Spinal Cord Stimulator Lawsuit [May 2026 Update]

Spinal Cord Stimulator Lawsuit Overview

Spinal cord stimulator systems are medical devices implanted to manage chronic pain by delivering electrical pulses intended to interrupt nerve signals before they reach the brain.

Although these medical devices implanted in the spine are promoted as a long-term pain solution, a growing number of patients have reported serious complications, including painful electrical shocks, worsening pain, neurological injury, device migration, burns, and the need for revision surgery.

Federal safety data reflects the scope of these concerns.

The FDA has received tens of thousands of adverse event reports involving spinal cord stimulator systems, including reports associated with serious injury and death.

Spinal cord stimulator lawsuits allege that major medical device manufacturers introduced and modified these systems without adequate testing, failed to warn patients and physicians of known risks, and continued marketing devices that allegedly demonstrated abnormal or unsafe performance after implantation.

Recent filings also show that this litigation is expanding.

Plaintiffs have sought to consolidate federal cases involving spinal cord stimulators into a potential spinal cord stimulator MDL, with lawsuits filed across multiple jurisdictions raising similar allegations involving device failure, inadequate warnings, and post-approval design changes.

A motion was filed with the U.S. Judicial Panel on Multidistrict Litigation to consolidate spinal cord stimulator lawsuits involving Abbott and Boston Scientific, citing shared factual and legal questions regarding device design and federal regulatory compliance.

These cases focus on whether manufacturers can be held responsible when a device intended to treat chronic pain instead leads to additional procedures, long-term complications, or permanent injury.

Claims being investigated involve patients who experienced loss of pain relief, repeated reprogramming, revision or explant surgery, and other complications following implantation of spinal cord stimulator systems.

Individuals who suffered serious complications, or families who lost a loved one following implantation, may have grounds to pursue a spinal cord stimulator lawsuit based on the specific device used and the injuries sustained.

TorHoerman Law is actively investigating these claims and evaluating cases involving spinal cord stimulators that allegedly caused harm instead of the relief patients were led to expect.

What Do Spinal Cord Stimulator Lawsuits Allege?

Spinal cord stimulator lawsuits allege that certain devices were defectively designed or manufactured, leading to serious injuries after implantation.

Plaintiffs claim these systems can malfunction in ways that cause overheating, internal burns, nerve damage, and other complications that were not adequately disclosed.

Many lawsuits also point to hardware-related failures, including premature lead migration, lead fractures, and battery failure, which may require additional surgery to correct.

Failure to warn patients about the likelihood of revision procedures is a central allegation, particularly given research suggesting that a significant percentage of patients require surgical reintervention after implantation.

Common allegations in spinal cord stimulator lawsuits include:

• Defective design and manufacturing leading to device failure and injury
• Overheating of devices resulting in internal burns
• Premature lead migration, lead fractures, and battery malfunction
• Failure to warn about the risk of revision surgery or explant procedures
• Neurological complications, including nerve damage and deficits

What is the Average Spinal Stimulator Lawsuit Settlement Amount?

There is no fixed average spinal stimulator lawsuit settlement amount, but current estimates place many claims somewhere between $90,000 and $2.5 million depending on the severity of the injury and the treatment required.

Cases involving one revision surgery without explantation are often valued at the lower end of that range, with estimates commonly falling between $90,000 and $250,000.

Claims involving multiple surgeries, explant procedures, worsening mobility, or documented neurological injury may carry substantially higher value.

Some estimate an average spinal cord stimulator settlement at about $1.9 million, but that figure appears to come from a limited pool of reported cases and should not be treated as a guaranteed benchmark.

Other reporting has placed the average closer to $303,173, which shows how widely these cases can vary based on the facts.

One reported 2024 case resulted in a $1.25 million settlement after a patient alleged that a spinal cord stimulator worsened his pain and mobility.

The value of any spinal stimulator lawsuit usually depends on the number of revision surgeries, whether the device was removed, the extent of documented injury, and how severely the complications affected the person’s daily life.

Spinal Cord Stimulator Injury Risks

Although these devices offer pain relief for some, their use also involves significant risks that can severely impact a patient’s health and quality of life.

Common issues include infection at the surgical site, device malfunctions, and even neurological complications if the device moves or fails.

Spinal cord injury is also a major risk.

These risks have led many patients to experience further injury instead of relief, with complications that sometimes require additional surgeries.

For some, the implantation process itself can result in adverse effects like dural punctures or allergic reactions to device materials.

Patients considering spinal cord stimulation should weigh these potential complications with their medical providers to make fully informed choices.

Severe complications and injuries linked to spinal cord stimulators include:

• Infection: The implantation procedure carries a risk of infection at the surgical site, which can lead to serious complications if not promptly addressed.
• Device Migration and Malfunction: Issues such as lead migration (movement of the electrodes), hardware failure, or battery problems can occur, potentially diminishing the device’s effectiveness or causing discomfort.
• Neurological Complications: Improper placement or movement of the device can result in nerve damage, leading to symptoms like weakness, numbness, or even paralysis.
• Dural Puncture: Accidental puncture of the epidural space during implantation can cause cerebrospinal fluid leaks, leading to headaches and other complications such as epidural hematoma.
• Allergic Reactions: Some patients may experience allergic reactions to the materials used in the device, resulting in skin irritation or other systemic responses.
• Chronic Pain Worsening: In some cases, the stimulator may not only fail to alleviate pain but can also exacerbate the patient’s original pain condition, leading to increased discomfort and additional pain management needs.
• Scar Tissue Formation: As with many implanted devices, scar tissue can build up around the stimulator, which may impair its function and lead to further complications.
• Electrical Shocks or Burns: Patients have reported sensations of electric shocks or burns caused by device malfunctions, which can be distressing and even injurious if severe.
• Battery Replacement and Surgical Risks: Device batteries may need to be replaced over time, necessitating additional surgeries and bringing cumulative risks related to multiple procedures.
• Psychological Impacts: Patients may experience psychological impacts, including anxiety and depression, particularly if the device causes additional complications or fails to relieve pain as expected.

It’s essential for patients to discuss these potential risks with their healthcare providers to make informed decisions about undergoing spinal cord stimulator implantation.

What is Spinal Cord Stimulation?

Spinal cord stimulation (SCS) is a medical treatment used in chronic pain management when other approaches have failed to alleviate chronic pain.

During a spinal cord stimulator operation, leads are placed in the epidural space near the spinal canal and connected to an implantable pulse generator that delivers electrical impulses to modify how pain signals are processed.

This therapy is typically considered for patients living with chronic intractable pain, including conditions such as failed back surgery syndrome or neuropathic pain.

Modern spinal cord stimulators are usually introduced after medications, physical therapy, and other forms of medical treatment have not provided sufficient relief.

Spinal cord stimulation differs from non-implantable options like transcutaneous electrical nerve stimulation and percutaneous electrical nerve stimulation, which use external or temporary electrodes.

Related approaches such as peripheral nerve stimulation and peripheral nerve field stimulation target different areas of the nervous system, while spinal cord stimulation focuses on the spinal canal.

How are Spinal Cord Stimulators Implanted?

The implantation of a spinal cord stimulator (SCS) involves a two-step process: a trial phase and, if successful, a permanent implantation.

This staged approach helps determine if spinal cord stimulation provides adequate pain relief before committing to a permanent device.

Step 1: Spinal Cord Stimulator Trial

The spinal cord stimulator trial period begins with a minimally invasive procedure, where thin electrical leads (electrodes) are inserted into the epidural space around the spinal cord.

These leads are connected to an external pulse generator worn outside the body.

Patients usually undergo local anesthesia or mild sedation for this procedure, which allows the orthopedic surgeon to position the leads precisely and test their effectiveness in real-time.

The goal is to see if the device reduces pain enough to justify a permanent implant.

The trial period typically lasts around 5-7 days, during which the patient assesses the level of pain relief and reports any issues.

If the trial is successful, the patient may proceed to the permanent implantation phase.

Step 2: Permanent Implantation

If the trial procedure successfully reduces pain, the next step involves placing a permanent spinal cord stimulator.

During this procedure, the surgeon performs spinal cord stimulator placement under local or general anesthesia, positioning the device’s leads near the spinal nerve root in the same epidural space used during the trial phase.

The implant also includes a small pulse generator, inserted beneath the skin (most often in the abdomen or buttocks) which connects to the leads to deliver steady electrical signals.

Once positioned, the system is programmed to provide continuous pain relief tailored to the patient’s needs.

Many spinal cord stimulators are designed with advanced technology that allows customizable programming and adjustable stimulation patterns.

Some models use rechargeable spinal cord stimulators, which patients recharge through an external wireless system, while others rely on non-rechargeable batteries that typically require surgical replacement after several years.

This permanent implantation allows patients to receive ongoing therapy without repeated external procedures, but it also introduces the potential for long-term complications if the device malfunctions or shifts from its intended placement.

Post-Procedure and Device Calibration

After implantation, the device is calibrated and programmed to meet the patient’s specific pain relief needs.

Patients are trained to use a handheld remote control, allowing them to adjust the stimulation level or turn the device on and off.

Initial follow-up appointments are crucial for fine-tuning the stimulator settings and ensuring the device functions optimally.

Over time, as the patient’s condition or pain levels change, additional adjustments may be made to maintain effective pain relief.

Recovery and Long-Term Maintenance

Recovery from the implantation procedure can take a few weeks, during which patients are advised to limit certain physical activities to allow the device and leads to settle.

Long-term, patients may require periodic adjustments, and in some cases, the device may need to be repositioned or replaced due to complications like lead migration, device malfunction, or battery depletion.

Proper maintenance and regular medical follow-up ensure that the spinal cord stimulator continues to provide effective pain relief over time.

Types of Spinal Cord Stimulator Devices and Manufacturers

Spinal cord stimulation as a treatment for chronic pain originated in the late 1960s when the first devices were introduced to target pain pathways directly within the nervous system.

Over the following decades, advancements in technology allowed these devices to evolve, providing greater control over pain management with more compact, reliable models.

By the 1990s, spinal cord stimulators had gained FDA approval for broader use, though their effectiveness varied significantly among patients.

Improvements in the 2000s brought rechargeable batteries, high-frequency stimulation options, and patient-controlled settings, further enhancing their appeal as an alternative to long-term pain medication.

Today, spinal cord stimulators are manufactured by multiple medical companies, each producing various models to cater to specific types of chronic pain and patient needs.

Types of Spinal Cord Stimulator Devices and Manufacturers include:

• Traditional Low-Frequency Stimulators: Manufactured by Medtronic, Abbott, Boston Scientific, and others.
• High-Frequency Stimulators: Manufactured by Nevro (HF10), Boston Scientific, and others.
• Burst Stimulation Devices: Manufactured by Abbott (BurstDR) and others.
• Rechargeable vs. Non-Rechargeable Models: Manufactured by Medtronic, Boston Scientific, Nevron, Abbott, and others.
• Fully-Implantable vs. External Power Source Options: Manufactured by Boston Scientific, Abbott, and others.

These types of spinal cord stimulators provide varied methods and technologies to address specific pain needs.

Medical malpractice claims, medical negligence claims, and product liability lawsuits have named several different types of spinal cord stimulators.

Limitations and Risks of Spinal Cord Stimulators

Spinal cord stimulators offer relief for many patients, but they come with notable limitations and risks.

For one, these devices are not universally effective; up to 30% of patients report little to no improvement in their pain levels and opt for removal, even after proper implantation and use.

Complications such as device migration, where the electrode moves from its intended position, can impact the device’s effectiveness and may require corrective spinal surgery.

There’s also a risk of infection at the implant site, which can be severe enough to warrant removal of the device.

In rare cases, patients may experience neurological side effects like numbness or even paralysis due to issues like epidural hematoma or nerve damage during insertion.

Battery life is another limitation, as the devices require battery replacement, which involves additional surgeries over time.

Spinal cord stimulators come at a significant financial cost, and insurance coverage may vary, placing a burden on some patients seeking this therapy.

Spinal Cord Stimulator Regulation History

Spinal cord stimulators are classified as Class III medical devices, a category that requires rigorous premarket approval and supplemental review when design or functional changes could affect safety or effectiveness.

Current lawsuits allege that manufacturers relied on PMA supplements and other expedited FDA approval pathways to market newer spinal cord stimulator models without sufficient clinical trials.

Plaintiffs also allege that manufacturers made substantial changes to these devices without submitting new Premarket Approval applications, even when those modifications materially affected safety profiles.

Some complaints go further, alleging that the FDA failed to meaningfully review supplemental approvals and allowed materially different devices to reach the market through a regulatory shortcut.

The scope of the issue has drawn added scrutiny because the FDA received more than 107,728 adverse event reports involving spinal cord stimulators over a four-year period, including more than 30,000 complaints of unsatisfactory pain relief.

Regulatory issues raised in spinal cord stimulator lawsuits include:

• Spinal cord stimulators entered the market as Class III medical devices subject to strict premarket review.
• Manufacturers allegedly used PMA supplements instead of new PMA applications for significant device changes.
• Plaintiffs allege those changes included substantial design and functional modifications affecting safety and effectiveness.
• Lawsuits claim supplemental approvals allowed successive generations of devices to reach patients without adequate new clinical testing.
• Some cases also allege inadequate preoperative planning, including failure to obtain necessary imaging before surgery.
• FDA adverse event data has become a major part of the broader scrutiny surrounding these devices.

Do You Qualify for a Spinal Cord Stimulator Lawsuit?

Injuries from spinal cord stimulators can have a profound impact on a person’s life, often turning a hopeful treatment into a daily struggle with new and worsening pain.

For many, these complications limit their mobility, add emotional strain, and affect their ability to work or care for loved ones.

The physical and emotional toll can be overwhelming, leaving individuals to navigate medical issues and the uncertainty of their well-being in the face of ongoing pain.

If you or a loved one has suffered injuries or complications from a spinal cord stimulator, you may be entitled to seek compensation for medical expenses, pain, and the impact on your quality of life.

Contact our law firm today for a free consultation.

Use the chat feature on this page for a free and instant case evaluation.

Attorneys handling injury claims related to spinal cord stimulators can help clients through the legal process, gathering evidence to support their case and assessing damages to understand the impact of the device.

Gathering Evidence for Spinal Cord Stimulator Litigation

Building a strong case for a Spinal Cord Stimulator Lawsuit requires gathering comprehensive evidence to demonstrate the impact of the device’s failure on the patient’s life.

Medical records documenting the initial pain condition, treatment attempts, and any complications post-implantation provide critical insight into the extent of harm caused.

Expert evaluations and personal documentation of pain levels, physical limitations, and emotional distress can strengthen the case, illustrating the profound effects of the injuries.

Evidence in a Spinal Cord Stimulator Lawsuit may include:

• Medical Records: Include documentation of the original pain diagnosis, details of the spinal cord stimulator procedure, and records of any complications or subsequent treatments.
• Device Information: Collect details on the specific model of the spinal cord stimulator, manufacturer, and any recall notices or reported issues associated with the device.
• Expert Medical Opinions: Obtain statements from healthcare professionals regarding the medical implications of the device’s failure and expected outcomes.
• Pain and Symptom Diary: Keep a daily record of pain levels, limitations in activities, and emotional or psychological impacts experienced.
• Employment Records: Show documentation of work limitations, lost income, or job changes due to physical complications from the device.
• Correspondence with Manufacturers or Healthcare Providers: Save any communication related to the device, including inquiries about risks, complaints, or service requests.

Damages in Spinal Cord Stimulator Injury Claims

In a legal context, “damages” refer to the compensation awarded to a plaintiff for the harm or losses they’ve suffered due to another party’s actions or negligence.

In Spinal Cord Stimulator injury claims, damages aim to address both the financial and non-financial impacts of the injuries, helping victims recover from the consequences of faulty devices.

These claims seek to cover not only direct costs, like medical bills, but also the broader effects on a person’s quality of life, earning capacity, and emotional well-being.

Potential damages in Spinal Cord Stimulator Lawsuits may include:

• Medical Expenses: Reimbursement for past, current, and future medical bills associated with the injuries, including surgeries, medications, physical therapy, and rehabilitation.
• Lost Wages and Earning Capacity: Compensation for income lost due to time off work and any reduction in earning ability caused by the injuries.
• Pain and Suffering: Damages for the physical pain endured from the injury, as well as emotional suffering such as anxiety, depression, or reduced enjoyment of life.
• Loss of Consortium: Compensation for the impact on relationships with family members and loved ones due to the physical and emotional effects of the injury.
• Punitive Damages: In some cases, additional damages may be awarded to punish the manufacturer for particularly egregious negligence or misconduct.
• Cost of Replacement or Removal: Compensation for costs related to replacing or removing the spinal cord stimulator if it was found to be defective or caused further harm.

TorHoerman Law: Investigating Spinal Cord Stimulators and Related Injury Claims

Spinal cord stimulators, intended to provide pain relief, have left some patients facing severe complications that worsen their condition and quality of life.

For some, device-related issues have led to irreversible damage and, tragically, even death.

Our attorneys are actively investigating spinal cord stimulator injury claims to support affected individuals and hold manufacturers accountable for these life-altering impacts.

If you or a loved one has experienced severe complications or injuries, or if you’ve lost someone due to a spinal cord stimulator, you may be eligible to pursue a legal claim to seek justice and compensation.

Contact TorHoerman Law for a free consultation.

Use the chat feature on this page to find out if you qualify for a Spinal Cord Stimulator Lawsuit instantly.