Spinal Cord Stimulator

⚡ Spinal Cord Stimulator (SCS) and the Shadow of Medical Malpractice

The Spinal Cord Stimulator (SCS) is a medical device that has improved treatment of chronic, debilitating pain. The SCS sends mild electrical pulses to the spinal cord. It essentially “masks” or interrupts pain signals before they reach the brain. While a successful SCS implant can dramatically improve a patient’s quality of life, the procedure is not without risks. When medical negligence enters the picture, this powerful tool for pain relief can become the subject of complex and severe medical malpractice claims.

📜 History and Mechanism of SCS

A Brief History

The concept of using electrical impulses to treat pain is in the Gate Control Theory of pain. Wall and Melzack proposed it in 1965. This theory suggests that the transmission of pain signals can be modulated or “gated” by selectively activating large nerve fibers. The first clinical application of spinal cord stimulation came just two years later, in 1967. Since then, SCS technology has evolved significantly, moving from early systems to sophisticated, customizable devices. Routine clinical use began in the 1980s, and the U.S. Food and Drug Administration (FDA) first approved SCS for chronic pain relief in 1989. Newer advances include systems that provide pain relief without the tingling sensation (paresthesia). That sensation was characteristic of earlier devices, and advanced steering and targeting of the electrical field.

How the Spinal Cord Stimulator Works

An SCS system consists of two main components:

1. Electrodes (Leads): These thin, insulated wires are placed in the epidural space. (The area just outside the dura mater, the membrane covering the spinal cord).
2. Internal Pulse Generator (IPG): A battery-powered device, similar to a pacemaker, which is placed under the skin, usually in the buttock or abdomen.

The leads deliver low-voltage electrical current to specific nerve fibers in the spinal cord. This stimulation modifies the nerve activity, interrupting the abnormal pain signals that travel to the brain. The patient typically manages the system with an external remote control, changing the intensity and sometimes the program of stimulation for personalized pain management.

🎯 Who is the Spinal Cord Stimulator For?

SCS is generally reserved for patients with chronic pain (lasting six months or more) that has been refractory (unresponsive) to more conservative treatments, such as physical therapy, medication, and less-invasive procedures like injections. It is most commonly indicated for:

• Failed Back Surgery Syndrome (FBSS) / Persistent Spinal Pain Syndrome (PSPS): Persistent or recurring back and leg pain following spinal surgery.
• Complex Regional Pain Syndrome (CRPS): A chronic pain condition often affecting an arm or leg, usually after an injury.
• Neuropathic Pain: Pain arising from damaged nerves, which can be due to injury, disease (like painful diabetic neuropathy), or accident.
• Ischemic Pain: Pain caused by lack of blood flow, such as in refractory angina (chest pain) or chronic critical limb ischemia.

A successful SCS trial, where a temporary system provides at least 50% pain relief, is a common requirement for permanent implantation.

👩‍⚕️ Medical Providers Involved

The care team surrounding an SCS procedure is typically multidisciplinary.

Ordering and Recommending Providers

The decision to pursue SCS is often made by doctors specializing in chronic pain management after a comprehensive workup. These providers frequently order and manage the care plan:

• Pain Management Specialists (often Anesthesiologists or Physiatrists): These specialists lead the non-surgical management of chronic pain and are often the primary recommenders of SCS.
• Neurologists: May be involved in diagnosing the underlying neuropathic condition.
• Orthopedic Surgeons or Neurosurgeons: May consult on the patient’s spinal condition and history of prior surgeries.

Implanting Providers

The actual surgical implantation of the leads and IPG is performed by specialists with specific training in neuromodulation and spinal procedures:

• Neurosurgeons: Specialized in nervous system surgery.
• Interventional Pain Management Physicians: Often anesthesiologists or physiatrists who have completed specialized fellowship training in interventional techniques, including SCS placement.
• Orthopedic Spine Surgeons: Less common, but sometimes involved, especially for paddle lead placement needing a small laminectomy.

The choice of implanting provider often depends on the specific approach (percutaneous versus laminectomy) and the practice setting.

⚖️ Medical Malpractice Scenarios

Medical malpractice related to Spinal Cord Stimulators can occur in two major phases: negligence that causes a patient’s underlying condition to worsen, leading to the need for an SCS, or negligence during the SCS placement procedure itself.

Malpractice Leading to the Need for an SCS

In certain situations, a patient’s chronic pain may be the direct result of a medical professional’s negligent care. This requires an SCS as a last-resort treatment for a preventable injury.

In these cases, the malpractice centers on the initial negligent act or omission. That left the patient with a painful, debilitating condition for which SCS became medically necessary. The claim argues that had the first provider met the standard of care, the need for the SCS procedure—and its associated risks—would never have arisen.

Malpractice During Spinal Cord Stimulator Placement

Negligence during the actual SCS implantation procedure is a more direct cause for malpractice claims. It can lead to severe, life-altering injuries. The complexity of working near the delicate spinal cord means that even small errors can have catastrophic consequences.

Common Errors and Resulting Damage:

1. Improper Surgical Technique/Lead Misplacement:
   • The Error: The surgeon or interventionalist fails to place the electrode leads correctly within the epidural space. This is especially risky in patients with a history of prior spine surgery, as scar tissue (epidural adhesions) can make the epidural space difficult to navigate. Forcing a paddle lead through scar tissue can cause the lead to buckle and contact the spinal cord.
   • The Damage: Direct trauma or contusion to the spinal cord, leading to paralysis (paraplegia or quadriplegia), permanent weakness, or severe sensory loss. Incorrect placement can also lead to ineffective pain relief or stimulation of unintended nerves, causing new, painful electrical shocks.
2. Failure to Obtain or Misinterpreting Pre-operative Imaging:
   • The Error: Failing to secure necessary images (like an MRI or CT scan) to assess the spinal canal’s anatomy, or misinterpreting existing images (e.g., failing to account for spinal stenosis or prior surgical changes).
   • The Damage: Placing the leads in a compromised or narrow spinal canal significantly increases the risk of direct spinal cord or nerve root damage upon insertion.
3. Inadequate Intra-operative Monitoring:
   • The Error: For percutaneous procedures, the patient is often kept awake to provide real-time feedback if the lead makes contact with the spinal cord. Failure to have the patient provide feedback, or failure to use Intraoperative Neuro-monitoring (IONM) (like evoked potentials) to detect spinal cord compromise, can be a breach of the standard of care.
   • The Damage: An injury to the spinal cord may go unrecognized and uncorrected during the surgery, increasing the likelihood of permanent neurological deficits.

Additional Medical Malpractice

1. Negligent Post-operative Care:
   • The Error: Failing to properly monitor the patient in the recovery period and not recognizing or timely responding to a surgical complication. The most critical complication is a spinal epidural hematoma (bleeding in the epidural space).
   • The Damage: An epidural hematoma can compress the spinal cord. If not immediately diagnosed (often with an MRI) and surgically evacuated, the sustained pressure will cause irreversible spinal cord injury, leading to permanent paralysis or cauda equina syndrome. Failure of the recovery team to heed a patient’s complaints of sudden, severe, or worsening neurological symptoms (e.g., inability to move legs, sudden loss of bowel/bladder control) may constitute malpractice.

Summary

In summary, medical malpractice in SCS cases focuses on a failure to adhere to the medical “standard of care.” Whether the doctor followed that standard in the treatment that required the device. Or in the precise technique required for its safe implantation. The SCS has proximity to the central nervous system. Negligence in SCS placement often results in the most life-altering injuries, leading to substantial malpractice cases.

If you have any concerns or questions about a spinal cord stimulator, then visit our free consultation page or video. Then contact the Kopec Law Firm at 800-604-0704 to speak directly with Attorney Mark Kopec. He is a top-rated Baltimore medical malpractice lawyer. The Kopec Law Firm is in Baltimore and pursues cases throughout Maryland and Washington, D.C.