Medtronic is one of the leading spinal cord stimulation manufacturers worldwide. Recently, Medtronic has come under scrutiny, as its devices have been the subject of FDA recalls, personal injury and product liability lawsuits, and allegations that they did not undergo proper clinical testing.
Wisner Baum continues to investigate spinal cord stimulator lawsuits, including those against Medtronic. Patients who have experienced harm after having a Medtronic spinal cord stimulator implanted are encouraged to contact the firm at (310) 207-3233 for a free case evaluation.
June 2026: On June 5, 2026, the U.S. Judicial Panel on Multidistrict Litigation (JPML) declined to create an industrywide spinal cord stimulator MDL. The panel centralized only the lawsuits against Boston Scientific (In re: Boston Scientific Corp. Spinal Cord Stimulator Products Liability Litigation, MDL No. 3181) before U.S. District Judge Josephine L. Staton in the Central District of California.
According to the panel, the claims against the different manufacturers, including Medtronic, involve different device designs, separate regulatory histories, and manufacturer-specific conduct, with no allegation that the companies acted together. As a result, Medtronic SCS lawsuits continue to proceed as individual cases rather than in a consolidated federal MDL. However, the panel left open the possibility for additional manufacturer specific MDLs to be formed, and so a Medtronic specific MDL may be formed in the future.
May 2026: The JPML heard oral argument on a motion to centralize spinal cord stimulator lawsuits filed across several federal courts. Some plaintiffs asked the panel to create a single industrywide MDL that would have included Medtronic alongside other manufacturers, while the manufacturers opposed consolidation, arguing that the cases involve different devices and different alleged defects.
April 2026: Additional Medtronic SCS complaints continued to be filed in federal court. One newly filed lawsuit alleged that a Medtronic Intellis spinal cord stimulator caused worsening pain and failed to provide effective relief, claiming the device was defectively designed and inadequately tested before implantation.
March 2026: Lawsuits allege that Medtronic made significant changes to its SCS devices after the FDA granted Premarket Approval (PMA), without seeking new PMA approval for those changes.
Instead, the company filed PMA supplements, which do not require the same rigorous approval process. It is alleged that these changes may have caused harm to patients and did not provide patients or providers with adequate information about the potential harm associated with using the devices.
May 2025: SCS manufacturers, including Medtronic, continue to face scrutiny as patients report serious complications related to the devices. According to legal documents, the devices may have caused harm such as worsening pain, erratic shocks, and other harm. Individuals who have suffered harm are encouraged to seek legal counsel.
April 2025: A publicly filed lawsuit by a Kentucky woman alleges her Medtronic SCS device contained significant defects which resulted in serious harm. The case, Yates v. Medtronic (D. Minn., April 2025), is one of several that have been filed against the company with similar allegations.
August 2024: Australia’s Therapeutic Goods Administration cancelled a number of spinal cord stimulators from its register, including Medtronic devices, following a post-market review that raised questions about whether the devices’ benefits outweigh their risks. The TGA noted that the cancelled devices were not recalled and did not need to be removed from patients who already had them implanted.
April 2024: On April 26, 2024, Medtronic announced that it had received FDA approval for its Inceptiv closed-loop spinal cord stimulator (SCS). Used to treat chronic pain and it is the company’s first SCS device to offer a closed-loop feature. According to marketing materials, the technology can detect biological signals and adjust stimulation levels in real time.
Medtronic was founded in 1949 and gained notoriety in 1957 for creating the first battery-operated pacemaker. Within two decades, the company had moved into neurostimulation devices and received FDA approval for the first fully implantable spinal cord stimulator (SCS), the Itrel, on November 30, 1984, under PMA P840001. Since then, Medtronic’s SCS product line has undergone several generations, maintaining its dominance in the industry.
Two popular generations of Medtronic SCS platforms are the Intellis and Vanta systems. Both systems are part of the company’s non-rechargeable SCS product lines with AdaptiveStim technology. Both have also been subject to Class II FDA recalls. The Intellis device has also been named in several publicly filed lawsuits in which patients allege the device was defective or dangerous.
Information about the Intellis system:
Information about the Vanta system:
Medtronic’s newest generation of SCS devices is the Inceptiv closed-loop rechargeable spinal cord stimulator (SCS), which received FDA approval in April 2024. The device is the company’s first stimulator to feature a closed-loop system that senses biological signals. It is also noteworthy because it reportedly adjusts stimulation in real time and is marketed as the world’s smallest and thinnest fully implantable SCS device. Because it has only recently entered the market, long-term safety data on the Inceptive device remain limited.
Older Medtronic SCS models, referred to as legacy devices, have also been subject to FDA recalls and adverse event reports. These devices include the Restore, RestoreUltra, RestoreSensor, Synergy, and original Itrel systems. Recalls occurred for a variety of reasons, including that certain devices were prone to overstimulation or stimulation in the wrong area. Patients with older generations of Medtronic SCS devices may still be entitled to take legal action if they experienced adverse effects related to their implant.
Several Medtronic SCS devices have been the subject of multiple FDA recalls, including Class 2 recalls, which are issued when the use or exposure to the product may cause temporary or reversible health consequences.
On March 28, 2024, a class 2 recall was initiated for the Intellis Implantable Neurostimulator with AdaptiveStim technology. According to the FDA, the recall was the result of a programmability issue. The recall was posted by the FDA on April 26, 2024.
Prior to issues with the Intellis, 3,791 Vanta with AdaptiveStim Implantable Neurostimulators were recalled. The recall was the result of a device design in which a cardioversion procedure could damage the electronics and render the device “unresponsive or non-functional.” The Class 2 recall was issued on June 6, 2023.
Older Medtronic spinal cord stimulator devices, including the RestoreUltra, RestoreSensor, Specify leads, and Medtronic Lead Kits, have also been the subject of Class 2 and Class 3 recalls. The history of recalls on these devices may raise safety concerns. Patients are encouraged to discuss the benefits and risks of any medical device with their healthcare provider.
Earlier recalls of Medtronic SCS devices and products:
Patients have reported a range of problems with Medtronic SCS devices after implantation. The reported problems vary in severity, and in some cases, patients allege that complications required revision or removal surgery. Medtronic SCS device problems reported in lawsuits and FDA adverse event data:
Medtronic is facing legal scrutiny over its spinal cord stimulator devices. According to legal filings, the devices have undergone a number of design changes since their initial approval in 1984. Despite these changes, the company has not had to seek new Premarket Approval (PMA) or conduct new clinical trials. In total, it is believed that the company sought hundreds of PMA supplements, which may have “materially altered” the devices from their original state when approved by the FDA.
As reported in the publicly filed case Yates v. Medtronic (D. Minn., April 2025), the company sought alterations or PMA supplements, including:
Additional cases, including Keys v. Medtronic, have made similar allegations.
Medtronic is not only facing product liability claims but also scrutiny from state and federal regulators, paying millions to settle claims of kickbacks and False Claims Act violations. These settlements involved different Medtronic product lines (not the company’s spinal cord stimulators) and each was resolved without an admission of liability.
Medtronic’s regulatory issues and settlements:
Individuals who have suffered serious side effects or harm after having a Medtronic SCS device implanted may be able to take legal action. It is important to discuss your case with an experienced attorney who can help determine if you qualify for a Medtronic spinal cord stimulator lawsuit.
General eligibility factors for a Medtronic SCS lawsuit:
Individuals who have suffered harm after having a Medtronic SCS device implanted may be able to take legal action. These devices are intended to help manage chronic pain, but lawsuits allege that in some cases they instead worsened it. If you or a loved one experienced a complication related to a Medtronic SCS device, contact Wisner Baum today at (310) 207-3233 for a free consultation.
Wisner Baum has extensive experience handling defective medical devices and mass tort cases. We have represented thousands of families nationwide. Cases are accepted on a contingency fee basis, meaning there is no fee unless compensation is recovered on your behalf.
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Yes, multiple Medtronic SCS devices have been the subject of recalls over the last two decades. Recalled Medtronic devices include the Vanta, Intellis, and RestoreUltra/RestoreSensor products.
Yes, according to legal documents and FDA adverse event data, there have been several complications reported with Medtronic devices. These complications include lead migration, battery failure, burning sensations, shocks, and more.
Yes, multiple lawsuits have been filed against Medtronic, accusing the company of having dangerous or defective medical devices. In particular, the company has faced scrutiny related to its spinal cord stimulators.
Individuals who suffered harm after having a Medtronic spinal cord stimulator device installed may be able to file a lawsuit against the company. It is best to discuss legal options with an attorney as soon as possible.
In general, individuals have between one and three years from the date of injury or discovery to file a Medtronic SCS lawsuit. However, statutes of limitation are state-specific and should be discussed with an experienced attorney.
Allegations against Medtronic include that it made significant changes to its devices after Premarket Approval. Instead of going through a new approval process, the company filed PMA supplements. Some argue that the changes were material and should have gone through a more rigorous approval process, as well as new clinical testing.
