User Manual

10000890 REV 02
8
of what is going on. You may be given medication to help you relax and some numbing medicine for the insertion
site. The lead is placed in your body during a minor procedure usually without an incision. Once the lead has
been attached to the Trial Stimulator, the Trial Stimulator will either be placed in a pouch or wrapped in bandages
to your back. Most patients are able to leave the hospital the same day, depending on physical condition, the
procedure, and doctor’s preferences. Once the lead is in the body, you will typically use the Trial Stimulator over a
period of days as decided by your doctor. This provides an opportunity for you and your doctor to experience the
system on a temporary basis and evaluate how well the device might work for you.
If your SCS therapy works for you, you will move to the implant phase, during which an Implantable Pulse
Generator (IPG) will be implanted in your body. Your doctor will select the implant site based on your individual
body type and need. This procedure may be done under local or general anesthesia.
Following either of the implant procedures, you will be given instructions on how to care for the wound. You may
experience some pain and tenderness around the implant site. Tell the clinical team if you are uncomfortable or in
pain.
Following the IPG surgery, you may find you are very aware of the implanted device and may want to touch it. Try
to avoid twisting or fiddling with the IPG. If you manage to flip the implanted device over in your body, it will not
work properly. Do not pull on the lead, which can cause it to loosen or even come out. Touching the implant site
too much can cause your skin to get very thin in that area.
In the first weeks after surgery, avoid big and sudden movements, bending over, lifting heavy objects, and
stretching. Your IPG and lead(s) need a few weeks in the body to become secure. Your doctor or nurse will
advise you on what you should and should not do in these first weeks after implantation.
2.4 Trial Phase
If you are in the Trial Phase of SCS therapy, this is an exciting and important time. The Senza Bluetooth Trial
System may offer you a way to control your pain without taking more drugs. In fact, you may be able to
discontinue some of your drugs and still get pain control. To get the best results during this important time, please
follow your doctor’s advice closely.
When you are in the Trial Phase, you will receive a Trial Stimulator and a Remote Control so you have a chance
to see if SCS therapy works for you. If it works well for you, you will have an IPG implanted in the body to replace
the Trial Stimulator. This trial phase typically lasts several days.
For your trial, your doctor has set up a stimulation program for you. He or she has adjusted the device’s features
specifically for you. You will be given the external Trial Stimulator and a Remote Control. Using this system, you
can test the stimulation system to see how it works for you. At the end of the trial phase, you will discuss with your
doctor whether a device should be implanted in your body to take the place of the Trial Stimulator.