Spinal Cord Stimulator Complications: What You Need to Know About Device Lawsuits

Chronic pain affects millions, and for some, a spinal cord stimulator (SCS) offers a beacon of hope. These devices, implanted to disrupt pain signals, can significantly improve quality of life. However, like any medical procedure, SCS implantation carries risks. While complications are relatively rare, they can be serious, leading to further medical intervention and, in some cases, legal action. In fact, since 2008, the FDA has received over 80,000 adverse reports related to spinal cord stimulators, including nearly 500 deaths, highlighting the potential for significant issues. If you or a loved one has experienced complications, understanding your rights and options is crucial.

What is a Spinal Cord Stimulator?

A spinal cord stimulator is a medical device used to manage chronic pain. It consists of thin wires (electrodes) placed near the spinal cord and a small, pacemaker-like battery pack (generator) usually implanted under the skin. The device sends electrical pulses to the spinal cord, interfering with pain signals before they reach the brain. This can reduce the perception of pain and improve a patient’s ability to function.

Common Complications of Spinal Cord Stimulators

While SCS devices can be effective, they are not without risks. Complications can arise from the surgery itself, the device, or how the body reacts to the implant. Here are some of the most common issues:

Infection: Infection is a significant risk with any implanted device. It can occur in the first 2-8 weeks after surgery and may require antibiotics or even surgical removal of the device. Infections are more common near the battery pack than in the leads.
Lead Migration: This is one of the most frequently reported complications. The electrodes can move from their original position, reducing the device’s effectiveness and requiring revision surgery to reposition them. Studies have shown lead migration rates ranging from 13.2% to 22.6%, though some studies report lower rates of migration requiring surgical revision.
Lead Breakage or Malfunction: The leads can break or malfunction due to the flexibility of the spine. This can result in loss of stimulation and require surgical repair. Lead fracture or disconnect occurs in 5.9%–9.1% of devices.
Device Damage: Falls or intense physical activity can damage the stimulator, requiring repair or replacement.
Battery Problems: The battery in the generator can deplete or malfunction, requiring replacement surgery. Some devices have rechargeable batteries, while others do not. Non-rechargeable batteries may need replacement after several years.
Pain at the Implant Site: Postoperative pain can occur at the generator or lead sites. This pain can sometimes be treated with conservative measures, but may require surgical revision if it doesn’t resolve.
Dural Puncture: During the procedure, the dura mater (the membrane surrounding the spinal cord) can be punctured, leading to cerebrospinal fluid leakage and severe headaches.
Spinal Cord Trauma: Though rare, nerve injury and paralysis can occur during the insertion of the stimulator.
Overstimulation or Understimulation: The device may not provide the correct level of stimulation, leading to discomfort, jolting sensations, or inadequate pain relief.
Allergic Reaction: Some patients may experience an allergic reaction to the materials used in the device.
Electromagnetic Interference: External sources of electromagnetic interference can interact with the system, causing unexpected changes in stimulation, injury, or death.
Gastrointestinal Issues: Though rare, some patients have reported gastrointestinal side effects such as constipation, abdominal pain, and distension.
Loss of Pain Relief: Over time, the device may become less effective, requiring adjustments or further intervention.

When to Seek Medical Attention

It’s important to contact your doctor immediately if you experience any of the following:

Inadequate pain relief despite adjusting the device settings.
Abnormal tingling or jolting sensations that are different from the usual stimulation.
Pain, swelling, redness, fluid discharge, or irritation around the implantation site.
Fever above 101°F.
Constant or worsening headaches, especially when leaning forward.
Sudden cessation of stimulation.
Any new or worsening symptoms after surgery.

Legal Options for Spinal Cord Stimulator Complications

If you have experienced complications from a spinal cord stimulator, you may have legal options. These cases often fall under product liability law, which holds manufacturers responsible for defective products that cause harm.

Types of Lawsuits

Product Liability Lawsuits: These lawsuits claim that the device was defective in its design, manufacturing, or marketing. This can include failure to warn patients and doctors of potential risks.
Medical Malpractice Lawsuits: These lawsuits claim that a healthcare professional was negligent in the implantation or management of the device, leading to injury. This could involve improper surgical technique, inadequate pre-operative planning, or failure to respond to complications.

Who Can Be Held Liable?

Device Manufacturers: Companies that design and manufacture the stimulators can be held liable for defective products. This includes companies like Abbott, Boston Scientific, Medtronic, St. Jude, and Nevro.
Healthcare Professionals: Doctors, surgeons, and hospitals can be held liable for negligence in the implantation or management of the device.
Distributors and Retailers: Parties involved in the distribution chain of the device can also be held liable.

What Damages Can You Recover?

If you win your case, you may be able to recover compensation for:

Medical Expenses: Past and future costs of medical treatment, including surgeries, medications, and rehabilitation.
Lost Wages: Compensation for lost income due to your injuries.
Pain and Suffering: Compensation for physical pain, emotional distress, and loss of enjoyment of life.
Other Related Costs: Additional expenses related to your injuries.

How to Proceed

Consult an Attorney: If you believe you have a case, consult with an experienced personal injury attorney specializing in medical device lawsuits. They can evaluate your case, explain your legal options, and guide you through the process.
Gather Evidence: Collect all relevant medical records, device information, and any reports or complaints filed against the manufacturer.
Understand the Legal Process: Filing a product liability lawsuit for a medical device defect is complex and often requires expert witnesses and a detailed knowledge of product liability law.

Taking Action

Experiencing complications from a spinal cord stimulator can be devastating. It’s important to understand that you are not alone and that legal options are available to help you seek justice and compensation for your injuries. If you or a loved one has suffered due to a defective spinal cord stimulator, it’s crucial to seek legal advice as soon as possible.

Have you experienced complications from a spinal cord stimulator? Contact us today for a free consultation to discuss your case and explore your legal options.