILS FROM THE SITE AND THUS FAR NO FURTHER INFO HAS BEEN ATTAINED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other