Nevro Spinal Cord Stimulator Lawsuit Overview

Spinal cord stimulator lawsuits allege that Nevro sold implanted pain devices that were not adequately tested or labeled for the risks associated with later generations of its spinal cord stimulation systems.

The complaints claim Nevro relied on the original FDA approval for its Senza spinal cord stimulator while later introducing updated devices, features and components through supplemental submissions. Plaintiffs allege these later Nevro systems included significant changes involving battery technology, firmware, waveform control, wireless communication, leads, user interfaces and programming capabilities.

According to the lawsuits, these were not minor updates. Plaintiffs claim the changes altered how Nevro spinal cord stimulators delivered therapy, how the devices were programmed and how they performed after implantation. The complaints allege patients and doctors were not given adequate warnings that later Nevro systems may carry risks involving unsafe stimulation, lead failure, device shutdown, loss of therapy, neurological injuries or complications that could require revision or removal surgery.

The lawsuits also raise concerns about Nevro representatives and device programming. Some plaintiffs claim company representatives programmed or reprogrammed devices outside the presence of a doctor, made therapeutic adjustments without meaningful physician supervision and told patients that painful symptoms could be corrected through additional programming when the symptoms may have reflected device failure or other serious problems.

Nevro Spinal Cord Stimulator Models Named in Lawsuits

Nevro spinal cord stimulator lawsuits are being investigated for individuals who suffered injuries after receiving any of the following Nevro SCS devices:

• Nevro Senza
• Nevro Senza II
• Nevro Senza Omnia
• Nevro HFX
• Nevro HFX iQ
• Nevro implanted pulse generators
• Nevro SCS leads and related components
• Other Nevro spinal cord stimulation systems

Nevro Spinal Cord Stimulator Lawsuit Status

Nevro spinal cord stimulator lawsuits are being reviewed and filed as individual personal injury claims for patients who suffered serious complications after receiving a Nevro SCS device.

At this time, there is not a Nevro spinal cord stimulator class action lawsuit or multidistrict litigation that includes all claims against Nevro. Instead, cases are being pursued separately based on each patient’s injuries, the device involved, where the implant surgery occurred and the medical treatment required after complications developed.

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

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

How Inadequately Tested Nevro SCS Features Reached Patients

A central issue in Nevro spinal cord stimulator lawsuits involves how updated devices and features allegedly reached patients without adequate clinical validation.

Plaintiffs claim Nevro expanded its spinal cord stimulation platform through a series of supplemental approvals, rather than conducting a full new safety review for each redesigned system. The lawsuits allege later Nevro devices included substantial updates to firmware, waveform control, wireless communication, leads, battery features and programming functions.

These changes matter because spinal cord stimulators depend on precise electrical output, accurate programming and properly positioned leads. If a device delivers stimulation incorrectly, loses communication, shuts down, migrates or fails to provide therapy, patients may experience painful shocks, burning sensations, worsening nerve pain, loss of mobility or other serious complications.

The lawsuits allege Nevro failed to adequately warn patients and doctors that later generations of its SCS systems may perform differently than the original device and may carry risks that were not fully evaluated through long term clinical testing.

Permanent Nevro Implant Did Not Work Like the Trial Version

Many patients receive a temporary spinal cord stimulator trial before agreeing to a permanent implant. The trial is intended to show whether stimulation may provide enough pain relief to justify surgery.

Some Nevro lawsuits allege patients were told the permanent implant would provide pain relief similar to the trial device. However, plaintiffs claim the permanent Nevro system later failed to perform as represented, resulting in:

• Worsening pain
• Electrical shocks
• Burning pain
• Loss of stimulation coverage
• Pain relief that quickly faded
• Stimulation in the wrong area
• Weakness, numbness or walking problems
• Repeated reprogramming without lasting improvement
• Revision or removal surgery

Lawsuits allege Nevro failed to adequately disclose that the permanent device may not perform like the trial, especially when later systems included updated programming features, wireless communication, firmware or stimulation settings.

Therapy Shutoff, Wireless Programming and Reprogramming Problems

Nevro spinal cord stimulator lawsuits also raise concerns about programming and device control problems after implantation.

The complaints allege that some Nevro devices experienced therapy interruptions, wireless communication failures, battery or charging issues, stimulation problems and repeated programming failures. Plaintiffs claim these problems caused loss of therapy, painful stimulation, worsening symptoms or the need for additional medical treatment.

Some lawsuits also allege that Nevro representatives became directly involved in reprogramming the device after patients complained about painful symptoms. Plaintiffs claim representatives adjusted stimulation settings, gave guidance about continued use or suggested additional reprogramming, even when the symptoms may have indicated lead failure, device migration or unsafe stimulation.

Potential signs of a programming or communication problem may include:

• The device shuts down or stops delivering therapy
• The controller cannot communicate with the implant
• Charging problems interfere with therapy
• Stimulation becomes painful after settings are changed
• Reprogramming provides only temporary relief
• The device repeatedly needs adjustment
• Symptoms worsen after programming visits
• A Nevro representative adjusts settings without a doctor present

Lawsuits allege that repeated reprogramming may have delayed proper medical evaluation for some patients, causing them to continue using devices that were not functioning safely or effectively.

Nevro Spinal Cord Stimulator Side Effects

Nevro spinal cord stimulator lawsuits involve a range of complications allegedly caused by defective devices, inadequate warnings, programming failures or unsafe stimulation. Reported problems include:

• Electrical shocks
• Overstimulation
• Burning pain
• Worsening nerve pain
• Loss of therapy
• Stimulation in the wrong area
• Lead migration
• Lead wire problems
• Battery or charging failure
• Device shutdown
• Wireless communication failure
• Weakness or numbness
• Difficulty walking
• Falls or balance problems
• Urinary retention or incontinence
• Bowel dysfunction
• Swallowing problems
• Revision surgery
• Device removal surgery
• Permanent nerve damage

Not every complication after implantation will support a lawsuit. However, symptoms may be relevant if they developed after a Nevro implant, worsened after reprogramming, continued despite repeated adjustments or required revision or removal surgery.

Nevro Representatives Reprogrammed SCS Devices

Nevro representatives may provide technical support for spinal cord stimulation systems. However, lawsuits allege some company representatives went beyond technical support and became involved in patient care.

Some plaintiffs claim Nevro representatives participated in programming visits, adjusted stimulation settings, responded to patient complaints and made statements about whether symptoms could be fixed through additional programming. The complaints allege some of these activities occurred outside the presence of a doctor or without meaningful physician supervision.

This may be important to a potential claim if a Nevro representative:

• Told you the permanent implant would work like the trial
• Programmed or reprogrammed your device
• Adjusted stimulation settings during a follow-up visit
• Met with you without your doctor present
• Told you shocks, burning pain or worsening symptoms were only a settings issue
• Told you to continue using the device despite painful complications
• Participated in repeated programming visits without lasting improvement

Lawsuits allege patients and doctors may have made different treatment decisions if Nevro had provided complete information about device risks, programming limitations and potential signs of device failure.

Allegations Raised in Nevro SCS Lawsuits

Nevro spinal cord stimulator lawsuits raise several legal claims based on allegations that the company sold implanted pain devices without adequate testing or warnings. Potential claims may include:

• Failure to warn: Nevro allegedly failed to warn doctors and patients about risks involving shocks, overstimulation, lead failure, device migration, loss of therapy, neurological injuries, bowel or bladder problems and removal surgery.
• Design or manufacturing defect: Plaintiffs allege Nevro SCS systems were defective because later devices included changes to firmware, battery features, waveform control, wireless communication, leads and programming capabilities without adequate safety testing.
• Negligence: Plaintiffs claim Nevro failed to use reasonable care when designing, testing, manufacturing, marketing, monitoring and supporting its spinal cord stimulation systems.
• Failure to investigate or report adverse events: Nevro allegedly failed to properly investigate, document or disclose reports involving device failure, stimulation problems, lead migration, loss of therapy and worsening neurological symptoms.
• Misrepresentation: Plaintiffs allege Nevro promoted its spinal cord stimulators as safe and effective for long term pain relief while failing to disclose material risks and device problems.
• Improper involvement of Nevro representatives: Some lawsuits allege Nevro representatives adjusted settings, participated in programming decisions or gave treatment related guidance without proper medical authority.

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

Evidence To Support a Nevro Spinal Cord Stimulator Lawsuit

A Nevro spinal cord stimulator claim may depend on showing what device was implanted, how it performed after surgery, what symptoms developed and whether company representatives were involved in programming or reprogramming the device. Useful records may include:

• Implant records identifying the Nevro pulse generator, leads and related components
• Device card, model number, serial number or product labels
• Records from the temporary SCS trial
• Records showing whether the permanent implant worked like the trial
• Pain management notes before and after implantation
• Programming and reprogramming records
• Records showing whether Nevro representatives attended appointments
• Communications with Nevro representatives about shocks, pain, charging problems or loss of therapy
• Notes documenting complaints of burning pain, overstimulation or worsening symptoms
• Records showing battery depletion, charging failure, device shutdown or communication problems
• Imaging or physician notes showing lead migration or device movement
• Neurology, urology or emergency room records after new symptoms developed
• Records showing urinary, bowel, walking or balance problems after implantation
• Revision surgery records
• Device removal surgery records

These records may help determine whether the injury involved inadequate warnings, device failure, lead movement, programming problems, battery or charging failure or improper involvement by Nevro representatives.

Contact Our Nevro SCS Lawyers

The Nevro spinal cord stimulator lawyers at Saiontz & Kirk can review whether your injuries may be linked to device failure, inadequate warnings, repeated reprogramming or the involvement of Nevro representatives after implantation.

These claims often depend on more than the fact that a stimulator did not provide pain relief. Important facts may include:

• The date your Nevro SCS device was implanted
• The specific Nevro model used
• Whether Senza, Senza II, Senza Omnia, HFX, HFX iQ or another Nevro system was involved
• Whether the permanent implant performed like the trial
• Symptoms that developed after implantation
• Whether you experienced shocks, burning pain, overstimulation or loss of therapy
• Whether you developed weakness, numbness, walking problems, bowel problems or bladder problems
• Reprogramming visits involving Nevro 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 Nevro 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 Nevro 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.

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