Boston Scientific Spinal Cord Stimulator Problems Lawsuit

Boston Scientific has developed multiple surgically implanted spinal cord stimulator (SCS) models designed to manage chronic pain through electrical impulses delivered to the spinal cord.

While these devices were intended to improve quality of life for patients suffering from intractable pain, numerous reports have emerged indicating serious complications affecting thousands of patients across the United States.

Common Boston Scientific SCS Models and Their Intended Functions

Boston Scientific’s spinal cord stimulator portfolio encompasses several key models:

• WaveWriter Alpha System: FDA approved in December 2020, this system features FAST (Field-Activated Smart Technology) therapy capabilities and offers both 16-contact and 32-contact options. The device provides paresthesia-based and sub-perception therapy modes, allowing physicians to customize treatment approaches based on patient response.
• Spectra WaveWriter System: This earlier-generation device combines multiple therapy options in a single platform, enabling what Boston Scientific calls “Combination Therapy.” The system allows simultaneous delivery of different waveforms to target various pain patterns.
• Precision System: Originally approved by the FDA in April 2004 under PMA P030017, this system has undergone numerous modifications through supplemental approvals. Unlike newer models, many Precision systems lack full-body MRI compatibility, limiting diagnostic options for implanted patients.

All three systems share common components including an implantable pulse generator (IPG), lead wires placed near the spinal cord to treat chronic pain, and a programmer for adjusting stimulation parameters.

Boston Scientific markets these devices as rechargeable or non-rechargeable options, with battery life expectations ranging from 3-25 years depending on usage patterns and model specifications.

According to FDA documentation, over 50,000 patients have been implanted with various Boston Scientific SCS models, though exact distribution numbers for each system remain proprietary.

How Boston Scientific Spinal Cord Stimulators Work

Spinal cord stimulators function by interrupting pain signals before they reach the brain through carefully calibrated electrical pulses.

The implantable pulse generator, typically placed under the skin in the lower back or abdomen, sends controlled electrical currents through insulated lead wires positioned in the epidural space near specific spinal cord segments.

Traditional paresthesia-based therapy creates a tingling sensation that masks pain and may reduce reliance on pain medications, while newer sub-perception modes deliver stimulation below the sensory threshold.

The implantation process proceeds through three stages, allowing patients to experience the full effects of the therapy before permanent placement:

• Trial Period: Medicare and most insurers require a 3-7 day trial stimulation period before permanent implantation. The National Institute of Neurological Disorders and Stroke recognizes this trial phase as standard practice to determine patient responsiveness. Success is typically defined by the physician as achieving at least 50% pain reduction.
• Surgical Implantation: Following a successful trial, patients undergo surgery with a qualified surgeon to place the permanent system. The procedure involves threading leads through the epidural space under fluoroscopic guidance and creating a pocket for the pulse generator.
• Programming and Adjustment: Post-implant programming sessions allow physicians to optimize stimulation parameters including frequency, amplitude, and pulse width to achieve optimal pain relief while minimizing side effects.

Clinical studies involving patients implanted between 2010 and 2021 have reported trial-to-permanent conversion rates increasing from 63.4% to 73.3%, suggesting improved patient selection criteria.

However, long-term effectiveness remains variable, with studies indicating 50-70% of patients maintaining meaningful pain relief at one year post-implant.

The WaveWriter Alpha’s MR Conditional designation permits full-body 1.5T MRI scans and ct scans when specific safety protocols are followed, addressing diagnostic imaging limitations of earlier models.

FDA Regulatory History and Approval Process

The regulatory pathway for Boston Scientific’s spinal cord stimulators has become a focal point of recent litigation, with allegations that the company exploited loopholes to avoid rigorous safety testing.

The Precision System received initial approval through the FDA’s Premarket Approval (PMA) process in 2004, theoretically subjecting it to the highest level of regulatory scrutiny.

However, subsequent modifications have raised serious concerns about patient safety.

Recent lawsuits filed in 2025 allege that Boston Scientific circumvented proper regulatory channels through the following methods:

• Expedited PMA Supplements: Rather than filing new PMAs for substantial design changes, the company allegedly used incremental supplements to introduce major modifications without comprehensive safety reviews. Court documents indicate over 300 supplements have been filed for the Precision system alone.
• 180-Day Supplements: These expedited review pathways, intended for minor changes, were allegedly used for alterations affecting device safety and efficacy. The FDA’s PMA database shows numerous supplements approved through shortened review periods.
• Avoiding Clinical Trials: By characterizing changes as minor modifications, Boston Scientific allegedly avoided conducting new clinical trials that might have identified safety issues before widespread distribution.

The Dena Lawler case, filed in May 2025, represents the first lawsuit naming both Boston Scientific and the FDA as defendants, arguing that the regulatory agency violated federal law by failing in its duty to protect patients through approving these incremental changes without adequate review.

This unprecedented legal action highlights growing concerns that the PMA supplement process has been manipulated to fast-track device modifications at the expense of patient safety, potentially affecting tens of thousands of implant recipients nationwide.

If you or a loved one experienced device malfunctions, inadequate pain relief, or required revision surgery after receiving a Boston Scientific 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 Boston Scientific spinal cord stimulator lawsuit today.

The current litigation landscape surrounding Boston Scientific spinal cord stimulation reflects growing recognition of the harm these devices have caused patients nationwide.

Recent lawsuits reveal a pattern of corporate conduct prioritizing profits over patient safety, with allegations extending beyond simple product defects to systematic regulatory manipulation.

TruLaw partners with mass tort litigation leaders to provide clients with the legal resources and support necessary for a successful outcome in these medical device cases against corporate defendants with vast resources.

Current Lawsuit Allegations

Lawsuits against Boston Scientific for spinal cord stimulator injuries center on these primary allegations:

• Defective Design and Manufacturing: Plaintiffs allege Boston Scientific’s SCS devices contain inherent design flaws that make them unreasonably dangerous for their intended use. These defects include software vulnerabilities causing unexpected resets, hardware components prone to failure, and inadequate safety mechanisms to prevent device malfunctions during routine operations like charging or MRI procedures.
• Failure to Warn of Known Risks: Lawsuits document Boston Scientific’s failure to adequately warn physicians and patients about serious risks including device migration, electrical shocks, spinal compression from scar tissue, and the high rate of treatment failure. Internal documents revealed through litigation suggest the company possessed knowledge of these risks but failed to update product labeling or marketing materials.
• Regulatory Manipulation Through PMA Supplements: The Dena Lawler case, filed May 1, 2025, in the U.S. District Court for Central California, represents the first lawsuit naming both Boston Scientific and the FDA as defendants. Lawler alleges Boston Scientific “improperly used the premarket approval supplement pathway” to implement substantial device modifications without undergoing proper safety review, circumventing regulations designed to protect patients.
• Negligent Marketing and Misrepresentation: Plaintiffs claim Boston Scientific’s aggressive marketing campaigns overstated device benefits while minimizing risks. Sales representatives allegedly pressured physicians to implant devices in unsuitable candidates, promoted off-label uses, and provided inadequate training on proper patient selection and device programming.

The Lawler case exemplifies the severe consequences of these alleged failures.

After receiving a Spectra WaveWriter implant in 2020 for chronic pain management, Lawler experienced lead migration and malposition within one month, requiring revision surgery just three months after initial implantation.

She subsequently developed chest pain and cardiac arrhythmia, conditions her lawsuit directly attributes to the defective device and Boston Scientific’s failure to ensure its safety before market release.

Legal Theories and Claims

Plaintiffs pursue multiple legal theories to hold Boston Scientific accountable:

• Design Defect Claims: These claims assert that Boston Scientific’s SCS devices are inherently dangerous due to fundamental design flaws that could have been avoided through reasonable alternative designs. Expert testimony demonstrates safer design options existed at the time of manufacture, including better anchoring systems to prevent lead migration, more robust software architecture to prevent unexpected resets, and improved biocompatible materials to reduce tissue reactions.
• Manufacturing Defect Claims: Separate from design issues, manufacturing defect claims focus on devices that deviated from intended specifications during production. Quality control failures, contamination during assembly, and inadequate testing protocols allegedly allowed defective units to reach patients, causing preventable injuries.
• Breach of Express and Implied Warranties: Boston Scientific marketed its devices with specific promises about safety, efficacy, and MRI compatibility that proved false. Breach of warranty claims seek compensation for patients who relied on these representations when choosing to undergo implantation, only to discover the devices failed to perform as warranted.
• Punitive Damages for Willful Misconduct: Evidence suggesting Boston Scientific knowingly concealed safety risks or manipulated regulatory processes opens the door for punitive damages. Courts may award additional compensation beyond actual damages to punish corporate wrongdoing and deter similar conduct.

The strength of these legal theories lies in their complementary nature—plaintiffs need not prove all theories to recover compensation.

Success on any single claim can result in substantial awards covering medical expenses, lost wages, pain and suffering, and potentially punitive damages designed to hold Boston Scientific accountable for prioritizing profits over patient safety.

Please be advised that the settlement amounts mentioned above are general estimations and are not guaranteed.

These figures are based on historical settlements in similar medical device cases and opinions of legal experts familiar with spinal cord stimulator litigation.

Each case is unique, and settlement amounts depend on numerous factors including the severity of injuries, medical expenses incurred, impact on quality of life, and specific circumstances of device failure.

Contact TruLaw using the chat on this page to receive an instant case evaluation and discuss the specific factors that may affect your potential settlement.

Evidence Supporting Patient Claims

Plaintiffs build compelling cases against Boston Scientific by leveraging the following evidence:

• FDA Adverse Event Reports: The FDA’s MAUDE database contains thousands of adverse event reports specific to Boston Scientific spinal cord stimulators. These reports document device malfunctions, patient injuries, and deaths, providing pattern evidence of systematic problems rather than isolated incidents. Each report includes manufacturer responses, often revealing corporate knowledge of recurring issues.
• Medical Records and Surgical Documentation: Comprehensive medical records prove the causal link between device implantation and subsequent injuries. Operative reports detail device placement, revision surgeries document complications like lead migration or tissue damage, and diagnostic imaging reveals hardware failures invisible to external examination. Emergency department visits for electrical shocks or sudden loss of therapy provide contemporaneous documentation of device malfunctions.
• Expert Testimony on Design and Manufacturing: Biomedical engineers, neurosurgeons, and regulatory experts provide testimony explaining how Boston Scientific’s devices fall short of industry standards. These experts identify specific design flaws, propose safer alternatives available at the time of manufacture, and explain how proper testing would have identified problems before market release. Their testimony transforms technical issues into understandable evidence of corporate negligence.

Additional supporting evidence includes internal corporate documents obtained through discovery, comparative analysis with competitor devices showing superior safety profiles, and published medical literature documenting complications rates exceeding those disclosed by Boston Scientific.

This comprehensive evidence base enables experienced attorneys to build powerful cases demonstrating how Boston Scientific’s conduct directly caused patient injuries, justifying substantial compensation awards.

If you or a loved one experienced device failures, required revision surgeries, or suffered permanent injuries from a Boston Scientific 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 Boston Scientific spinal cord stimulator lawsuit today.

Boston Scientific spinal cord stimulator devices have been subject to multiple regulatory actions and safety communications that reveal systemic issues affecting patient safety.

Recent product advisories combined with broader FDA findings about spinal cord stimulator risks demonstrate a pattern of problems that extends beyond isolated incidents.

TruLaw closely monitors these developments to protect clients’ interests and ensure they receive appropriate compensation for device-related injuries through partnerships with experienced litigation leaders.

Recent Product Advisories and Recalls

Boston Scientific has issued several safety advisories for their SCS devices, most notably:

• Affected Models and Distribution: The recall specifically targeted models SC-1216 (16 IPG KIT) and SC-1232 (32 IPG KIT) with serial numbers ranging from 100188 to 759404. While Boston Scientific characterized the issue as causing “transient” symptoms, the FDA acknowledged that patients experienced enough distress to request surgical intervention for device replacement or revision.
• Software Update Response: Boston Scientific developed an in-field firmware update to eliminate the coincident routine device system check during charging. However, this required patients already suffering from the malfunction to undergo additional medical procedures and programming sessions. The company’s advisory instructed physicians to “review any patient reports of undesired sensations” and document firmware updates in medical records.
• Global Impact: The advisory affected patients across the United States and 34 other countries, demonstrating the widespread distribution of potentially defective devices. States with significant numbers of affected devices included California, Texas, Florida, New York, and Pennsylvania, among others throughout the nation.

The pattern of advisories reveals recurring themes: software design flaws, inadequate pre-market testing, and reactive rather than proactive safety measures.

Each advisory represents thousands of patients experiencing device malfunctions that Boston Scientific failed to prevent through proper design and testing protocols.

FDA’s Broader Concerns About SCS Safety

The FDA’s analysis of spinal cord stimulator safety has uncovered these troubling findings:

• Mortality and Adverse Events: FDA data from September 2020 documented 428 patient deaths linked to spinal cord stimulators between 2005 and 2020, with nearly one-third occurring within 30 days of implantation. The agency received 107,728 adverse event reports between 2016 and 2020 alone, indicating widespread safety concerns across all manufacturers.
• Inadequate Pain Relief: Of particular concern, 30,321 reports (28% of all adverse events) cited “inadequate pain relief” as the primary problem. This finding directly contradicts manufacturer claims about device efficacy and suggests many patients undergo invasive surgery without receiving promised benefits. The FDA noted this “highlights the need for patients to undergo and demonstrate an adequate trial” before permanent implantation.
• Public Citizen’s Regulatory Critique: In June 2020, Public Citizen published a comprehensive report calling the FDA’s oversight “dangerously lax.” The consumer advocacy group documented how manufacturers obtained approvals based on studies of other devices rather than prospective clinical trials, circumventing safety requirements designed to protect patients. Public Citizen demanded stricter regulatory oversight, including original PMA submissions for all new models.
• Trial Period Compliance Failures: Despite clear labeling requirements for trial stimulation periods before permanent implantation, FDA expressed concern about widespread non-compliance. All major manufacturers—including Boston Scientific—require successful trial periods demonstrating at least 50% pain reduction, yet adverse event data suggests many physicians skip or inadequately perform these screening procedures.

The FDA’s findings paint a troubling picture of an industry prioritizing rapid market entry over patient safety.

The combination of high mortality rates, inadequate pain relief, and regulatory workarounds has created a public health crisis affecting tens of thousands of patients who trusted these devices to improve their quality of life.

MRI Safety Issues and Restrictions

MRI compatibility issues with Boston Scientific spinal cord stimulators manifest in several ways:

• “MRI-Conditional” Limitations: While Boston Scientific markets newer devices as “MRI-conditional,” this designation comes with restrictions that patients often don’t fully understand. The WaveWriter Alpha system requires specific protocols including powering off stimulation, maintaining precise positioning, and limiting scan duration. Even with these precautions, risks remain substantial.
• Device Heating and Migration Risks: FDA warnings indicate that MRI exposure can cause device heating sufficient to cause tissue damage, lead migration requiring surgical correction, and permanent damage to stimulator electronics. Older Boston Scientific models like certain Precision systems remain completely MRI-unsafe, preventing patients from receiving diagnostic imaging for other medical conditions.
• Real-World Compliance Challenges: Research published in medical journals documents cases where high impedance prevented devices from entering MRI-conditional modes, potentially exposing patients to serious harm if scans proceeded. The complications of MRI safety protocols, combined with varying restrictions across different models, creates dangerous confusion for both patients and healthcare providers.

The MRI safety issues exemplify broader problems with Boston Scientific’s approach to device design and patient safety.

By rushing “MRI-conditional” technology to market without fully addressing technical limitations, the company has created situations where patients must choose between necessary diagnostic imaging and maintaining their pain management therapy.

For many patients, the promise of MRI compatibility proved illusory when faced with actual clinical needs.

If you or a loved one suffered complications from MRI procedures, device malfunctions, or were unable to receive necessary medical imaging due to your Boston Scientific 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 Boston Scientific spinal cord stimulator lawsuit today.

Boston Scientific spinal cord stimulators have been associated with a comprehensive range of complications and malfunctions that have prompted FDA warnings, product advisories, and multiple lawsuits across the country.

FDA data reveals that between 2016 and 2020 alone, the agency received 107,728 adverse event reports related to all spinal cord stimulators, including 428 patient deaths.

TruLaw is actively investigating these claims to help affected patients understand their legal options and pursue compensation for device-related injuries.

Device Malfunctions and Technical Failures

Boston Scientific SCS devices have experienced widespread technical failures, specifically:

• Failure to Exit MRI Mode: In July 2024, Boston Scientific issued an urgent medical device advisory affecting WaveWriter Alpha rechargeable models. The advisory revealed that devices could fail to resume therapy after MRI scans, leaving patients without pain relief. The FDA classified this as a Class 2 recall.
• Charging System Failures: Rechargeable models have experienced complete charging failures, rendering devices non-functional. Patients report batteries that won’t hold charge, charging units that overheat, and complete system shutdowns requiring surgical replacement.
• Software Glitches and Programming Errors: Devices have spontaneously reset to factory settings, lost programmed parameters, or delivered incorrect stimulation patterns. Some patients experienced sudden, unexplained changes in stimulation intensity without adjusting their controllers.
• Lead Disconnection and Hardware Failures: Internal component failures have caused complete loss of stimulation, intermittent therapy delivery, and system error messages that cannot be resolved through standard troubleshooting procedures.

Boston Scientific acknowledged that the device behavior “may result in a delay or interruption in therapy” and developed a software update to address the issue.

However, thousands of patients had already been implanted with the affected devices, many experiencing prolonged periods without adequate pain management while awaiting repairs or replacements.

Physical Complications and Injuries

Patients have reported severe physical complications from Boston Scientific spinal cord stimulators, such as:

• Electrical Shocks and Burns: Multiple adverse event reports document patients experiencing painful electrical jolts, burning sensations at the implant site, and electrical shocks traveling through the body. These events have occurred during normal device operation, not just during malfunctions.
• Nerve Damage and Tissue Injury: Improper lead placement or migration has resulted in documented cases of permanent nerve damage, with patients experiencing new onset numbness, weakness, head pain, or paralysis in extremities. Spinal cord injury following implantation, while rare, carries devastating consequences.
• Infection and Device Rejection: Post-surgical infections at implant sites have necessitated complete system removal, extended antibiotic treatment, and prolonged recovery periods. Some patients developed chronic infections resistant to standard treatment protocols.
• Spinal Compression from Scar Tissue: Perhaps most concerning are reports of excessive scar tissue formation around epidural leads, creating masses that compress the spinal cord. This complication can develop months or years after implantation, causing progressive neurological symptoms including difficulty walking, loss of bladder control, and permanent paralysis if not addressed immediately.

Research published in medical journals confirms these complications align with broader spinal cord stimulator adverse event patterns.

The variable onset time (from immediate post-surgical complications to problems emerging years later) makes it important for patients to maintain vigilance and seek immediate medical attention for new or worsening symptoms.

Many patients report undergoing multiple revision surgeries to address these complications, each carrying additional surgical risks and recovery burdens.

Inadequate Pain Relief and Treatment Failure

Boston Scientific SCS devices have demonstrated these concerning patterns of treatment failure:

• High Failure Rates: Approximately 30% of patients report receiving little to no pain improvement despite successful implantation and proper device function. This failure rate exceeds what patients are typically told during the consultation process.
• Worsening of Existing Pain: Some patients experience paradoxical effects where the stimulator actually increases their pain levels or creates new pain patterns. This includes development of allodynia (pain from normally non-painful stimuli) and hyperalgesia (increased sensitivity to painful stimuli).
• Loss of Efficacy Over Time: Many patients who initially experience relief find the therapy becomes less effective within months, requiring constant reprogramming, increased stimulation intensity, or eventual device removal when adjustments no longer provide benefit.
• Failure of Advanced Therapy Modes: Despite marketing claims about innovative sub-perception and FAST therapy capabilities, clinical reality shows these modes fail to provide adequate relief for many patients, particularly those with pain syndromes.

The psychological impact of treatment failure cannot be overstated.

Patients undergo invasive surgery with high hopes for pain relief, only to discover the device provides minimal benefit or makes their condition worse.

According to CDC data, chronic pain affects approximately 50 million adults in the United States, and the FTC has taken enforcement actions against companies making unsubstantiated pain relief claims.

Failed treatments often leave patients with limited options, as the presence of the device or scar tissue from its removal can complicate future pain management approaches.

If you or a loved one experienced inadequate pain relief, device malfunctions, or physical injuries after receiving a Boston Scientific spinal cord stimulator implant, 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 Boston Scientific 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 product liability 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 securing compensation for medical expenses, pain and suffering, lost income, inability to perform normal activities, 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 legal services and 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 or malfunctioning spinal cord stimulators.

TruLaw is currently accepting clients for the spinal cord 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 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.