Spinal Cord Stimulator Reprogramming Caused Electric Shocks, Worsening Pain: Lawsuit

Abbott sales representatives’ unlicensed attempts at medical treatment left plaintiff repeatedly writhing on the floor and spasming while being electrocuted.

A Florida man has filed a spinal cord stimulator lawsuit alleging Abbott Laboratories’ customer service and sales representatives repeatedly caused him to suffer severe, disabling pain while making medical adjustments to his implant without proper training or licenses.

The complaint (PDF) was brought by Joel Sampson in the U.S. District Court for the Middle District of Florida on July 21, naming Abbott Laboratories and the U.S. Food and Drug Administration (FDA) as the defendants.

Sampson indicates he was implanted with Abbott’s Proclaim system spinal cord stimulator for the treatment of chronic pain. However, he claims the implant’s defective design caused painful neurological symptoms, requiring revision surgery. Despite having the device removed, Sampson says he has suffered permanent injuries.

Spinal Cord Stimulator Complications

The Proclaim system is one of numerous spinal cord stimulators currently offered by several major medical device manufacturers, including Abbott, Boston Scientific, Medtronic and Nevro. The devices consist of electrodes and a battery-powered pulse generator implanted under the skin, along with an external remote used to adjust the electrical stimulation intended to interrupt pain signals before they reach the brain.

The devices are promoted as a permanent treatment option for patients whose chronic pain has not improved through medication, physical therapy or other forms of care.

However, a growing number of recipients have since reported battery failures, unexpected shutdowns, painful electric shocks, burning sensations, worsening pain and incidents where leads or pulse generators migrated or pierced the skin. These complications have resulted in reports of infections, nerve damage and additional surgery to reprogram, revise or remove the implant.

As a result, spinal cord stimulator lawsuits are now being filed raising allegations that many revised models were allowed onto the market through FDA regulatory pathways that did not require manufacturers to conduct extensive new clinical testing to establish the safety of each modified device before it was implanted in patients.

The lawsuits claim manufacturers failed to adequately test the implants or warn patients and physicians that they could malfunction and cause serious injuries. Some complaints, including Sampson’s, also raise concerns about the prominent role of company representatives, alleging they overstated the devices’ potential benefits, minimized known risks and adjusted programming without the medical qualifications necessary to provide patient care.

Spinal Cord Stimulator Injury Allegations

According to the lawsuit, Sampson received a Proclaim XR5 SCS system in January 2021 for the treatment of chronic pain. Before receiving the permanent implant, he was placed through a trial period with a temporary device, which Abbott sales representatives told him would operate the same as the permanent implant.

The device worked fine for the first three years, but stopped relieving pain suddenly in August 2024, Sampson states. When he reported the problem, an Abbott sales representative told Sampson he could guide him through the reprogramming process to make the device effective again.

The complaint indicates that the first couple tries at reprogramming seemed to have no effect. On the third attempt, the implant began to electrocute Sampson.

“Plaintiff was in such excruciating pain due to his back spasms caused by the electrocution, all he could do was writhe on the floor for three minutes. During this time, Plaintiff was physically incapable of reaching his controller to turn off the device.”

– Joel Sampson v. Abbott Laboratories et al.

Sampson’s daughter found him on the floor, spasming, and turned off the device while the sales representative apologized over the phone. However, he continued to spasm well after the device was shut down.

The lawsuit notes that the spinal cord stimulator was set to 66, despite a normal setting being between 35 to 45 during the day, and between 15 and 21 at night. Sampson suffered from back and kidney pain, as well as constant diarrhea, for the next two weeks.

In October 2024, another sales representative called to have Sampson’s settings adjusted, this time meeting him at a Florida clinic. At the meeting, the sales representative reportedly told Sampson that his device had never been recalled, until Sampson presented paperwork showing that it had.

The representative then proceeded to attempt reprogramming the device twice more without a doctor present, which again left Sampson spasming on the floor in pain.

Sampson indicates the Abbott employee determined that the device was malfunctioning and also noted that it needed to be surgically removed before Sampson could have an MRI.

On April 9, 2025, Sampson’s Proclaim system was surgically removed due to mechanical and therapeutic failure. He still suffers the original chronic pain and new injuries caused by the allegedly defective spinal cord stimulator.

The lawsuit presents claims of manufacturing defect, failure to warn, negligence per se, breach of warranty, negligence, negligent misrepresentation, fraudulent concealment, unauthorized practice of medicine and violations of the Administrative Procedure Act. It seeks compensatory and punitive damages.

Spinal Cord Stimulator Lawsuits

Due to a series of similar Abbott Laboratories spinal cord stimulator lawsuits being filed in federal courts nationwide, plaintiffs previously sought to have all of the Abbott Laboratory SCS lawsuits consolidated into a multidistrict litigation for coordinated pretrial proceedings. However, the U.S. Judicial Panel on Multidistrict Litigation denied such a petition in June, indicating that Abbott SCS lawsuits do not need to be consolidated at this time.

The panel did agree to consolidate all federal Boston Scientific spinal cord stimulator lawsuits, which have been centralized in the Central District of California before U.S. District Judge Josephine L. Staton for coordinated discovery and pretrial proceedings.

Spinal cord stimulator lawyers are continuing to review potential claims for individuals, regardless of brand, who suffered any of the following injuries due to spinal cord stimulators:

To find out whether you or a loved one may qualify for a spinal cord stimulator lawsuit, submit information to receive a free case review by a lawyer. All claims are handled on a contingency fee basis, which means there are no fees or expenses unless a recovery is obtained.

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