Spinal Cord Stimulator Risks, Injuries, and Complications

Spinal cord stimulator complications can occur during the trial period, during the initial procedure for permanent implantation, or after a spinal cord stimulator implant has been in place for months or years.

The implanted device uses leads positioned in the epidural space to deliver electrical stimulation that changes how pain signals are processed by the nervous system.

Spinal cord stimulation may be considered for some patients with chronic back pain, leg pain, persistent spinal pain syndrome, and other conditions when a pain management doctor determines that other treatment has not provided adequate relief.

Complications may involve the hardware, lead placement, the surgical procedure, or the body’s response to the implant.

Published literature has historically estimated overall complication rates around 30% to 40%, although rates vary considerably according to the device, implantation technique, follow-up period, and definition of an adverse event.

More recent research continues to find that device related complications, particularly problems involving leads and other hardware, occur more often than serious neurological injuries.

The associated risks range from temporary pain or uncomfortable stimulation to infection, bleeding, hardware failure, and complications requiring another operation.

Common spinal cord stimulator complications include:

• Lead migration: Stimulator leads can shift from their intended position after placement, changing where stimulation is delivered or reducing pain relief. Movement may occur during the trial period or after permanent implantation and can sometimes require reprogramming or revision.
• Lead fracture or connection problems: Leads can break, become damaged, or lose their connection to the pulse generator over time. These device-related complications may cause intermittent stimulation, loss of therapy, or changes in stimulation with movement.
• Device malfunction: Problems involving the pulse generator, charging system, battery, or connections can interfere with normal operation of the implanted device and may require additional evaluation or replacement.
• Uncomfortable stimulation: Improper stimulation settings, lead movement, or another device problem can cause a tingling sensation, jolting, shocks, or other uncomfortable sensations instead of the intended pain relief.
• Infection: Surgical site infections can develop around an incision, implanted lead, or generator pocket after spinal cord stimulator placement. Deeper infections involving the implanted hardware may require antibiotics and device removal.
• Dural puncture and cerebrospinal fluid leak: During minimally invasive lead placement, a needle can unintentionally puncture the dura surrounding the spinal cord. A resulting cerebrospinal fluid leak can cause a severe positional headache and may require additional treatment.
• Pain at the implant site: Many patients experience some postoperative discomfort, but persistent or severe pain around the generator pocket or lead site can become a longer-term complication requiring evaluation.
• Bleeding or hematoma: Bleeding can occur after implantation and, in rare cases, may form an epidural hematoma around the spinal cord. Compression from an epidural hematoma can cause serious neurological injury and requires prompt medical attention.

Reported rates differ substantially across the research, which is one reason individual study estimates should not be treated as universal complication rates.

A 2021 systematic review and meta-analysis of 32 studies found an average overall complication rate of 21.1%, including equipment-related complications in 12.1% of patients and medical complications in 6.3%, while a 2026 systematic review and meta-analysis found that 24% of patients experienced at least one adverse event and 3% experienced at least one serious adverse event.

Other research has reported biological complications in approximately 11.8% of implants in specific patient populations, illustrating how rates change according to the patients, devices, and outcomes being studied.

These findings describe complication patterns across groups of patients and do not predict whether a particular spinal cord stimulator patient will experience a problem.

How Spinal Cord Stimulator Complications Are Evaluated

A new symptom after spinal cord stimulator placement does not necessarily mean the implanted device has malfunctioned.

Returning chronic pain, changes in an underlying spinal condition, postoperative discomfort, lead movement, infection, stimulation settings, and hardware problems can produce similar symptoms.

Evaluation may involve a physical or neurological examination, imaging to assess lead position, and interrogation of the implanted system.

A pain management doctor may also review programming history to determine whether changes in stimulation settings correct unexpected sensations or restore pain relief.

The timing and nature of the symptoms can help determine what should be investigated.

Problems beginning shortly after the initial procedure may raise different concerns from a loss of stimulation, hardware problem, or return of pain developing months or years later.

Complications also vary significantly in severity.

The 2026 meta-analysis of spinal cord stimulation complications found lead migration occurred more frequently than infection and that revision procedures occurred more frequently than explantation, reinforcing the distinction between relatively common hardware problems and less frequent serious adverse events.

Most spinal cord stimulator problems involve the implanted hardware or complications associated with placement, but some adverse events can cause serious physical injury.

Neurological injuries are considerably less common than device-related complications, although their effects can be severe and sometimes lasting.

A review of spinal cord stimulator complications reported neurological injury rates ranging from approximately 0.03% to 0.25% in earlier studies, with higher rates reported in some later research.

Injury may result directly from needle or lead placement or indirectly when bleeding, infection, or another complication compresses or damages nervous tissue.

Symptoms can include new muscle weakness, sensory loss, severe pain, changes in bowel or bladder function, or paralysis.

These symptoms are different from the chronic pain conditions that led to treatment, such as spinal stenosis, diabetic neuropathy, or failed back surgery syndrome.

New neurological symptoms following implantation require medical evaluation to determine whether they are related to the spinal cord stimulator procedure or another condition.

Nerve Damage and Spinal Cord Injury

Nerve damage can occur if a needle, lead, or other surgical instrument directly injures nervous tissue during spinal cord stimulator placement.

Neurological injury can also develop later if an infection, epidural hematoma, scar tissue, or another complication places pressure on the spinal cord or nearby nerves.

A 2024 review of biological complications associated with spinal cord stimulation identifies nerve and spinal cord injury among the recognized biological complications of implantation.

Reported neurological effects can involve motor function, sensation, or autonomic function depending on the location and severity of the injury.

Patients may experience numbness, abnormal sensations, increasing pain, severe neck pain or back pain, muscle weakness, or difficulty controlling part of the body.

New symptoms can be particularly important when they differ from the pain or neurological problems that existed before implantation.

A patient’s preexisting diagnosis also matters when evaluating a possible spinal cord injury.

Someone who already has spinal stenosis, diabetic neuropathy, or persistent symptoms following failed back surgery syndrome may already feel pain, numbness, or weakness before receiving the device, so medical evaluation is needed to distinguish a new neurological deficit from the underlying condition.

Paralysis and Lasting Muscle Weakness

Severe spinal cord injury can interfere with signals controlling movement below the affected area.

Depending on the location and extent of the damage, a patient may develop muscle weakness, difficulty walking, loss of coordination, or partial or complete paralysis.

Neurological injury may result from direct trauma during implantation, but delayed injury can also occur when bleeding or infection compresses the spinal cord.

ASRA Pain Medicine notes that delayed neurological damage can occur following epidural hematoma or infection even when the initial lead placement does not directly damage the cord.

An epidural hematoma meta-analysis involving 4,751 spinal cord stimulation patients found neuraxial hematomas in approximately 0.32% of patients.

Although uncommon, bleeding in the confined epidural space can compress the spinal cord and create a risk of serious neurological injury.

Sudden or progressive muscle weakness, loss of sensation, or difficulty walking after spinal cord stimulator implantation may indicate a neurological emergency rather than an expected postoperative symptom.

Loss of Bowel or Bladder Function

Damage or compression affecting the spinal cord can interfere with the nerve pathways responsible for bladder and bowel function.

Patients may develop urinary retention, incontinence, loss of bowel control, or other changes in autonomic function when neurological injury affects these pathways.

A recent review of adverse events following spinal cord stimulator placement identified weakness, sensory loss, and sphincter dysfunction among the neurological symptoms reported after serious complications.

These deficits may occur alongside other signs of spinal cord compression, including severe pain or progressive muscle weakness.

Loss of bowel or bladder control after implantation is not a routine effect of spinal cord stimulation and may require urgent medical assessment.

The likelihood of recovery depends on the cause, severity, duration of compression or injury, and how quickly the underlying problem is treated.

Serious Injury From Deep Infection

Infection is a recognized complication of spinal cord stimulator implantation, but a deep infection can cause additional injuries when bacteria spread beyond the surgical site or implanted hardware.

The infection risk includes superficial wound infections as well as deeper infections involving the generator pocket, leads, epidural space, or surrounding tissue.

A 2025 review of neuromodulation device infections explains that deep infections can lead to sepsis and neurological injury and frequently require removal of the implanted system along with antimicrobial treatment.

Infection near the spine can become particularly serious if it affects the epidural space or produces compression of neural structures.

Patients with fever, drainage, increasing redness, severe pain, worsening weakness, or other signs of systemic illness after implantation may require prompt medical evaluation.

Although the overall infection risk is relatively low compared with mechanical device complications, the consequences of a deep infection can be substantially more serious than a localized surgical site infection

Additional surgery may be needed when a spinal cord stimulator complication cannot be corrected through reprogramming, medication, or other nonsurgical treatment.

Depending on the problem, surgery may involve revising part of the system or completely removing the permanent spinal cord stimulator.

Before a permanent implant is placed, many patients undergo a spinal cord stimulator trial using temporary leads to determine whether the electrical impulses provide effective pain relief.

Complications that develop after permanent implantation can involve the leads, generator, surrounding tissue, or surgical site and may require another procedure if symptoms persist or the implanted device can no longer function safely or effectively.

Situations that may lead to revision or removal include:

• Lead migration: Stimulator leads can move from their intended position after implantation. A 2021 systematic review and meta-analysis reported lead migration in 5.6% of patients, consistent with the approximately 4% to 7% range reported in some modern studies. When stimulator leads shift enough to reduce pain relief or cause unwanted stimulation, revision surgery may be needed to reposition or replace them.
• Lead fracture or connection failure: Damage to a lead or connection can interrupt the electrical impulses delivered by the system. Surgery may involve replacing the affected hardware while leaving the rest of the permanent spinal cord stimulator in place.
• Generator movement or device malfunction: Problems involving the pulse generator, battery, charging system, or connections may require repositioning or hardware replacement when reprogramming cannot restore normal function.
• Persistent loss of effective pain relief: Patients suffering from recurrent pain may first undergo device evaluation and reprogramming. If a correctable hardware problem is found, revision may be appropriate, while continued loss of benefit without a correctable cause may lead to consideration of device removal.
• Infection involving the implanted system: A multicenter study of 2,737 spinal cord stimulator implants reported an infection rate of 2.45%, consistent with commonly cited estimates of approximately 2.5% to 3%. Superficial infections may sometimes be treated without surgery, while deeper infections involving implanted hardware can require partial or complete removal of the system.
• Persistent pain caused by implanted hardware: Pain around the generator pocket or another implanted component may lead to repositioning when hardware placement is identified as the source. When pain continues despite revision or the device no longer provides sufficient benefit, complete removal may be considered.
• Serious neurological or surgical complications: Bleeding, spinal cord compression, nerve injury, or other severe complications may require urgent surgery to treat the injury and, in some cases, remove part or all of the spinal cord stimulator system.

Additional procedures are a recognized outcome after permanent spinal cord stimulator implantation.

In a study of 1,014 spinal cord stimulator procedures, 9.5% of patients underwent at least one reoperation.

Some patients may require additional surgeries for lead repositioning, hardware replacement, or complete device removal depending on the complication and whether the remaining system can continue to provide effective pain relief.

Revision and removal serve different purposes.

Revision attempts to correct a problem while preserving some or all of the permanent implant, whereas explantation removes the implanted system when infection, repeated hardware problems, loss of efficacy, or another complication makes continued use inappropriate.

Current spinal cord stimulator lawsuits raise product liability allegations involving device performance, federal regulatory requirements, product warnings, manufacturing, and manufacturer conduct.

The specific claims vary by company and device, which is one reason federal cases involving Boston Scientific, Abbott, and Nevro are now proceeding in separate manufacturer-specific multidistrict litigations.

Medtronic spinal cord stimulator lawsuits remain outside those coordinated proceedings.

The U.S. Judicial Panel on Multidistrict Litigation has described several recurring allegations in the federal cases, but the theories and supporting evidence are not identical across manufacturers.

Allegations raised in current spinal cord stimulator litigation include:

• Regulatory approval and PMA supplements: Plaintiffs in certain cases allege that manufacturers obtained initial premarket approval using published literature involving earlier spinal cord stimulation systems and later introduced substantially modified products through supplements to those original approvals. The JPML has described these allegations in explaining why common regulatory questions supported manufacturer-specific multidistrict litigation.
• Failure to warn: Some plaintiffs allege that manufacturers did not adequately disclose known risks associated with their devices or provide physicians and patients with sufficient information to evaluate those risks. The adequacy of the warnings and the information available at the relevant time remain disputed issues.
• Manufacturing and regulatory compliance: Certain lawsuits allege that spinal cord stimulator devices or manufacturing practices failed to comply with FDA-approved requirements or other federal regulations. Whether a particular device departed from approved specifications depends on the manufacturer, product, and evidence involved in the individual case.
• Manufacturer representative involvement: Plaintiffs in some cases, particularly the current Abbott spinal cord stimulator litigation, allege that company representatives participated in programming, reprogramming, or therapeutic adjustments to implanted systems without a physician present. The complaints characterize some of this conduct as the unauthorized practice of medicine.

These allegations have not been established merely because the cases were centralized into multidistrict litigation.

JPML transfer orders determine where related federal lawsuits will undergo coordinated pretrial proceedings; they do not decide whether a manufacturer is liable or whether the plaintiffs’ allegations are true.

The viability of an individual spinal cord stimulator lawsuit depends on the manufacturer and device involved, the alleged defect or regulatory violation, the patient’s injuries and treatment history, and the evidence connecting the alleged problem to the harm claimed.

Serious complications involving a spinal cord stimulator can lead to additional surgery, lasting pain, neurological injury, infection, or complete device removal.

When those problems may be connected to a defective device, inadequate warning, manufacturing issue, or other alleged manufacturer conduct, the circumstances may support an individual product liability claim.

TorHoerman Law is reviewing spinal cord stimulator lawsuits involving serious injuries and complications associated with devices made by Boston Scientific, Abbott, Nevro, Medtronic, and other manufacturers.

The viability of a claim depends on the device involved, the medical history, the complication or injury suffered, and the evidence connecting that harm to the implanted system.

If you or a loved one suffered serious complications after spinal cord stimulator implantation, contact a spinal cord stimulator injury lawyer at TorHoerman Law for a free consultation.

Qualifying cases are handled on a contingency fee basis, meaning there are no attorney fees unless our law firm recovers compensation for you.

You can also use the chat feature on this page for a free case review and to learn whether you may qualify to file a spinal cord stimulator lawsuit.