Temporary Trial Stimulation; Percutaneous Lead Placement Procedure - SALUDA MEDICAL Evoke SCS User Manual

• Gastrointestinal and/or genitourinary disruption or compromise.
• Inadequate pain relief following system implantation or over time.
• Erosion of the implanted components through the skin.
• Weakness, clumsiness, numbness, abnormal sensations or pain.
• Skin irritation.
Note: You may require surgery (including revision, explant and/or replacement) as a
result of any of the above.

5 Temporary trial stimulation

To test whether you will get a benefit from the Evoke spinal cord stimulation therapy, you may
have a temporary trial stimulation period.
• The trial usually lasts for up to a week, although some trials may last up to 30 days.
• During this trial stimulation period, you will have one or two 12C percutaneous leads
implanted in your spine by your clinician in a minor surgical procedure. Your surgeon
may also connect the leads to 12C lead extensions if required.
• After the surgery, the leads or lead extensions will be connected to an External Closed-
Loop Stimulator (eCLS) to deliver stimulation pulses through your leads to your spine.
o Your eCLS will be supplied fully charged. If the eCLS battery becomes depleted,
please return to your clinic for battery recharge or replacement.
• You will control the eCLS with the Evoke Pocket Console (EPC).

5.1 Percutaneous lead placement procedure

The leads will be implanted in your back near your spinal cord:
• In this procedure, you will lie face down, awake but sedated.
• Your skin will be cleaned and anesthetized with a local anesthetic.
• The surgeon will slide a small needle in your spine.
• A lead is inserted through the needle near the spinal cord.
• The surgeon may elect to turn the stimulation on to take recordings from your spinal
cord, or to test the stimulation, to make sure it is in the correct place in your back. You
may feel stimulation pulses (tingling) in various areas of your body at this time.
• The surgeon may move the lead to get a better position.
• This process is repeated if you require a second lead.
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Evoke® SCS System User Manual
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