Nevro Spinal Cord Stimulator Lawsuit

Nevro Corporation revolutionized the industry with its HF10 and HFX spinal cord stimulation devices, introducing groundbreaking 10 kHz high-frequency technology that promised pain relief without the tingling sensations traditionally associated with these systems.

These FDA-approved devices were marketed as superior alternatives for managing chronic back pain, leg pain, diabetic neuropathy, Complex Regional Pain Syndrome, failed back surgery syndrome, and other debilitating conditions.

The company’s proprietary technology operates at 10,000 Hz, dramatically different from conventional low-frequency stimulators that typically function below 1,200 Hz.

This section examines the technology, regulatory approvals, and market positioning of these devices that have now become the subject of serious legal concerns.

How Do the Nevro HF10 and HFX Spinal Cord Stimulator Work?

Nevro’s spinal cord stimulation technology represents a fundamental departure from traditional pain management devices through its unique high-frequency approach.

The HF10 and HFX systems deliver electrical pulses at 10,000 Hz directly to the spinal cord, interrupting pain signals before they reach the brain through low amplitude (1-5 mA) and short pulse width (30 μS) parameters.

Unlike conventional stimulators that create paresthesia (a tingling or buzzing sensation that masks pain) Nevro’s technology targets inhibitory neurons in the dorsal horn to provide pain relief without any sensation.

The implantation process requires several key components and stages:

• Initial spinal cord stimulator trial period lasting 3-7 days with temporary leads to assess effectiveness
• The spinal cord stimulator procedure requires permanent implantation with surgical placement of thin insulated wires (leads) near the spinal cord
• Implantable pulse generator (IPG) placement, typically in the buttock or abdomen area
• External remote control for patient-controlled therapy adjustments
• Rechargeable spinal cord stimulators require regular charging sessions

Clinical studies, particularly the pivotal SENZA-RCT trial published in Anesthesiology journal, demonstrated that HF10 therapy achieved superior outcomes compared to traditional spinal cord stimulation.

The study reported that 84.5% of back pain patients and 83.1% of leg pain patients experienced significant pain relief with HF10 therapy, compared to only 43.8% and 55.5% respectively with traditional SCS.

The paresthesia-free feature was considered revolutionary because it allowed patients to drive, sleep, and perform daily activities without the constant tingling sensation that many found uncomfortable or limiting.

The device’s rechargeable battery system was designed to last 10-25 years, considerably longer than non-rechargeable alternatives that require replacement every 3-5 years.

This longevity, combined with the promise of superior pain relief without side effects, made Nevro’s technology particularly attractive to patients seeking long-term solutions to manage chronic pain.

FDA Regulatory History and Approval Process

The path to market for Nevro’s spinal cord stimulators involved rigorous evaluation through multiple clinical trials and the FDA’s Premarket Approval (PMA) process, the most stringent regulatory pathway for Class III medical devices implanted in patients.

The FDA classifies spinal cord stimulators as Class III devices, requiring manufacturers to demonstrate safety and effectiveness through extensive clinical trials before marketing.

Nevro received initial FDA approval for its Senza system in May 2015, marking the first high-frequency spinal cord stimulator authorized for use in the United States.

The landmark SENZA-RCT (Randomized Controlled Trial) study served as the cornerstone for FDA approval, involving 198 patients across multiple centers who were randomized to receive either HF10 therapy or traditional low-frequency stimulation.

The results showed not only superior pain relief but also a favorable safety profile, with no reports of neurological deficits directly attributable to the stimulation.

This evidence convinced FDA reviewers that the novel 10 kHz frequency posed no additional risks compared to conventional devices.

Subsequent FDA approvals substantially expanded Nevro’s market reach:

• July 2021: FDA approval for treating painful diabetic neuropathy (PDN), making it the first spinal cord stimulation system authorized for this indication
• October 2022: Approval of the HFX iQ system incorporating artificial intelligence to personalize therapy
• Multiple supplemental approvals for enhanced features and expanded MRI compatibility

However, the broader spinal cord stimulator industry has faced increasing scrutiny from regulators.

While the FDA has not issued a specific safety communication regarding Nevro devices, the agency has raised concerns about spinal cord stimulators generally.

Medical device industry data reveals troubling patterns, with tens of thousands of adverse event reports filed annually for various manufacturers’ devices.

These reports document issues ranging from device malfunctions to serious neurological injuries, highlighting the gap between clinical trial results and real-world outcomes.

The FDA’s medical device reporting system continues to monitor post-market safety data, requiring manufacturers to report serious adverse events.

This ongoing surveillance has revealed that complications may be more common than initially understood, raising questions about whether medical device manufacturers adequately captured long-term risks in pre-market trials.

Market Position and Competition in the Spinal Cord Stimulation Industry

Nevro established itself as a major player in the global spinal cord stimulation market, competing against burst stimulation devices and other technologies through aggressive marketing of its proprietary 10 kHz approach.

The company’s HF10 and HFX systems competed directly with dorsal root ganglion stimulators, Infinity deep brain stimulators, and devices from Boston Scientific, Abbott, and Medtronic in a market experiencing growth driven by the chronic pain epidemic.

Industry analysts estimate the global spinal cord stimulation market exceeded $2.5 billion in recent years, with projections for continued expansion as more patients seek alternatives to opioid medications.

Nevro differentiated itself from competitors through several strategic advantages:

• Paresthesia-free therapy as the primary advantage over traditional systems
• Superior clinical outcomes based on the SENZA-RCT study data
• Advanced features including full-body MRI compatibility
• Longest-lasting rechargeable battery technology in the industry
• Proprietary waveform parameters protected by extensive patent portfolio

The competitive landscape intensified through patent disputes, most notably with Boston Scientific, which alleged that Nevro infringed on its spinal cord stimulation technology patents.

These legal battles culminated in settlements and cross-licensing agreements, demonstrating the high stakes involved in controlling innovative pain management technologies.

The patent disputes also revealed the substantial investments companies make in developing and protecting their intellectual property in this lucrative market.

Marketing materials heavily promoted Nevro’s devices as revolutionary solutions that could relieve pain and “liberate” patients from chronic conditions, using patient testimonials and clinical data to support superiority claims.

The company’s direct-to-consumer advertising campaigns featured messages about regaining active lifestyles and reducing dependence on pain medications, particularly resonating with patients who had failed other treatments (painting a spinal cord stimulator operation as a solution to finally fix their pain).

However, emerging research has raised questions about the long-term effectiveness of all spinal cord stimulators, not just Nevro’s devices.

Studies published in medical journals suggest that while many patients experience initial pain relief, the benefits may diminish over time due to factors like tolerance, lead migration, or disease progression.

These findings have prompted more careful evaluation of when spinal cord stimulation is appropriate and highlighted the importance of realistic patient expectations about long-term outcomes.

If you or a loved one experienced device failure, lead migration, or serious complications after receiving a Nevro spinal cord stimulator, you may be eligible to seek compensation.

Contact TruLaw using the chat on this page to receive an instant case evaluation and determine whether you qualify to join others in filing a Nevro spinal cord stimulator lawsuit today.

Patients who received Nevro spinal cord stimulators have reported an alarming array of complications that far exceed the minor side effects disclosed in product materials, ranging from device malfunctions to life-altering neurological injuries.

While the company marketed its HF10 and HFX systems as safe alternatives to traditional pain management, real-world experiences reveal a troubling pattern of serious adverse events that were not adequately communicated to patients or physicians.

These complications have devastated lives, requiring multiple revision surgeries, causing permanent disabilities, and in some cases, leaving patients in worse condition than before implantation.

This detailed examination of reported complications provides compelling evidence for why affected patients are pursuing legal action against Nevro Corporation.

Device Malfunctions and Technical Failures

Device malfunctions represent one of the most frequently reported complications with Nevro spinal cord stimulators, affecting thousands of patients who expected long-term pain relief but instead experienced sudden loss of therapy, hardware failures, and the need for revision surgeries.

Lead migration, the movement of electrical leads from their intended position, stands out as a particularly prevalent issue that can render the device ineffective or cause unintended stimulation in wrong areas of the body.

While Nevro promoted its devices as having superior stability, real-world data paints a dramatically different picture.

Patients report experiencing these common device malfunctions:

• Lead migration affecting how spinal cord stimulators work, occurring in 30-40% of patients overall, with some studies suggesting even higher rates over time
• Complete device failure resulting in sudden loss of pain relief (when the electrical impulses no longer disrupt pain signals)
• Battery malfunctions including premature depletion despite promised 10-25 year lifespan
• Charging system failures preventing patients from maintaining therapy
• Loose connections causing intermittent stimulation or complete loss of function
• Lead fractures and breaks requiring surgical replacement
• Software glitches affecting programming and pain control

Recent medical literature reveals that lead migration remains the most common hardware-related complication across all spinal cord stimulator brands, with studies showing migration rates between 5.3% to 40% depending on the follow-up period and detection methods used.

The consequences of lead migration extend beyond simple loss of pain relief – displaced leads can stimulate unintended areas, causing worsening chronic pain, muscle contractions, or complete loss of therapeutic benefit.

For Nevro patients specifically, the high-frequency stimulation may mask early signs of migration until displacement causes severe pain and complete therapy failure.

Battery-related failures present another serious concern, particularly given Nevro’s marketing claims about extended battery life.

Patients report devices requiring increasingly frequent charging after spinal cord stimulator surgery, with some batteries failing completely within months or years rather than the advertised decades.

These failures often occur without warning, leaving patients who sought to alleviate chronic pain suddenly without relief and facing the prospect of another surgery to replace the implantable pulse generator.

The psychological impact of living with uncertainty about when the device might fail adds considerable stress to patients already dealing with chronic pain.

The ripple effects of device malfunctions extend throughout patients’ lives, causing physical pain and forcing them to cancel work, social activities, and medical appointments when devices unexpectedly stop functioning.

Many describe the devastating experience of planning their lives around charging schedules, only to discover their device won’t hold a charge or has failed completely.

For those who underwent initial surgery specifically to reduce medication dependence, device failure often means returning to opioids or other drugs they had hoped to avoid, creating additional health risks and complications.

Neurological and Physical Injuries

Patients who suffered severe injuries from Nevro spinal cord stimulators experienced neurological damage that resulted in permanent disability, fundamentally altering their lives in ways they never anticipated when consenting to the procedure.

These injuries range from nerve damage and spinal cord trauma to complete loss of bodily functions, as documented in the Ron Yusnukis lawsuit filed in New Mexico federal court.

The case highlights how a device intended to improve quality of life can instead cause catastrophic harm.

The most severe neurological and physical complications include:

• New or worsening spinal nerve root damage affecting sensation and motor function
• Paralysis or partial paralysis of limbs
• Loss of bowel and bladder control requiring lifelong management
• Cerebrospinal fluid (CSF) leaks causing severe headaches and neurological symptoms
• Spinal cord trauma from lead placement or migration
• Electric shock sensations described as lightning bolts through the body
• Burns at the implant site from device malfunction
• Chronic pain syndrome worse than the original condition

The Yusnukis case provides a harrowing example of these severe complications, with the plaintiff experiencing permanent loss of bowel control following his Nevro HF10 implant – a life-altering injury that requires constant management and has destroyed his quality of life, similar to patients who experienced nerve damage or loss of function due to spinal cord stimulator complications.

Medical literature confirms that spinal cord stimulators can cause serious neurological complications, though manufacturers often downplay these risks in their marketing materials.

The overall complication rate for spinal cord stimulation has been reported as high as 43%, with neurological injuries representing some of the most severe outcomes.

Cerebrospinal fluid leaks represent another serious complication that can occur during spinal surgery for implantation or as a result of lead migration.

These leaks cause debilitating headaches, nausea, and can lead to serious infections if not promptly treated.

Some patients describe positional headaches and neck pain so severe they cannot sit or stand upright, forcing them to remain horizontal for days or weeks while awaiting treatment.

The need for additional procedures to repair dural tears from spinal cord stimulator placement adds both risk and recovery time to what was marketed as a minimally invasive solution.

Electric shock sensations and burns represent a particularly frightening category of complications, with patients reporting sudden jolts of electricity that feel like being struck by lightning.

These shocks can occur without warning during normal activities, causing falls, accidents, and psychological trauma.

Some patients develop a fear of movement or specific positions that might trigger these painful shocks, leading to decreased mobility and social isolation.

Burns at implant sites have been reported when devices malfunction, causing thermal injury to surrounding tissue and requiring surgical intervention.

Patients experiencing neurological complications often face these life-altering challenges:

• Inability to work or maintain employment
• Loss of independence requiring full-time caregivers
• Severe depression and anxiety related to permanent disabilities
• Breakdown of family relationships due to caregiver stress
• Financial devastation from medical costs and lost income
• Social isolation due to embarrassment about loss of bodily functions

Infections and Surgical Complications

Infections represent one of the most common and serious complications following Nevro spinal cord stimulator implantation, with rates ranging from 3.4% to 10% according to recent studies.

These infections can occur at any point from the initial implantation through years after the procedure, requiring aggressive antibiotic treatment and often necessitating complete device removal.

For patients with diabetes or compromised immune systems, the risk increases substantially, yet many report inadequate screening or counseling about these elevated risks before surgery.

Healthcare providers commonly document these infection-related complications:

• Superficial wound infections at incision sites
• Deep infections involving the implanted hardware
• Epidural abscesses requiring emergency surgery
• Systemic infections (sepsis) that can be life-threatening
• Chronic infections resistant to antibiotic treatment
• Need for long-term IV antibiotics through PICC lines
• Multiple hospitalizations for infection management

The cascade of complications following infection often proves more devastating than the infection itself.

Device removal means loss of pain control, return to medications, and the difficult decision of whether to receive a new spinal cord stimulator after healing.

Studies show that infection is the most common reason for device explantation, with some patients enduring multiple surgeries to address recurring infections.

The financial burden of extended hospital stays, IV antibiotics, and lost wages compounds the physical suffering.

Revision surgeries to address lead migration, device migration, device failure, scar tissue formation, or infections carry their own substantial risks.

Multiple corrective surgeries increase the likelihood of complications including nerve damage, scarring, and infection.

Patients describe a vicious cycle where revision surgeries to fix one problem create new complications, leading to more procedures in an endless loop of surgical interventions.

Scar tissue from multiple surgeries can make future procedures more difficult and dangerous, while also contributing to chronic pain at surgical sites.

The mental health consequences of repeated surgeries manifest as:

• Severe anxiety about additional procedures
• Post-traumatic stress related to surgical experiences
• Depression from repeated failures to achieve pain relief
• Loss of trust in medical providers and device manufacturers
• Guilt about the burden placed on family caregivers
• Hopelessness about ever achieving normal function

For diabetic patients and those with compromised immune systems, the infection risk becomes even more pronounced.

Despite FDA approval for treating diabetic neuropathy, many patients report that the elevated infection risks for diabetics were not adequately explained during the consent process.

Some patients with a spinal cord stimulator developed severe infections that progressed rapidly due to their underlying condition, resulting in extended hospitalizations and permanent health consequences.

The intersection of diabetes and infection risk raises serious questions about whether Nevro adequately studied or disclosed these risks for vulnerable populations.

The cumulative impact of surgical complications extends beyond individual procedures to fundamentally alter patients’ relationship with healthcare.

Many describe developing medical trauma that makes them reluctant to seek necessary care for other conditions.

The financial strain of multiple surgeries, combined with lost income during extended recoveries, has pushed numerous families into bankruptcy.

These cascading consequences demonstrate how a device marketed as a solution for chronic pain can instead create an intricate web of new medical, financial, and psychological problems that persist long after device removal.

If you or a loved one suffered infections requiring device removal, neurological damage, or needed multiple revision surgeries after receiving a Nevro spinal cord stimulator, you may be eligible to seek compensation.

Contact TruLaw using the chat on this page to receive an instant case evaluation and determine whether you qualify to join others in filing a Nevro spinal cord stimulator lawsuit today.

Our Spinal Cord Stimulator attorney at TruLaw is dedicated to supporting clients through the process of filing a Spinal Cord Stimulator lawsuit.

With extensive experience in defective medical device lawsuit cases, Jessica Paluch-Hoerman and our partner law firms work with litigation leaders and medical experts to prove how defective spinal cord stimulator devices caused you harm.

TruLaw focuses on medical device lawsuits, securing compensation for medical expenses, pain and suffering, lost income, and other damages resulting from your spinal cord stimulator injury.

We understand the physical and emotional toll that Spinal Cord Stimulator complications have on your life and provide the personalized guidance you need when seeking justice.

Meet the Lead Spinal Cord Stimulator Attorney at TruLaw

Meet our lead Spinal Cord Stimulator attorney:

• Jessica Paluch-Hoerman: As founder and managing attorney of TruLaw, Jessica brings her experience in product liability and personal injury to her client-centered approach by prioritizing open communication and personalized attention with her clients. Through TruLaw and partner law firms, Jessica has helped collect over $3 billion on behalf of injured individuals across all 50 states through verdicts and negotiated settlements.

How much does hiring a Spinal Cord Stimulator lawyer from TruLaw cost?

At TruLaw, we believe financial concerns should never stand in the way of justice.

That’s why we operate on a contingency fee basis – with this approach, you only pay legal fees after you’ve been awarded compensation for your injuries.

If you or a loved one experienced complications from spinal cord stimulator implants, you may qualify to seek compensation.

Contact TruLaw using the chat on this page to receive an instant case evaluation and determine your eligibility to join others in filing a Spinal Cord Stimulator Lawsuit today.

Spinal cord stimulator lawsuits are being filed by individuals across the country who were injured by defective spinal cord stimulators or devices that malfunctioned after implantation.

TruLaw is currently accepting clients for the spinal stimulator lawsuit.

A few reasons to choose TruLaw for your spinal cord stimulator lawsuit include:

• If We Don’t Win, You Don’t Pay: The spinal cord stimulator lawyers at TruLaw and our partner firms operate on a contingency fee basis, meaning we only get paid if you win.
• Expertise: We have decades of experience handling medical device cases similar to the spinal cord stimulator lawsuit.
• Successful Track Record: TruLaw and our partner law firms have helped our clients recover billions of dollars in compensation through verdicts and negotiated settlements.

If you or a loved one suffered complications or injuries related to a defective or malfunctioning spinal cord stimulator, you may be eligible to seek compensation.

Contact TruLaw using the chat on this page to receive an instant case evaluation that can determine if you qualify for the spinal cord stimulator lawsuit today.