Spinal cord stimulators are used to treat chronic pain, but some patients later experience infections, nerve damage, painful stimulation, device migration, or complications requiring revision or removal surgery.
Potential spinal cord stimulator cases may involve product liability claims against manufacturers, medical malpractice claims against healthcare providers, or both.
Product liability claims may allege design or manufacturing defects, inadequate testing, hardware failures, or insufficient warnings about known risks within the medical device industry.
Medical malpractice claims may involve improper lead placement, surgical injury, poor infection control, programming errors, or inadequate follow-up care.
A patient’s eligibility generally depends on four questions:
- Was a spinal cord stimulator implanted?
- Did the patient develop a documented injury or complication?
- Do medical records connect the harm to the device or implantation procedure?
- Was the claim filed within the applicable legal deadline?
A device that did not provide sufficient pain relief is not necessarily defective.
Stronger claims generally involve objective evidence of defective spinal cord stimulator complications, such as lead migration, abnormal stimulation, hardware failure, infection, or additional surgery.
Types of Spinal Cord Stimulator Injuries and Their Causes
Spinal cord stimulators are intended to reduce chronic pain by delivering electrical stimulation near the spinal cord, but complications may arise from the implantation procedure, the device hardware, or the system’s long-term performance.
Published medical literature has estimated that approximately 30% to 40% of spinal cord stimulation patients experience some form of complication.
Reported rates vary by device, surgical technique, follow-up period, patient population, and the definition used, and not every complication results in a lawsuit.
Recognized surgical complications include infection, bleeding, dural puncture, and injury to nerves or tissue near the spinal canal.
Hardware problems may develop when a lead migrates, fractures, disconnects, or stops delivering stimulation as programmed.
Lead migration can reduce or eliminate pain relief, direct stimulation to the wrong area, and require surgery to reposition or replace the lead.
Lead wire fractures may cause device failure, intermittent stimulation, worsening pain, or complete loss of therapy.
Patients have also reported painful electrical shocks, burning sensations, continuing nerve pain, weakness, and other neurological symptoms after implantation.
The most serious reported outcomes include permanent nerve damage, paralysis, bowel or bladder dysfunction, and other spinal cord injuries.
An analysis of FDA data identified more than 80,000 injury reports involving spinal cord stimulators beginning in 2008.
FDA adverse-event reports can identify possible spinal cord stimulator risks, but individual reports do not independently prove that a device was defective, caused an injury, or created legal liability.
Common spinal cord stimulator injuries and complications include:
- Lead Migration or Dislodgment – Implanted leads may shift from their intended position, causing loss of pain relief, stimulation in an unintended area, worsening symptoms, or the need for revision surgery.
- Lead Wire Fracture or Disconnection – A damaged or disconnected lead may interrupt therapy, cause inconsistent stimulation, or result in complete device failure.
- Abnormal Device Behavior – Inconsistent, unintended, or painful stimulation may cause sudden discomfort, muscle contractions, burning sensations, or painful electrical shocks.
- Nerve Damage or Neurological Injury – Lead placement, migration, bleeding, compression, or abnormal stimulation may contribute to numbness, weakness, loss of sensation, continuing nerve pain, or paralysis.
- Infection – Infection may develop at the incision, lead, or pulse-generator site and require antibiotics, hospitalization, revision surgery, or complete explantation.
- Epidural Hematoma or Bleeding – Bleeding in or near the epidural space can place pressure on the spinal cord or nerve roots, potentially causing severe pain, weakness, sensory loss, or permanent neurological damage.
- Dural Puncture and Cerebrospinal Fluid Leak – Accidental puncture of the membrane surrounding the spinal cord may cause severe spinal headaches, nausea, dizziness, or additional treatment.
- Battery or Pulse-Generator Failure – Battery depletion, charging problems, software errors, or generator malfunction may interrupt stimulation and require surgical replacement.
- Burns or Tissue Damage – Electrical malfunction, overheating, or abnormal energy delivery may cause internal burns, skin injury, or damage to tissue surrounding the implanted components.
- Loss of Pain Relief or Worsening Pain – Some patients experience reduced therapy, new pain, or worsening symptoms after the system migrates, fractures, malfunctions, or becomes difficult to program.
- Bowel or Bladder Dysfunction – Serious neurological injury or spinal cord compression may interfere with bowel or bladder control and require emergency medical treatment.
- Multiple Surgeries or Explantation – Patients may undergo repeated lead revisions, generator replacement, infection treatment, or complete removal of the spinal cord stimulator.
The presence of a complication does not automatically establish that the device manufacturer or healthcare provider is legally responsible.
Product liability lawsuits may allege that safer design, testing, manufacturing controls, or warnings could have reduced the risk of injury.
Medical malpractice claims may instead involve allegations of improper lead placement, inadequate infection prevention, surgical injury, or failure to respond appropriately when complications developed.
Medical records, imaging, device interrogation reports, programming history, and findings from revision or explant surgery may help determine whether a complication resulted from the device, the implantation procedure, the underlying condition, or another cause.
If you or a loved one has suffered severe injuries from a spinal cord stimulator, legal action through a defective medical device lawsuit or medical malpractice claim may be an option to hold the responsible parties accountable and seek compensation for your losses.
