BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GEN MODEL 102

    MDR report key: 1102474 · Received August 8, 2008

    Report

    Report Number
    1644487-2008-01819
    Event Type
    Injury
    Date Received
    August 8, 2008
    Date of Event
    December 1, 2007
    Report Date
    July 10, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    MUZ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    INITIAL REPORTER INDICATED THAT SHE WAS IMPLANTED ABOUT A YEAR AGO. NOW SHE IS FEELING "FATIGUE AND THIRST" AND WONDERING IF THAT'S RELATED TO VNS. IT WAS ASKED WHEN DID HER SYMPTOMS START. SHE STATED THAT "HER DEVICE WAS TURNED OFF IN 2007, BECAUSE SHE COULDN'T TOLERATE THE SETTINGS. THROUGHOUT THAT TIME, SHE'S HAD MAJOR DEPRESSION. IT WASN'T UNTIL 2008, AFTER HER DEPRESSION LIFTED WAS SHE ABLE TO FEEL THE FATIGUE AND THIRST. SO THE DEVICE WAS NOT STIMULATING WHEN SHE FELT THESE SYMPTOMS, BUT SHE WASN'T SURE WHETHER THE PRESENCE OF THE DEVICE IN HER BODY AND ON HER NERVE COULD STILL CAUSE THESE SYMPTOMS." SHE STATED THAT "SHE WILL ALSO BE GETTING A SLEEP TEST TO SEE IF THERE'S ANYTHING WRONG." IT IS UNK IF THE DEPRESSION EVENT IS ABOVE THE PT'S PRE VNS RATE. GOOD FAITH ATTEMPTS ARE BEING MADE FOR ADDITIONAL DETAILS SURROUNDING THE EVENT AND THEIR RELATIONSHIP TO THE VNS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GEN MODEL 102 MUZ CYBERONICS, INC. 102 015644

    Patients

    Seq Age Sex Outcome Treatment
    1 Other