Patients who received Nevro’s Senza-line spinal cord stimulators have begun filing product liability lawsuits alleging the devices are defectively designed, were marketed with misleading claims, and left them with worsened chronic pain or serious complications rather than the relief they were promised. The Nevro spinal cord stimulator lawsuit filings started appearing in federal court in early 2026, and in June 2026 the U.S. Judicial Panel on Multidistrict Litigation declined to fold them into a broader industry-wide consolidation, leaving Nevro cases to proceed on a separate track from other manufacturers.
What Patients Are Alleging
Three lawsuits filed on March 23, 2026, in the U.S. District Court for the Northern District of California accuse Nevro of selling defectively designed stimulators that made patients’ pain worse. A recurring thread involves the mismatch between the temporary trial stimulator patients use before surgery and the permanent implant they receive afterward. Plaintiffs say the trial device eased their pain, the permanent implant did not, and no one warned them the two would perform differently.1Becker’s Spine. Nevro Faces Claims of Defective Spinal Cord Stimulators
At least one plaintiff alleges that a Nevro sales representative reprogrammed the implanted device without a physician present.1Becker’s Spine. Nevro Faces Claims of Defective Spinal Cord Stimulators The wider set of Nevro-specific claims reaches across the company’s product line, including the Senza, Senza II, Senza Omnia, HFX, and HFX iQ systems, and cites failures such as lead migration, device fracture, and battery malfunctions.2Wisner Baum. Spinal Cord Stimulator Lawsuit
Plaintiffs also raise the broader question of whether spinal cord stimulation works meaningfully better than placebo. Attorneys point to independent research suggesting that SCS therapy often performs no better than sham stimulation, which they argue undercuts the case for accepting the risks of an invasive implant at all.2Wisner Baum. Spinal Cord Stimulator Lawsuit
The FDA Supplement Pathway Argument
A central legal theory targets how Nevro has changed its devices since they first reached the market. The Senza system received full Premarket Approval from the FDA in May 2015 under PMA number P130022. Since then, Nevro has filed at least 65 supplements to that original approval, covering changes to design, components, specifications, and materials.3U.S. Food and Drug Administration. PMA P130022 – Senza Spinal Cord Stimulation System One supplement approved in October 2022 introduced the Senza HFX iQ system with a Bluetooth-enabled pulse generator and a patient smartphone application.4U.S. Food and Drug Administration. PMA P130022/S044 – Senza HFX iQ System
Plaintiffs argue that Nevro and other stimulator manufacturers used the supplement process to roll out substantially redesigned devices without the safety review a new PMA application would require, and that manufacturers failed to run new clinical trials for those post-approval design changes or to warn patients adequately about risks including nerve damage, infection, and paralysis.2Wisner Baum. Spinal Cord Stimulator Lawsuit
Reported Injuries and Complication Rates
The FDA’s MAUDE database contains numerous adverse event reports involving Nevro stimulators. A 2019 report described a patient with increasing pressure and sharp pains at the pulse generator implant site that persisted even after the device was turned off, with ongoing pain and swelling that interfered with physical therapy and daily life.5U.S. Food and Drug Administration. MAUDE Adverse Event Report 9818010 A 2017 report documented a patient who developed infection, necrotic tissue, and purulent discharge at the implant site about two weeks after surgery, requiring surgical removal of the device.6U.S. Food and Drug Administration. MAUDE Adverse Event Report 6852142 A 2025 report described a Nevro device that became infected and had to be explanted.7U.S. Food and Drug Administration. MAUDE Adverse Event Report 23110265
Category-wide research shows the scale. A systematic review covering more than 13,000 permanent SCS implantations found an aggregate explantation rate of 9.82%, with individual studies reporting rates as high as 38%. The most common reasons for removal were loss of pain relief (38.3% of reported reasons), lead failure or migration (15.2%), and infection (14.2%).8National Library of Medicine. Systematic Review of SCS Explantation Rates A European chart review of 955 SCS implants found that high-frequency rechargeable systems, the category that includes Nevro’s 10 kHz technology, had an explantation rate of 14.2% for inadequate pain relief, compared to 6.9% for conventional nonrechargeable devices.9Neuromodulation Journal. SCS Explantation Rates by Device Type
The FDA’s own summary of safety data for the Senza system catalogues potential adverse effects ranging from infection and lead migration to spinal cord compression, paralysis, and death. In a clinical study of 216 randomized subjects, 31 patients (14.4%) experienced 52 serious adverse events, including paraplegia, cardiac arrest, and sepsis. The FDA has also stated that the Senza device “has not been withdrawn from marketing for any reason related to its safety or effectiveness.”10U.S. Food and Drug Administration. Senza SCS System Summary of Safety and Effectiveness Data
Where the Cases Stand
Plaintiffs initially asked the U.S. Judicial Panel on Multidistrict Litigation to consolidate spinal cord stimulator cases from across the industry into a single MDL. On June 5, 2026, the Panel declined, ruling that an industry-wide MDL was not appropriate given the differences in each manufacturer’s regulatory history and device lines. Instead, the Panel created a narrower MDL limited to Boston Scientific spinal cord stimulator lawsuits, centralized in the Central District of California before Judge Josephine L. Staton.11U.S. Judicial Panel on Multidistrict Litigation. MDL-3181 Transfer Order
At the time of that ruling, seventeen cases naming Nevro and Globus Medical were pending. The Panel said actions against other manufacturers would be handled “in due course” through its conditional transfer order process if appropriate, but for now, Nevro cases are being pursued individually and separately from the Boston Scientific MDL.11U.S. Judicial Panel on Multidistrict Litigation. MDL-3181 Transfer Order
Who Is Responsible After the Globus Acquisition
On April 3, 2025, Globus Medical completed its acquisition of Nevro Corp. through a merger in which Nevro survived as a wholly owned subsidiary of Globus. Outstanding Nevro shares were cancelled and converted into the right to receive $5.85 per share, and Globus recorded a bargain purchase gain of approximately $110.6 million.12Globus Medical. Form 10-Q for the Period Ended June 30, 2025 Because Nevro continues to exist as a subsidiary rather than being dissolved, the corporate entity and its legal obligations remain intact within the Globus structure, which is why the pending suits name both companies.
Neither company has issued a specific public statement addressing the product liability lawsuits. Globus Medical’s SEC filings identify “the outcome of litigation” as a risk factor and note acquisition-related legal costs, but do not publicly break out the detailed litigation contingencies.12Globus Medical. Form 10-Q for the Period Ended June 30, 2025