Boston Scientific Spinal Cord Stimulator Lawsuit

The Spinal Cord Stimulator Lawsuit Is An Active Lawsuit

See If You Qualify

Spinal cord stimulator patients are suing Boston Scientific because they believe they should have been warned about complications they experienced. Complications discussed in lawsuits include lead migration, shocking sensations, burns, nerve damage, new or worsening pain, and surgery to correct or remove the device. Spinal cord stimulator (SCS) models named in lawsuits against Boston Scientific include WaveWriter Alpha, WaveWriter Alpha Prime, Precision Spectra, Precision Montage MRI, and Spectra WaveWriter.

Some Boston Scientific SCS lawsuits have been centralized into a multidistrict litigation (MDL) called Boston Scientific Corporation Spinal Cord Stimulator Products Liability Litigation (MDL 3181). Individual and group claims continue to be filed in state and federal courts. More lawsuits may be transferred into the MDL if they meet the eligibility criteria.

On this page, we discuss existing lawsuits against Boston Scientific, allegations in those lawsuits, which devices and injuries may qualify someone for a new lawsuit, the federal group litigation, injury reports submitted to the FDA about Boston Scientific’s SCS devices, and how our lawyers file cases and represent plaintiffs.

About the Boston Scientific Spinal Cord Stimulator Lawsuit

What Is the Boston Scientific Spinal Cord Stimulator Lawsuit?

The Boston Scientific spinal cord stimulator lawsuit includes allegations that the company’s SCS devices were defective, malfunctioned, or failed to give people the pain relief they expected. These lawsuits are personal injury claims filed in civil courts. The goal of these lawsuits is to compensate a plaintiff for their injuries and hold the company accountable for alleged wrongs.

What Are the Reasons Behind the Boston Scientific Spinal Cord Stimulator Lawsuits?

People are filing SCS lawsuits against Boston Scientific because they believe that the company did not test for, track, or warn about the risks as it should have. People also claim the company did not design SCS to be safe and effective for patients.

Here are some of the allegations in existing lawsuits against Boston Scientific because of its spinal cord stimulators:

• Design defects
• Manufacturing defects
• Failure to warn about the risks
• Negligence
• Misrepresentation about the safety, FDA approval, and efficacy of SCS
• Breach of warranty
• Failure to disclose adverse events reported by (or about) SCS patients

Boston Scientific Lawsuits and Allegations of PMA Misuse

Legal complaints also accuse Boston Scientific of improperly using FDA supplemental approvals to its original premarket authorization (PMA). On April 27, 2004, Boston Scientific received a PMA for its Precision Spinal Cord Stimulator (SCS) System (PMA P030017). Since that initial PMA was granted by the FDA, Boston Scientific has submitted supplements to the Precision PMA (i.e., device modifications) a total of 395 times.

Many plaintiffs argue that the resulting devices are different enough from the original to warrant a fresh approval from the FDA. Essentially, some plaintiffs say that Boston Scientific has used PMA supplements to put new, unapproved SCS on the market. Boston Scientific asserts it has followed the FDA approval process and denies these allegations.

Which Boston Scientific Spinal Cord Stimulator Devices Are Mentioned in Lawsuits?

All of Boston Scientific’s current spinal cord stimulators are named in lawsuits by people alleging injuries. Types of SCS that are named in the lawsuits include:

• WaveWriter
• Spectra WaveWriter
• Precision Spectra

Reported Issues With WaveWriter Alpha and WaveWriter Alpha Prime

Boston Scientific’s WaveWriter Alpha and WaveWriter Alpha Prime series have been named in several lawsuits, company notices, and FDA adverse event reports. For example, a patient who filed a lawsuit described feeling “sharp, shooting sensations from his hip” and a decrease in pain relief after having the WaveWriter Alpha system implanted. According to this complaint, Boston Scientific representatives reprogrammed the device multiple times, which did not help, and the patient had the device removed.

In 2024, Boston Scientific sent out a notice to warn about potential problems with the WaveWriter Alpha IPG system after charging.

Additionally, here are some of the WaveWriter Alpha injury reports submitted to the FDA’s MAUDE database:

• A patient describing device repositioning, resulting in a revision surgery.
• A patient describing inadequate pain relief and shocks.
• A patient experiencing severe shooting pain, and weakness.

Many patients who have experienced issues with the WaveWriter Alpha series of SCS have had the device removed because of complications or inadequate pain relief.

Reported Issues With Spectra WaveWriter

Several problems have also been reported about Boston Scientific’s Spectra WaveWriter models. For example, a woman filed a lawsuit after her Spectra WaveWriter SCS allegedly made her pain worse and caused her to experience new pain within a month after the first procedure. Her legal complaint also claims the leads of the SCS moved out of place and were not positioned correctly. According to her lawsuit, she had to have revision surgery within 3 months after having the device implanted.

Additionally, here are some of the Spectra WaveWriter injury reports submitted to the FDA’s MAUDE database:

• One patient had an SCS removed because it could not connect to the clinician programmer and had to be charged frequently .
• Another patient allegedly had their device taken out because of inadequate pain relief, even after the device was optimized several times.
• Another patient experienced poor pain relief and charging issues with their Spectra WaveWriter, eventually having the device removed.
• The implantable pulse generator (IPG) was replaced on another patient’s Spectra WaveWriter spinal cord stimulator because of charging difficulties.

Reported Issues With Precision Spectra and Other Precision Systems

Patients have also reported problems with Boston Scientific’s Precision spinal cord stimulator systems. For example, one patient filed a lawsuit after his Precision Montage system had to be reprogrammed about 10 times due to “unsatisfactory pain relief and severe pain, electric shocking sensations, and left lower extremity pain.” That patient also said he had surgery to move the battery back to a different position because of site-related pain, which did not provide symptom relief. Later, the patient had the SCS system removed.

Additionally, here are some of the Precision injury reports submitted to the FDA’s MAUDE database:

• A patient had the implantable pulse generator removed due to charging problems and lead migration.
• A patient had the leads replaced after the device would start or stop stimulation on its own, even after reprogramming, and the patient experienced “powerful electrical shocks.”
• A patient had difficulty charging their device and had to have it replaced.
• A patient experienced inadequate pain relief and charging challenges that required surgery to replace the device.

Recalls & Safety Notices Involving Boston Scientific SCS Devices and Components

Although SCS devices made by Boston Scientific have not been recalled, many of the components of these devices have been recalled. Since April 2010, SCS components made by Boston Scientific have been the subject of 10 FDA Class II medical device recalls .

A Class II recall is defined by the FDA as “a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”

The following components of SCS devices made by Boston Scientific have been recalled since 2010:

• Boston Scientific Model SC-4318, Clik X Anchor: 06/11/2026
• WAVEWRITER ALPHA: Model: SC-1216, 16 IPG KIT 08/14/2024
• ArtisanTM 70 cm 2 x 8 Surgical Lead Kit: 05/26/2020
• Fifty-five (55) cm 8 Contact Extension Kit: 05/26/2020
• Precision TM M8 Adapter, 15 cm: 05/26/2020
• The LinearTM 3-4 70 cm 8 Contact Lead Kit: 05/26/2020
• LinearTM 3-4 50 cm 8 Contact Lead Kit: 05/26/2020
• Thirty-five (35) cm 8 Contact Extension Kit: 05/26/2020
• OMG (Observational Mechanical Gateway) Connector: 04/19/2012
• Bionic NAVIGATOR Clinician Programmer: 04/16/2010

About the 2024 Boston Scientific WaveWriter Alpha Urgent Advisory

In July 2024, Boston Scientific sent out an urgent advisory about ongoing problems with its WaveWriter Alpha 16 and 32 IPG Kit models. According to the notice, some patients experienced charging and software-design issues that caused their implantable pulse generators to reset, turn stimulation on and off, and result in other unwanted complications. Boston Scientific said part of the reason these problems occurred was that the device would detect noise or interference in the charging area, triggering a device reset. The company said it issued a software update that it believed would correct this issue.

Is There a Boston Scientific Spinal Cord Stimulator MDL?

On June 5, 2026, the Judicial Panel on Multidistrict Litigation approved a request to create an MDL for spinal cord stimulator claims against Boston Scientific. The coordinated federal MDL is MDL No. 3181 and is called In re Boston Scientific Corporation Spinal Cord Stimulator Products Liability Litigation.

The Boston Scientific SCS MDL is consolidated in the Central District of California before the Honorable Josephine L. Staton. The MDL format allows the parties involved in the MDL to share resources and streamline parts of the legal process, such as fact-gathering, interviewing experts, preparing for trial, and filing pretrial motions.

Boston Scientific Spinal Cord Stimulator MDL Quick Facts

Updates on MDL 3181: Boston Scientific Corporation Spinal Cord Stimulator Products Liability Litigation

July 1, 2026: There are a total of 24 pending claims in the Boston Scientific MDL.

June 5, 2026: Judicial Panel on Multidistrict Litigation (JPML) centralizes SCS lawsuits against Boston Scientific, creating a multidistrict litigation (MDL)

May 28, 2026: JPML holds a conference during which it reviews a motion to consolidate SCS lawsuits filed against Boston Scientific and other defendants.

April 16, 2026: JPML says it will hear the request to have an MDL created for patients alleging injuries from SCS devices made by multiple companies, including Boston Scientific. The hearing will be held on May 28, 2026.

February 20, 2026: Attorneys representing 15 plaintiffs submit a motion to the JPML asking for centralization of SCS lawsuits into an MDL.

Possible Benefits to Patients Who Join the Boston Scientific SCS MDL

An MDL is a type of centralized litigation that allows some phases of the lawsuit to be performed for all plaintiffs. The reason MDLs are created is to reduce the burdens on plaintiffs, defendants, and the courts, while making for more consistent rulings for all parties.

In an MDL format, the people who filed the lawsuits work together to streamline parts of their lawsuits, such as requesting information, interviewing experts, and preparing for trial. However, each person can still have their own trial and enter a settlement for their individual losses.

Here are some of the benefits to SCS patients who join the MDL as plaintiffs:

• Plaintiffs do not need to obtain internal records from Boston Scientific. Discovery (the sharing of information between parties) is conducted as a group.
• Plaintiffs do not need to find their own experts. Experts (like scientists and physicians) who offer reports and testimony do so for all plaintiffs in the MDL.
• Each plaintiff’s case is evaluated on its own merits, meaning each person’s injuries and losses are what determine the amount of a potential settlement.

Filing an individual lawsuit against a large medical device manufacturer, like Boston Scientific, takes a lot of time, resources, and energy. Joining an MDL takes many of the most burdensome parts of a lawsuit off the plaintiff.

Is the Boston Scientific Spinal Cord Stimulator Lawsuit a Class Action?

At this time, most of the Boston Scientific SCS claims are being filed individually or by small groups of plaintiffs. However, a dedicated MDL was created where individual or group Boston Scientific SCS lawsuits can be filed or transferred into. An MDL is different from a class action lawsuit.

In a class action, all of the people in the class action merge their claims into one case against the same defendant. Their cases do not have individual trials, and any settlement reached applies to every claim. Payouts in class actions tend to be much smaller and less personalized than in MDLs or individual cases.

What Are the Main Legal Claims Against Boston Scientific?

Some of the main legal claims being brought against Boston Scientific for its SCS include:

• Failure to warn about risks
• Design or manufacturing defects
• Negligence
• Misrepresentation
• Misuse of the FDA’s device PMA supplement process (i.e., making major changes and modifications to an approved device)

Failure to Warn

Some lawsuits accuse Boston Scientific of failing to warn patients and providers about the risks associated with its SCS devices. Some of the complications that patients believe they should have been warned about include electrical shocks, lead migration, device resets, inadequate pain relief, and the need to have repeat surgeries to fix or replace the device.

Design or Manufacturing Defect

Lawsuits claim that Boston Scientific’s SCS devices are defectively designed. These legal complaints allege that the company’s SCSs do not provide the level of pain relief that patients were promised and that their design makes them more likely to malfunction.

Negligence and Misrepresentation

Patients who have filed lawsuits have also accused Boston Scientific and its representatives of overstating the possible benefits of the permanent SCS implants compared to the external trial version. They also claim Boston Scientific and its representatives downplayed or failed to mention known problems and reported adverse events associated with the SCSs.

Claims Involving FDA Approval and PMA Supplements

Some lawsuits claim that the FDA and Boston Scientific mishandled how SCSs were approved and modified. For instance, some claim that Boston Scientific supported its application by using safety data for SCSs that were made by other companies. Some claim that Boston Scientific should have used safety data for its own device when it asked for FDA approval. People have also claimed that Boston Scientific gained FDA approval for new SCS models by using the PMA supplemental process to modify the original FDA-approved design. People who have made this claim believe the company should have submitted a new application.

Why Is the FDA Named in Some Boston Scientific Spinal Cord Stimulator Lawsuits?

The FDA is named in some of the Boston Scientific SCS lawsuits because some claim that the agency may have allowed Boston Scientific to use the PMA supplement process instead of requiring Boston Scientific to submit a new application. Some lawsuits have also alleged that the FDA should not have approved Boston Scientific’s first SCS design by relying on clinical data for other FDA-approved SCSs.

Some lawsuits also allege that the FDA let Boston Scientific submit significant changes to its originally approved design, which Boston Scientific then used to make new models of SCSs. Some lawsuits allege that the FDA should have required Boston Scientific to submit a new application and conduct updated safety tests to show that its SCS devices were safe and effective.

What Evidence May Matter in a Boston Scientific Spinal Cord Stimulator Lawsuit?

Some evidence that may help support a spinal cord stimulator lawsuit against Boston Scientific includes the following:

• Medical device ID card (also called an implant card)
• The device model and serial number
• UDI (Unique Device Identifier) information
• The date that you had the implant done
• Records from the external SCS trial
• Medical reports and surgical notes from when you had the implant done
• Medical records of your revision surgery to correct, replace, or remove the SCS
• Medical documentation about complications you experienced after the implant
• Imagery or other medical tests that show lead migration (if applicable)
• Programming logs
• Charging history
• Reports about shocks, burns, resets, or loss of stimulation
• Records of communications with Boston Scientific or its representatives
• Recall or advisory notes (if applicable)
• Adverse event reports submitted to the FDA by you or someone on your behalf (if applicable)
• Photos of complications (e.g., pictures of device-related swelling, burns, lead migration, or infections)
• Pain journal or timeline of symptoms before and after the implant

Your attorney can help you identify and gather information to help support your SCS lawsuit against Boston Scientific. You may not need all of this information to file a lawsuit. It is a good idea to save chargers, remotes, implant cards, and other records or device components, as they could help strengthen your case against Boston Scientific.

Examples of Lawsuits Filed Against Boston Scientific for Alleged SCS Injuries

Several SCS have been filed against Boston Scientific. At least 10 SCS lawsuits against Boston Scientific were consolidated into the new MDL on June 5, 2026. Some of the lawsuits that were transferred into the MDL are as follows:

In the initial MDL order, the panel said at least 50 other SCS lawsuits were pending in state and federal courts, though not all of those were against Boston Scientific or part of the initial request to be included in the MDL. Some lawsuits that were part of the MDL at first may be transferred out, dismissed, or end in a settlement or verdict. More lawsuits are expected to be filed in federal and state courts as more SCS patients come forward about their experiences.

Have There Been Any Boston Scientific Spinal Cord Stimulator Settlements?

The Boston Scientific SCS lawsuits are still in their early stages, so there have not been any global settlements yet. Instead, any past settlements have been handled on an individual basis and may not have been made public. However, the Boston Scientific SCS lawsuits are progressing, and individual and group settlements may be reached in the future. Compensation that someone might receive in an SCS settlement includes money for medical bills, lost wages, pain and suffering, and loss of companionship of a spouse or loved one (i.e., loss of consortium).

What Could Happen Next in the Boston Scientific Spinal Cord Stimulator Litigation?

The Judicial Panel on Multidistrict Litigation has approved an MDL for SCS lawsuits against Boston Scientific. Typically, here are some of the next steps after an MDL is formed:

• Attorneys may be appointed to leadership positions to help manage the plaintiff and defense sides of the MDL.
• A master complaint is created and updated as needed.
• The MDL judge approves short-form complaints.
• Pretrial motions are filed (including motions to dismiss).
• The discovery (fact-gathering) schedule is planned out.
• Science Day is scheduled (i.e., the day where the judge hears about existing science about SCS devices, specifically those made by Boston Scientific).
• More lawsuits are filed or transferred into the MDL.
• Patients continue to report complications to their doctors and the FDA.
• Bellwether (test) trials are planned.
• Experts are interviewed.
• Settlements are discussed.

The Boston Scientific SCS MDL may involve similar steps going forward.

Who May Qualify for a Boston Scientific Spinal Cord Stimulator Lawsuit?

King Law’s eligibility criteria for Boston Scientific SCS include the following:

• The patient was implanted with an SCS made by Boston Scientific.
• The person experienced specific complications that they allege they were not properly warned about.

Some of the SCS complications that our firm is investigating include:

• Lead migration or getting out of position
• Electrical shocks or burning
• Device resetting
• Inadequate pain relief
• Nerve damage
• New or worsening pain
• Inconsistent stimulation
• Loss of bladder or bowel control
• Charging problems

Our firm may take someone’s SCS case even if they experienced complications that are not included on this list. Our firm is also accepting SCS claims involving devices made by other companies, including Abbott Laboratories.

What Injuries Are Named in Boston Scientific Spinal Cord Stimulator Lawsuits?

Some of the SCS injuries named in the lawsuits and FDA adverse event reports include the following:

• Electrical shocks or jolting sensations
• Burning near the implant or leads
• Lead migration
• Loss of pain relief
• Overstimulation or under-stimulation
• Battery pain or implantable pulse generator problems
• Device resetting during charging
• Generator flipping or pocket complications (check on this)
• Infection
• Nerve damage
• Worsening pain
• Repeated need to reprogram the device
• Surgery to revise (e.g., to fix or remove) the SCS
• Other permanent or long-term complications (like paralysis, lack of feeling in limbs, or inability to control bladder or bowels)

Some SCS patients say they were not properly warned about these possible side effects.

Is There a Deadline to File a Boston Scientific Spinal Cord Stimulator Lawsuit?

Someone needs to file their SCS lawsuit before the deadline (called a statute of limitations) expires. Every state has rules about when product liability, personal injury, and wrongful death lawsuits must be filed. Talking to a seasoned attorney early on can help patients understand when their filing deadline is and what they need to do to meet it.

How Can I File a Boston Scientific Spinal Cord Stimulator Lawsuit?

Filing a spinal cord stimulator lawsuit against Boston Scientific involves following the legal process, which includes:

• Contact one of our spinal cord stimulator attorneys and schedule a free consultation and determine potential eligibility.
• Work with your lawyer to gather medical records to support your claim against Boston Scientific.
• Your attorney determines what type of device you had implanted.
• Your attorney develops a timeline of the complications you experienced and when they occurred.
• Your lawyer files a legal complaint against Boston Scientific.
• Your attorney prepares for trial or tries to negotiate a fair settlement.

King Law has experience fighting for people who have been harmed by SCSs and other medical devices.

King Law Is Actively Reviewing Boston Scientific Spinal Cord Stimulator Claims

King Law is actively investigating claims from people who had a Boston Scientific SCS implanted and experienced complications and representing clients in their lawsuits. Some of the models that we are reviewing include WaveWriter Alpha, WaveWriter Alpha Prime, Spectra WaveWriter, Precision Spectra, and Precision Montage. We are prepared to help clients request compensation if they suffered from unexpected electrical shocks, burns, lead migration, infection, inadequate pain relief, nerve damage, revision surgery, and other complications.

Contact King Law for a Free Boston Scientific Spinal Cord Stimulator Lawsuit Review

Contact King Law today by calling (585) 496-2648 or filling out an online contact form if you were harmed by a Boston Scientific spinal cord stimulator. Our intake specialists are ready to take your call and help you schedule a free consultation with a qualified attorney on our team. We are actively engaging with and representing clients in spinal cord stimulator injury lawsuits.

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