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.

St. Jude Medical offers trial systems for both spinal cord stimulation and dorsal root ganglion stimulation therapies.

Evaluation period

During the evaluation period and under a physician's care, you will have the opportunity to assess whether the therapy:

  • Provides adequate pain relief
  • Improves your ability to perform daily activities
  • Improves your sleeping habits

Temporary system components

Designed to closely mimic an implanted system, a temporary system usually consists of three components:

  • Leads: Thin wires that deliver stimulation to your nerves from the external generator.
  • External generator: A small device that sends pulses to the lead. The external generator can be taped or secured to your lower back and easily hides under your clothing so you can go about your day without anyone knowing you have it.
  • Patient controller: An external, handheld device that lets you adjust your therapy wirelessly.

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

Receiving 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 doctor’s office, 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 pulses).

During the procedure:

  1. Your doctor will place the temporary leads and test them to ensure they are placed correctly.
  2. After testing, your doctor will connect the leads to the small external generator that you will wear outside your body, typically on your lower back.
  3. In the recovery room, your St. Jude Medical representative will program your external generator, under your doctor’s guidance.

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
  • Refrain from lifting anything heavier than five pounds, which could cause the leads to move causing undesirable changes in stimulation

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. Patients do not experience discomfort at the end of the evaluation period, but may right after the procedure.

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

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.