Medtronic Spinal Cord Stimulator Lawsuit Overview

Saiontz & Kirk is filing Medtronic spinal cord stimulator lawsuits for individuals who suffered serious complications after receiving an implanted Medtronic SCS device for chronic pain.

Spinal cord stimulator lawsuits claim that Medtronic continued using an original FDA approval from 1984, while introducing newer generations of devices with different batteries, leads, firmware, wireless programming features, charging systems and stimulation settings, all of which were not adequately tested for safety before being implanted in patients.

According to allegations raised in the complaints, Medtronic knew or should have known that programming changes and device failures could create new risks for patients, but failed to adequately investigate adverse event reports or warn about complications, including painful electrical shocks, overstimulation, burning pain, worsening nerve pain, battery problems, charging failures, loss of therapy, device migration and the need for revision or removal surgery.

Many Medtronic lawsuits also allege that company representatives were allowed to play an improper role in patient treatment after the devices were implanted. Some complaints claim Medtronic representatives adjusted pain relief settings during programming visits without proper physician consent or supervision, despite lacking medical degrees or authority to make treatment decisions.

Medtronic Spinal Cord Stimulator Models Named in Lawsuits

Medtronic spinal cord stimulator lawsuits are being investigated for individuals who received any of the following devices:

• Intellis
• Intellis LT
• Restore
• RestoreAdvanced
• PrimeAdvanced
• RestoreSensor
• Synergy
• Vectris leads
• SureScan MRI systems
• Inceptiv
• Other Medtronic spinal cord stimulation systems

Medtronic Spinal Cord Stimulator Lawsuit Status

Medtronic spinal cord stimulator lawsuits are actively being filed as individual personal injury claims for people who suffered complications after receiving an implanted SCS device.

At this time, there is no Medtronic spinal cord stimulator class action lawsuit or multidistrict litigation that includes all claims against Medtronic. Instead, cases are being filed in the courts that apply to each injured patient’s claim.

The proper filing court may depend on the Medtronic device model implanted, the date of implantation, the state where the surgery occurred, the complications that developed after implantation, whether the device was reprogrammed, turned off, revised or removed, and the medical treatment required after the device failed or caused injuries.

Claims involving other spinal cord stimulator manufacturers are being reviewed and pursued separately. For more information about lawsuits involving other SCS device makers, see:

• Boston Scientific Spinal Cord Stimulator Lawsuits
• Abbott/St. Jude Spinal Cord Stimulator Lawsuits
• Nevro Spinal Cord Stimulator Lawsuits

To find out how to proceed with your potential Medtronic spinal cord stimulator lawsuit, request a free consultation with a spinal cord stimulator lawyer today.

Medtronic SCS Controversial Market Approval

A key issue in the Medtronic spinal cord stimulator litigation involves the way newer SCS devices reached the market.

Lawsuits allege Medtronic obtained FDA premarket approval for its original spinal cord stimulator system in 1984. Plaintiffs claim the company later used that original approval as the foundation for newer devices that had substantially different components, software, batteries, leads, charging systems and stimulation features.

The complaints allege Medtronic introduced these changes through repeated FDA supplement approvals, rather than submitting a new premarket approval application for devices that allegedly had different safety and performance risks.

Plaintiffs claim this allowed Medtronic to avoid the level of clinical testing, public review and updated safety analysis that should have been required for newer generations of implanted spinal cord stimulators.

Saiontz & Kirk is investigating whether Medtronic failed to properly disclose that newer SCS systems were materially different from the original device reviewed by the FDA and whether patients were implanted with devices that lacked adequate clinical validation.

Medtronic Spinal Cord Stimulators Problems

Problems reported in Medtronic spinal cord stimulator lawsuits include electrical shocks, overstimulation, burning pain, loss of therapy, battery or charging failures, lead migration, neurological symptoms, bowel or bladder problems and the need for revision or removal surgery.

Electrical Shocks and Overstimulation

Electrical shocks and overstimulation are among the most commonly reported problems in Medtronic spinal cord stimulator lawsuits. Individuals may experience sudden jolts, burning sensations or stimulation that feels too strong, spreads to the wrong area or becomes painful during normal movement.

Symptoms and complications may include:

• Sudden electrical shocks
• Jolting or zapping sensations
• Burning pain
• Overstimulation
• Painful stimulation in the legs, back or buttocks
• Muscle twitching or shaking
• Worsening nerve pain
• Difficulty sleeping or walking
• Fear of using the device

Lawsuits allege these symptoms may be caused by device defects, programming failures, lead problems or stimulation settings that deliver unsafe electrical impulses.

Loss of Therapy or Failed Pain Relief

Loss of therapy occurs when a spinal cord stimulator stops providing meaningful pain relief or no longer covers the area it was intended to treat. Patients may be left with worsening chronic pain, while also dealing with complications caused by the implanted device.

Symptoms and complications may include:

• Return of severe pain
• Worsening back, neck or leg pain
• Loss of stimulation coverage
• Stimulation in the wrong area
• No meaningful pain relief after implantation
• Repeated reprogramming without improvement
• Device shutdown
• Reduced mobility
• Need for revision or removal surgery

Lawsuits allege some Medtronic spinal cord stimulators failed to work as represented or lost effectiveness after implantation. Plaintiffs claim these failures may be linked to lead migration, programming issues, battery problems, device defects or inadequate warnings about the risk of therapy failure.

Battery and Charging Problems

Battery and charging problems may cause a Medtronic spinal cord stimulator to lose power, stop delivering stimulation or become difficult to use as intended. These issues may be especially serious for patients who rely on the device for daily pain control.

Symptoms and complications may include:

• Rapid battery depletion
• Difficulty charging the device
• Charging failure
• Device not holding a charge
• Loss of stimulation when the battery drains
• Sudden device shutdown
• Nonfunctional device
• Repeated medical visits for troubleshooting
• Need for replacement or removal surgery

Lawsuits allege Medtronic failed to adequately warn about battery, charging and power management problems involving certain spinal cord stimulation systems. Plaintiffs claim these failures caused patients to lose pain relief, undergo repeated reprogramming and, in some cases, require additional surgery.

Lead Migration and Device Movement

Lead migration occurs when the electrical leads placed near the spinal cord move from their intended position. Device movement may also involve shifting of the implanted pulse generator or related components.

Symptoms and complications may include:

• Loss of pain relief
• Stimulation in the wrong area
• New or worsening pain
• Electrical shocks
• Numbness or tingling
• Weakness
• Difficulty walking
• Pain at the implant site
• Need for lead revision surgery
• Need for device removal surgery

Lawsuits allege Medtronic failed to adequately warn about lead migration, device movement and related complications. Plaintiffs claim that when the leads move, the device may stop treating the targeted pain area or deliver stimulation to unintended parts of the body.

Neurological, Bowel and Bladder Problems

Some Medtronic spinal cord stimulator lawsuits involve neurological symptoms or changes in bowel and bladder function after implantation. These complications may be especially serious because they can affect mobility, independence and quality of life.

Symptoms and complications may include:

• Lower extremity weakness
• Numbness or tingling
• Difficulty walking
• Loss of balance
• Shaking or abnormal leg movements
• New nerve pain
• Urinary incontinence
• Bladder dysfunction
• Bowel dysfunction
• Permanent nerve damage

Lawsuits allege these complications may be linked to overstimulation, unintended stimulation, lead movement, programming problems or other device failures. Plaintiffs claim Medtronic failed to adequately warn patients and doctors that spinal cord stimulator problems could cause or worsen neurological, bowel or bladder symptoms.

Revision Surgery or Device Removal

Many Medtronic spinal cord stimulator lawsuits involve patients who required additional procedures after the device failed, malfunctioned or caused painful complications. Some patients have the device turned off first, while others eventually require revision surgery or complete explant surgery.

Reasons for revision or removal may include:

• Painful electrical shocks
• Burning pain or overstimulation
• Loss of therapy
• Battery or charging failure
• Lead migration
• Device migration
• Infection
• Persistent implant site pain
• Failed reprogramming
• Worsening neurological symptoms

Revision or removal surgery may involve additional pain, recovery time, medical expenses and surgical risks. In some cases, patients continue to suffer pain, nerve symptoms or mobility limitations even after the device is removed.

Medtronic Sales Representatives and Patient Programming

Many Medtronic spinal cord stimulator lawsuits raise concerns about the company’s field representatives and their involvement in patient care.

The complaints allege Medtronic representatives were often present during implant procedures, trial procedures, programming visits and follow up appointments. Plaintiffs claim some representatives adjusted stimulation settings, gave programming guidance, answered patient complaints and acted as technical authorities in the clinical setting.

Saiontz & Kirk is investigating claims that Medtronic representatives may have crossed the line from device support into treatment decisions, despite not being licensed medical providers.

Lawsuits allege this conduct caused patients to rely on company employees for safety information and programming guidance, while Medtronic failed to disclose known problems with the devices.

If a Medtronic representative adjusted your spinal cord stimulator, told you to keep using the device despite painful symptoms or repeatedly reprogrammed the device without lasting improvement, that information may be important to your potential lawsuit.

Do I Need the Device Removed to File a Medtronic SCS Lawsuit?

You may still have a potential Medtronic spinal cord stimulator lawsuit even if the device has not been removed.

Some claims involve patients who still have the device implanted but suffered electrical shocks, burning pain, overstimulation, loss of therapy, neurological symptoms or repeated programming failures. Other cases involve patients who had the device:

• Turned off
• Reprogrammed multiple times
• Revised
• Replaced
• Surgically removed

Removal surgery may strengthen a claim in some cases, but it is not always required. Our lawyers can review your medical records and determine whether your complications may support a Medtronic SCS lawsuit.

Allegations Raised in Medtronic Spinal Cord Stimulator Lawsuits

Medtronic spinal cord stimulator lawsuits raise several legal claims based on allegations that the company sold implanted pain devices that were defectively designed, inadequately tested and marketed without complete warnings about serious risks.

The specific claims may vary depending on the patient’s injuries, device model, filing state and available evidence, but may include:

• Failure to warn: Medtronic allegedly failed to warn doctors and patients about risks involving shocks, overstimulation, battery problems, lead migration, loss of therapy, neurological injuries and removal surgery.
• Manufacturing and design defect: Plaintiffs allege Medtronic SCS systems were defectively designed because newer devices added batteries, firmware, wireless programming, charging systems and stimulation features without adequate safety testing.
• Negligence: Plaintiffs allege Medtronic failed to use reasonable care when designing, testing, marketing, monitoring and supporting its spinal cord stimulation systems.
• Failure to report adverse events: Medtronic allegedly failed to properly investigate, document or report patient complaints involving shocks, overstimulation, battery failure, loss of therapy and worsening symptoms.
• Misrepresentation: Plaintiffs allege Medtronic promoted its spinal cord stimulators as safe, effective and reliable while failing to disclose material risks and device problems.
• Breach of express warranty: Plaintiffs allege Medtronic’s devices failed to perform as promised despite representations about safety, effectiveness, reliability and long term pain relief.
• Breach of implied warranty: Lawsuits claim Medtronic SCS systems were not reasonably fit for their intended purpose because they failed to relieve pain or caused serious complications.
• Consumer protection violations: Some claims allege Medtronic used misleading marketing or promotional statements about the safety, testing, reliability or regulatory status of its devices.
• Improper involvement of Medtronic representatives: Some lawsuits allege Medtronic field representatives adjusted settings, participated in programming decisions or gave device related guidance without proper medical authority.

The lawsuits generally allege that patients and doctors may have chosen a different treatment, delayed implantation or pursued removal sooner if Medtronic had provided complete information about the risks and limitations of its spinal cord stimulation systems.

What Compensation May Be Available?

A Medtronic spinal cord stimulator lawsuit may seek financial compensation for injuries and losses caused by device complications. Potential damages may include:

• Medical expenses
• Future medical care
• Revision surgery costs
• Device removal surgery costs
• Pain and suffering
• Emotional distress
• Lost income
• Reduced ability to work
• Loss of mobility
• Loss of enjoyment of life
• Permanent injury
• Disability
• Wrongful death damages for surviving family members

The value of a Medtronic SCS lawsuit will depend on several factors, including the severity of the injury, whether surgery was required, how long the device remained implanted, the impact on daily life and the medical evidence linking the complications to the device.

Medtronic Spinal Cord Stimulator Lawsuit Evidence

A Medtronic spinal cord stimulator claim often depends on showing what device was implanted, how the device performed after surgery and whether the complications match the failure patterns alleged in current lawsuits.

These cases may require more than a simple diagnosis or statement that the stimulator did not work. Important evidence may show the device model, the leads used, the programming history, the role of Medtronic representatives and the medical reason the device was revised, deactivated or removed. Useful records may include:

• Implant records identifying the Medtronic pulse generator, leads and related components
• Device card, device stickers, model numbers, serial numbers or product labels
• Operative report from the permanent implant surgery
• Records from the temporary SCS trial and whether the trial worked differently than the permanent implant
• Pain management notes before and after implantation
• Programming records showing repeated changes to stimulation settings
• Records showing Medtronic representatives attended programming or follow-up appointments
• Communications with Medtronic representatives about shocks, pain, charging problems or loss of therapy
• Notes documenting complaints that the device was shocking, overstimulating or causing pain in new areas
• Records showing battery depletion, charging failure, device shutdown or inability to hold a charge
• Imaging or physician notes showing lead migration, lead problems or device movement
• Neurology, urology or emergency room records after new symptoms developed
• Records documenting leg weakness, shaking, numbness, difficulty walking or falls
• Records showing urinary incontinence, bladder dysfunction or bowel problems after implantation
• Records showing the device was turned off because of complications
• Revision surgery records
• Explant surgery records
• Records showing ongoing pain, mobility problems, nerve damage or loss of quality of life after removal

These records may help determine whether the injury involved a device malfunction, failed therapy, lead movement, programming problems, battery or charging failure, or complications that continued despite Medtronic involvement.

How Our Medtronic Spinal Cord Stimulator Lawyers Can Help

To evaluate a potential Medtronic spinal cord stimulator lawsuit, Saiontz & Kirk will review the facts that connect the implant to the injuries and medical treatment that followed, which may include:

• The date your Medtronic SCS device was implanted
• The specific Medtronic model used
• Whether Intellis, Restore, PrimeAdvanced, RestoreSensor, Vectris leads or another Medtronic system was involved
• Symptoms that developed after implantation
• Whether you experienced shocks, burning pain, overstimulation or loss of therapy
• Medical treatment after the complications began
• Reprogramming visits involving Medtronic representatives
• Whether the device was turned off, revised or removed
• The long term impact on your health, mobility and quality of life

If you or a loved one suffered injuries after receiving a Medtronic spinal cord stimulator, contact Saiontz & Kirk today.

Call 1-800-522-0102 or complete the form on this page to find out whether you may qualify for a Medtronic spinal cord stimulator lawsuit.

All cases are handled on a contingency fee basis, which means there are no fees or expenses unless we win your case.

FIND OUT IF YOU QUALIFY FOR A MEDTRONIC SPINAL CORD STIMULATOR LAWSUIT