Spinal Cord Stimulator Injuries

Published medical literature estimates that 30 to 40 percent of spinal cord stimulator patients experience one or more complications. The FDA has received more than 220,000 adverse event reports related to SCS devices since 2004, including reports associated with over 900 patient deaths. For patients living with a spinal cord stimulator that is causing problems, recognizing the symptoms and understanding the potential causes is the first step toward getting help.

Hardware-Related Injuries

Hardware failures are the most commonly reported category of spinal cord stimulator complications. These involve malfunctions or failures of the device's physical components: the leads, the pulse generator, the battery, or the connections between them. Hardware problems are the primary focus of the pending federal lawsuits against Abbott and Boston Scientific.

Biological Complications

Biological complications arise from the body's response to the implanted device or from the surgical procedure itself, rather than from hardware failure. While less frequently reported than hardware issues, biological complications can be serious and in some cases life-threatening.

Infection

Infection at the surgical site or around the implanted device is one of the most common biological complications. The FDA's 2016–2020 adverse event data listed infection as the fifth most frequently reported patient problem, present in 7.5 percent of reports. Infections can develop at the incision sites, around the leads, or at the pulse generator pocket. Symptoms include redness, swelling, warmth, pain, and drainage at the implant site, along with fever. Severe infections may require surgical removal of the entire device and prolonged courses of intravenous antibiotics. In rare cases, untreated infections can progress to sepsis — a systemic inflammatory response that can be life-threatening.

Epidural Hematoma

An epidural hematoma is a collection of blood in the epidural space surrounding the spinal cord, which can develop during or after lead placement. While rare, an epidural hematoma is a medical emergency because the accumulating blood can compress the spinal cord and cause permanent neurological damage if not treated promptly. Patients taking anticoagulant medications may be at increased risk.

Cerebrospinal Fluid Leak

If a needle or electrode pierces the dura mater — the membrane surrounding the spinal cord — cerebrospinal fluid can leak from the puncture site. This complication, known as a dural puncture, typically causes severe headaches that worsen when sitting or standing and improve when lying down. Most dural puncture headaches resolve within one to two weeks, but some cases require an epidural blood patch procedure to seal the leak.

Pain at the Implant Site

Persistent pain, discomfort, or irritation at the location where the pulse generator is implanted is a commonly reported problem. In some cases, the generator pocket becomes a source of chronic pain in its own right, and patients have required surgical relocation of the device to a different part of the body. In the Martini v. Boston Scientific complaint, the plaintiff alleges that a battery relocation procedure was performed before the device was ultimately removed entirely.

Neurological Injuries

Neurological injuries represent the most serious category of spinal cord stimulator complications. Because the device's leads are placed in the epidural space directly adjacent to the spinal cord, any lead displacement, surgical error, or unintended electrical stimulation carries the potential for damage to the spinal cord or surrounding nerve roots.

Neurological injuries reported in connection with SCS devices include new or worsening numbness, tingling, or weakness in the extremities — symptoms that may indicate nerve root compression or irritation. In more severe cases, patients have reported partial or complete loss of motor function (paralysis), loss of bladder or bowel control, and sexual dysfunction. These injuries may be temporary if the underlying cause (such as lead displacement or hematoma) is identified and corrected promptly. In other cases, nerve damage from spinal cord stimulation may be permanent.

The FDA's 2016–2020 adverse event data listed "unexpected therapeutic effects" as the third most frequently reported patient problem at 10.9 percent, and pain as the second most common at 15.2 percent — both of which can indicate neurological involvement.

Warning Signs That Require Immediate Medical Attention

Certain symptoms associated with spinal cord stimulators indicate potentially serious complications that require urgent medical evaluation. If you experience any of the following, contact your physician or go to an emergency room immediately.

How to Document Your Symptoms

If you are experiencing complications with a spinal cord stimulator, documenting your symptoms thoroughly is important for both your medical treatment and any potential legal claim. The following steps can help preserve critical evidence.

• Keep a daily symptom log. Record the date, time, type, severity, and duration of each symptom — shocks, pain changes, numbness, device behavior changes. Note what you were doing when the symptom occurred and whether adjusting the device settings helped.
• Preserve all medical records. Request copies of all records from every provider involved in your SCS treatment: the implanting surgeon, pain management physician, primary care doctor, and emergency room visits. Include imaging studies (X-rays, MRIs, CTs) that show lead position.
• Record your device information. Write down the manufacturer name, device model name, model number, and serial number. This information is critical for a legal claim and should be available from your implanting physician or the device identification card you received.
• Document the impact on your life. Note specific activities you can no longer perform, days of work missed, sleep disruptions, and effects on your relationships and daily routine. These details are important for establishing damages in a legal claim.
• Report to the FDA. File a voluntary report through the FDA's MedWatch program at fda.gov/medwatch. This creates an official record of your adverse event and contributes to the agency's safety monitoring.
• Do not dispose of the device. If your spinal cord stimulator is surgically removed (explanted), ask your surgeon to preserve the device and all components. The explanted hardware is critical physical evidence in any legal claim.

When to Consider Legal Action

Not every spinal cord stimulator complication gives rise to a legal claim. The pending lawsuits against Abbott and Boston Scientific are based on specific allegations: that the devices were defectively designed, that they were approved through an improper regulatory process, and that the manufacturers failed to adequately warn physicians and patients about known risks.

You may have grounds for a legal claim if you were implanted with an Abbott or Boston Scientific spinal cord stimulator and experienced device failure, lead migration, lead fracture, electrical shocks, nerve damage, infection requiring device removal, or other complications that required additional surgery. You may also have a claim if your device simply failed to provide the pain relief that was demonstrated during the trial period — the FDA has received over 30,000 reports of unsatisfactory pain relief.

Most spinal cord stimulator lawsuits are handled on a contingency fee basis, which means there is no upfront cost to the patient. The attorney's fee is a percentage of any compensation recovered. If no compensation is obtained, there is no fee.

Statutes of limitations vary by state and typically range from one to three years from the date the injury was discovered or should have been discovered. Because these deadlines are strict and cannot be extended, consulting an attorney sooner rather than later is advisable.

Frequently Asked Questions