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Trying a Temporary Neurostimulation System

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Safety and use information

Safety and Use

Find important safety information for our implantable devices and systems.

Trying a Temporary Neurostimulation System

A temporary neurostimulation system allows you and your doctor to determine the effectiveness of neurostimulation for your pain before undergoing a permanent implant. You will be fitted with a temporary or trial device that works like an implanted system but can be easily removed. It is important to talk with your doctor about what is involved in receiving a temporary system.

Evaluation period

During the evaluation period, you will be able to assess how well the system manages your pain throughout the day and, if instructed by your doctor, during different activities. After the evaluation, you and your doctor will discuss your experience.

Temporary system components

When you receive a temporary system, only the leads are placed in your body. The leads are connected to an external pulse generator (outside of your body) that you can use to receive stimulation and change the intensity of the stimulation. The external pulse generator does not usually show under your clothes.

 

Drawing of male holding programmer shows placement of EPG on the body and location of stimulationDrawing of male holding the St. Jude Medical™ Invisible Trial System Patient Programmer

The procedure to receive a temporary system

You will have a short, minimally invasive procedure, during which you are awake and answering questions. The procedure is often performed at a hospital or day surgery center. You may receive medication to help with any discomfort and anxiety you may feel when your doctor or surgeon inserts the leads (thin wires that deliver electrical pulses).

During the procedure, your surgeon will:

  • Implant a few small, thin leads along your spinal column. The leads will typically be placed using a special needle while you are lightly sedated.
  • Test to ensure that the leads are placed correctly.
  • Connect the lead to the small external generator that will be worn outside the body, typically on your lower back.

Most patients report very little discomfort, if any, during the procedure. Many report some soreness at the insertion site afterward. Afterward, you will be shown how to use your patient controller (an external, handheld device that lets you adjust your therapy wirelessly). The patient controller for the St. Jude Medical™ Invisible Trial System is an Apple™ iPod touch™ mobile digital device.

Procedure risks

Receiving a temporary system is a surgical procedure that will expose you to risks, such as:

  • Infection
  • Swelling
  • Bruising
  • Loss of strength or use in an affected limb or muscle group (e.g., paralysis)

Be sure to talk to your doctor about all risks associated with the placement of a temporary system. 

During the evaluation period

You may continue to perform most of your usual activities during your evaluation period with some exceptions. Your doctor may advise that you:

  • Avoid bending, stretching or twisting
  • Try light activities, such as walking, to see if neurostimulation relieves your pain during those activities
  • Avoid strenuous activities
  • Do not lift anything heavier than five pounds, which could cause the leads to move causing undesirable changes in stimulation

Be sure to ask your doctor about activities, including work and hobbies, that you can and cannot do during this time.

After the evaluation period

At the end of your evaluation period, your doctor will remove the temporary system. Most of the time, you can resume your usual activities after the evaluation procedure. Some patients experience minor discomfort, but recovery time is minimal for most patients.

The next step is for you and your doctor to discuss your experience and whether or not you should get an implanted system.

Be sure to discuss the following with your doctor:

  • Any possible complications associated with the implant procedure and other important safety information, including:
    • Restrictions you will be asked to follow during your recovery and for the long term
    • Details about who will perform your procedure. You may schedule the procedure with your doctor’s office, or your doctor may refer you to a surgeon.

Apple and iPod touch are trademarks of Apple, Inc.