Generator, Neurostimulator (Implantable), High Frequency, with Rechargeable Battery and Charging System (C1822)

Name of the Procedure:

• Common Names: Neurostimulator Implant, Spinal Cord Stimulator, High-Frequency Neurostimulator
• Technical Term: Generator, Neurostimulator (Implantable), High Frequency, with Rechargeable Battery and Charging System (C1822)

Summary

This procedure involves implanting a high-frequency neurostimulator—a specialized device used to deliver electrical impulses to nerves. It's intended to reduce chronic pain that has not responded to other treatments. The system includes a rechargeable battery and a charging unit to maintain the device's functionality.

Purpose

The neurostimulator is designed to manage chronic pain conditions such as failed back surgery syndrome, complex regional pain syndrome (CRPS), and other intractable neuropathic pain syndromes. The goal is to improve the patient's quality of life by significantly reducing pain, thereby reducing the need for pain medications.

Indications

• Chronic pain lasting more than six months
• Pain that is not responsive to conventional treatments (medications, physical therapy, surgery)
• A positive response to a neurostimulation trial

Preparation

• Patients may need to fast for several hours before the procedure.
• Medication adjustments may be required, especially if on blood thinners.
• Pre-procedure diagnostic tests may include imaging studies (MRI, CT scans) and a psychological evaluation to ensure the patient is a good candidate.

Procedure Description

1. Anesthesia: Typically performed under local anesthesia with sedation or general anesthesia.
2. Incision: A small incision is made near the spine for electrode placement and another for the implantable pulse generator (IPG).
3. Electrode Placement: Electrodes are guided to the epidural space near the spinal cord.
4. IPG Implantation: The IPG is implanted under the skin, usually in the lower back or abdomen.
5. Connection and Testing: Electrodes are connected to the IPG, and the system is tested to ensure proper functioning.
6. Closure: Incisions are closed with sutures or surgical glue.

Duration

The procedure typically takes about 1-2 hours.

Setting

The neurostimulator implant procedure is usually performed in a hospital operating room or an outpatient surgical center.

Personnel

• Surgeon (usually a neurosurgeon or an interventional pain specialist)
• Anesthesiologist
• Surgical Nurses
• Medical Device Technician (for device programming and testing)

Risks and Complications

• Common risks: Infection at the incision site, bleeding, device malfunction
• Rare risks: Nerve damage, spinal fluid leakage, allergic reaction to the device materials
• Management: Monitoring for signs of complications post-procedure and providing appropriate interventions, such as antibiotics for infections.

Benefits

• Significant reduction in chronic pain
• Decreased dependency on pain medications
• Improved quality of life and ability to perform daily activities

Recovery

• Post-procedure: Monitoring in a recovery area for a few hours.
• Instructions: Keep the incision sites clean and dry, avoid strenuous activities for several weeks.
• Follow-up: Regular appointments to check device functioning and adjust settings as needed.
• Recovery Time: Most patients resume normal activities within a few weeks.

Alternatives

• Medications: Pain relievers, anti-inflammatory drugs, opioids
• Non-invasive therapies: Physical therapy, acupuncture
• Other interventions: Pain pump, nerve blocks, or alternative neurostimulation techniques
• Comparison: Medications may only provide temporary relief and have side effects, while neurostimulation offers a more long-term and targeted pain management solution.

Patient Experience

During the procedure, patients will be under anesthesia and should not feel any pain. Post-procedure, they may experience soreness at the incision sites and mild discomfort. Pain management options like prescribed pain relievers and comfort measures such as ice packs can help mitigate post-surgical pain. Follow-up care ensures the device continues to function optimally and the patient achieves the best possible pain relief.