BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 1180455 · Received September 26, 2008

    Report

    Report Number
    1644487-2008-02351
    Event Type
    Injury
    Date Received
    September 26, 2008
    Date of Event
    July 17, 2008
    Report Date
    September 10, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    MUZ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT EXPERIENCED SEVERE PAIN IN HER LOWER ABDOMEN. THE PHYSICIAN INDICATED THAT THE PAIN MAY BE RELATED TO STIMULATION. THE PT WAS HOSPITALIZED FOR THE PAIN, AND HER DEVICE SETTINGS WERE CHANGED WHICH RESOLVED THE PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 102 MUZ CYBERONICS, INC. 102 017084

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R