6Adverse EffectsIn addition to those risks commonly associated with surgery, the following risks are associatedwith using this neurostimulation system: Unpleasant sensations or motor disturbances, including involuntary movement, caused bystimulation at high outputs (If either occurs, turn off your IPG immediately.) Undesirable changes in stimulation, which may be related to cellular changes in tissuearound the electrodes, changes in electrode position, loose electrical connections, or leadfailure Stimulation in unwanted places (such as radicular stimulation of the chest wall) Lead migration, causing changes in stimulation or reduced pain relief Epidural hemorrhage, hematoma, infection, spinal cord compression, or paralysis fromplacement of a lead in the epidural space Cerebrospinal fluid (CSF) leakage Paralysis, weakness, clumsiness, numbness, or pain below the level of the implant Persistent pain at the electrode or IPG site Seroma (mass or swelling) at the IPG site Allergic or rejection response to implant materials Implant migration or skin erosion around the implant Battery failureSystem OverviewThis neurostimulation system is designed to deliver electrical stimulation to nerve structures. Theneurostimulation system includes the following main components: Implantable pulse generator (IPG) Leads Clinician programmer Patient controller Patient magnetThe IPG delivers electrical pulses through the leads to electrodes near selected nerve fibers inorder to provide therapeutic stimulation. The patient magnet can turn the IPG on and off if thephysician enabled this functionality. Physicians use the clinician programmer to create andmodify programs for a patient. Patients use the patient controller to control their prescribedprograms.