Implant Procedure & Technique for Medtronic Spinal Cord Neurostimulation System from Medtronic

RestoreAdvanced for Spinal Cord Stimulation

Trial Procedure

Trial Procedure

A percutaneous lead is positioned in the epidural space on the dorsal aspect of the spinal cord at the appropriate nerve root level(s).
Leads are attached to an external pulse generator (screener) that supplies the current.
Electrical current from the lead generates paresthesia that can be adjusted in intensity and location to achieve the best pain coverage.
Patients can use the patient programmer to control the screener and adjust stimulation within clinician set parameters to meet pain management needs.

Related Manuals & Technical Resources

DualScreen Temporary Screening System Technical Manual

This is the instructions for use for the DualScreen™ Model 3628 Temporary Screening System, used during the SCS trial.

External Neurostimulator Technical Manual

The Medtronic Model 37022 External Neurostimulator is used to evaluate a Medtronic Neurostimulation System during lead placement or test stimulation. This manual includes the instructions for use.

Implant Procedure

A fully rechargeable or non-rechargeable neurostimulation system can be implanted as appropriate.

The procedure is performed in 2 steps:

The implantation of a lead (the lead placement may have already been done in the screening test)
The implantation of a neurostimulator

Before implantation, the clinician, with input from the patient, identifies the best placement site for the neurostimulator. The clinician should use a skin marker to mark the site. The abdominal or buttock area (away from the beltline) is typically recommended as the placement site for the neurostimulator.

The clinician should ensure that the appropriate settings have been programmed (in other words, 0 V amplitude, a pulse width of 210 µs, and a rate of 30 pps). Following implantation, the clinician adjusts the stimulation parameters as necessary to achieve effective pain relief, using the results of the screening test as a guide.

Overview of the Implant Procedure for a Spinal Cord Neurostimulation System

For more detailed information about the implant procedure, refer to the technical manual and the implantation guide available from Medtronic.

Step 1 Step 1

Prepare the patient using fluoroscopy to identify the appropriate vertebral intervals. Mark those intervals on the patient's skin.

Step 2 Step 2

Use a local anesthetic so the patient is alert and able to respond during the procedure. Then, insert a needle at the spinal location appropriate for the patient. Confirm the needle placement using fluoroscopy.

Step 3 Step 3

Introduce the lead through the needle and advance the lead tip to the spinal location corresponding with the patient's pain. Confirm lead placement in the epidural space using fluoroscopy. If more than one lead is to be used, repeat steps 2 and 3, placing a second needle for the second lead.

Step 4 Step 4

Connect the lead(s) to an external cable and the cable to an external power source called a screener. Test the effect of stimulation and adjust the parameters for optimal pain relief. The patient will provide verbal feedback regarding where he or she feels paresthesia (tingling) over the pain area.

If necessary, adjust the lead position(s) for optimal pain relief. When good paresthesia is achieved, anchor the lead(s) in place. The patient uses the screener for several hours up to a few days to test the effectiveness of stimulation on his or her pain.

Step 5 Step 5

If the patient achieves pain control of at least 50% during the screening test period, the physician and patient may agree to proceed with implantation of the system.

	If the physician uses a surgically-placed, paddle-type lead(s), proceed with step 6.
	If the physician uses the same lead(s) as used during the screening test, proceed to step 8 for the internalization of the neurostimulator.
	If the physician uses a percutaneously placed lead(s), but not the one(s) used during the screening test, repeat steps 1-4 to place the lead(s) for the implanted system, then continue with step 8 for the internalization of the neurostimulator. Repeat Steps 1-4; then go to Step 8.

Step 6 Step 6

Perform the appropriate surgical procedure to expose the dura mater. Introduce a lead blank (same size and shape as the lead, but without electrodes) at a shallow angle to prepare the pathway. Remove the lead blank. Pass the surgical lead until the entire lead paddle is in the epidural space.

Step 7 Step 7

When the lead is in place, connect the lead to an external cable, and the cable to the screener. Adjust the lead position for optimal pain coverage (as was done during the screening test, step 4). When testing is complete, disconnect the external cable.

Step 8 Step 8

Anchor the lead and proceed with implantation of the neurostimulator. Create a subcutaneous pocket (generally in the patient's abdominal area) for the neurostimulator.

Step 9 Step 9

Create a tunnel for the extension. Pass the extension through the tunnel and connect to the lead. Next, connect the other end of the extension to the neurostimulator.