Spinal Cord Stimulator Recalls & FDA Reports

Between July 2016 and July 2020, the FDA received 107,728 medical device reports related to spinal cord stimulators, including reports associated with 497 patient deaths, 77,937 injuries, and 29,294 device malfunctions. Since 2010, the agency has issued more than 40 recalls of spinal cord stimulation devices from multiple manufacturers, including at least one Class I recall — the FDA's most serious designation.

The FDA's September 2020 Safety Communication

On September 3, 2020, the FDA published a letter to healthcare providers titled "Conduct a Trial Stimulation Period Before Implanting a Spinal Cord Stimulator (SCS)." The letter was the result of the agency's ongoing monitoring of adverse event reports and published literature related to implanted spinal cord stimulators.

While the letter's primary recommendation — that physicians should conduct a trial stimulation period before permanent implantation, as already required by device labeling — may seem straightforward, the safety data the FDA disclosed alongside it was not. The agency revealed that over the preceding four years, it had received 107,728 medical device reports involving spinal cord stimulators. Of those, 497 were associated with patient deaths, 77,937 involved injuries, and 29,294 reported device malfunctions.

The FDA also disclosed that 30,321 of those reports — approximately 28 percent — cited unsatisfactory pain relief as the primary concern. In other words, nearly one in three adverse event reports involved a device that simply did not work as intended after permanent implantation.

The September 2020 communication did not mandate any new restrictions on spinal cord stimulator sales or impose additional clinical testing requirements. It did not name specific manufacturers or device models. Instead, the agency reminded healthcare providers to follow existing device labeling instructions and encouraged patients and clinicians to report problems through the FDA's MedWatch system.

Adverse Event Data by the Numbers

The 2020 safety communication covered a four-year window, but the full scope of adverse event reporting for spinal cord stimulators extends well beyond that period. According to FDA data compiled in the pending federal lawsuits, between 2004 and 2019 the agency received a total of 220,374 medical device reports related to SCS devices, including 156,817 injury reports and 931 reports associated with patient deaths.

To put these numbers in context, an estimated 50,000 spinal cord stimulators are implanted annually in the United States. The manufacturers named in the current litigation — Abbott and Boston Scientific — hold a combined majority share of this market, along with Medtronic and Nevro.

The table below summarizes the publicly reported FDA adverse event data across the two time periods most commonly referenced in the litigation and safety communications.

It is important to note that adverse event reports submitted to the FDA do not, on their own, prove that a device caused a particular injury or death. The MAUDE database includes reports from manufacturers, healthcare facilities, and voluntary reporters, and the reported events may involve patients with pre-existing conditions or other complicating factors. However, the volume and consistency of these reports are a central element of the plaintiffs' claims in the pending litigation, and they formed the basis for the FDA's decision to issue its 2020 safety communication.

The MAUDE Database and How Adverse Events Are Reported

The FDA's Manufacturer and User Facility Device Experience (MAUDE) database is the public repository for medical device reports (MDRs) submitted to the agency. It is searchable online and contains reports spanning the most recent ten years, with older data available through downloadable files.

Three types of reporters are required by law to submit medical device reports to the FDA. Device manufacturers must report whenever they become aware of information suggesting their device may have caused or contributed to a death or serious injury, or that the device has malfunctioned in a way that would likely cause or contribute to such outcomes if the malfunction recurred. Importers of medical devices have a similar mandatory reporting obligation. Healthcare facilities (hospitals, nursing homes, outpatient treatment facilities) are required to report device-related deaths to both the FDA and the manufacturer, and device-related serious injuries to the manufacturer.

In addition to these mandatory reporters, any individual — including patients, family members, and healthcare professionals — may submit a voluntary report through the FDA's MedWatch program. Because reporting by patients is voluntary and many patients may not be aware of the system, the actual number of adverse events associated with spinal cord stimulators is widely believed to be higher than what the MAUDE database reflects. Multiple studies have found that medical device adverse events are significantly underreported.

How to Search the MAUDE Database

Patients and attorneys can search the MAUDE database directly through the FDA's website at accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/search.cfm. Spinal cord stimulator reports can be found by searching for product codes LGW (stimulator, spinal-cord, totally implanted for pain relief) and GZB (stimulator, spinal-cord, implanted for pain relief). Reports can be filtered by manufacturer, date range, and event type.

Abbott SCS Recalls and Safety Actions

Abbott (which acquired St. Jude Medical in January 2017, along with its spinal cord stimulator product line) has been the subject of multiple FDA recalls and safety actions involving its SCS devices. The most significant recent action was a Class I recall issued in September 2023.

Abbott has also faced earlier recall actions. In 2011, St. Jude Medical (prior to the Abbott acquisition) recalled its Eon and Eon Mini implantable pulse generators after internal battery weld failures caused devices to leak electrolyte, resulting in charging failures, overheating during recharging, and therapy interruptions that in some cases required emergency explant surgery.

Boston Scientific SCS Recalls and Safety Actions

Boston Scientific has been the subject of multiple FDA recalls and product advisories involving its spinal cord stimulator line, including the Precision, Precision Spectra, and WaveWriter Alpha systems.

The WaveWriter Alpha advisory came on top of a longer history of safety actions involving Boston Scientific's SCS products. The Precision Spinal Cord Stimulator System, originally approved in 2004, has been the subject of multiple Class II recalls over the years, including actions related to lead connection failures, software errors, and IPG malfunctions.

Separately, lawsuits filed against Boston Scientific allege that the company's spinal cord stimulator products — including the Precision, Precision Montage MRI, Precision Spectra, and WaveWriter Alpha — have caused lead migration, burning sensations, battery failures, and device malfunctions that were not adequately disclosed to physicians or patients. The pending litigation contends that Boston Scientific used the PMA supplement pathway to introduce substantial device modifications without undergoing the clinical testing that a full PMA submission would require.

Timeline of Key FDA Actions

The following timeline summarizes the major FDA safety communications, recalls, and regulatory actions related to spinal cord stimulators from both Abbott and Boston Scientific.

Public Citizen and External Criticism of FDA Oversight

The FDA's handling of spinal cord stimulator regulation has drawn sustained criticism from consumer safety organizations, researchers, and investigative journalists — criticism that predates the current lawsuits and provides context for the litigation's claims about regulatory failure.

In June 2020, three months before the FDA published its safety communication, the consumer advocacy group Public Citizen released a report calling the agency's oversight of spinal cord stimulators "dangerously lax." The report specifically criticized the PMA supplement process that allowed manufacturers to introduce significant device modifications without submitting new clinical trial data. Public Citizen called on the FDA to require original PMA submissions for all new SCS device models, reassess whether any currently approved SCS devices should be removed from the market, and reclassify spinal cord stimulators to impose stricter regulatory standards.

The pending federal lawsuits incorporate many of the same arguments raised by Public Citizen. Plaintiffs allege that both Abbott and Boston Scientific used serial PMA supplements to introduce major design changes — including new stimulation waveforms, redesigned lead systems, updated battery architectures, and wireless controller technology — without the clinical testing that a full PMA application would have required. The lawsuits further allege that the FDA facilitated this process by treating each supplement as a minor modification rather than a substantial change requiring independent safety review.

Notably, the lawsuits name the FDA itself as a defendant under the Administrative Procedure Act (APA), alleging that the agency's approval process for SCS device supplements was arbitrary and capricious. This is an unusual legal theory in product liability litigation and reflects the centrality of the regulatory approval process to the plaintiffs' claims.

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