Injury guide

Spinal cord stimulator removal

Updated Oct 6, 202621 sources

A spinal cord stimulator is an implant that uses mild current to ease pain. Here is why one may be fixed or taken out, which records matter, and what the lawsuits claim.

What the public record says

These are cited sources. Their inclusion does not imply that they endorse People’s Justice or reviewed this page.

The evidence and its limits

Summit Pain Alliance, Santa Rosa, California (first author); 18 U.S. centers · Neuromodulation · 2017

Multicenter study of stimulator removals

Design:
Other study design
Participants:
A look back at the charts of 352 people whose nerve stimulators were taken out at 18 U.S. centers.
Finding:
Loss or lack of pain relief was the top reason for removal (43.9%), followed by complications (20.2%). In 18%, a different doctor took the device out than the one who put it in.
Main limitation
It only studied people whose devices came out, so it cannot give a removal rate. Reasons come from chart notes, and only the abstract was read.

Read the source: Multicenter study of stimulator removals (opens in a new tab) · Checked Oct 6, 2026

Montefiore Medical Center (first author) · Journal of Pain Research · 2025

Review of stimulator removal studies

Design:
Other study design
Participants:
25 studies with 13,026 people who got a permanent stimulator between 1984 and 2024.
Finding:
About 9.8% had the device removed. Poor pain relief (38%), lead failure (15%) and infection (14%) were the top reasons. Most removals came in the first year.
Main limitation
It pools many kinds of studies over 40 years, and only the abstract was read. Some authors report ties to stimulator makers. It cannot explain why any one person’s device came out.

Read the source: Review of stimulator removal studies (opens in a new tab) · Checked Oct 6, 2026

The short answer

What is spinal cord stimulator removal, and why is it done?
A spinal cord stimulator sends a mild electric current to block pain signals in the spine. Thin wires, called leads, sit near the spinal cord, and a small battery unit sits under the skin. Removal, also called explant, takes the device out. A revision is surgery to fix or replace part of it. [1]
When should I talk to my doctor about spinal cord stimulator removal?
Talk to your doctor if your pain relief fades, if the device sends too strong a signal or stops working, or if the site looks infected. Only you and your doctor can decide whether to fix it, take it out or leave it. A recall does not always mean an implant must come out. [1]
How is a stimulator taken out or fixed, and how are problems treated?
Some problems need more surgery. A wire that breaks or moves, or a damaged battery unit, may need surgery to fix. If the site gets infected, the device usually has to come out. [1]
Which records matter after spinal cord stimulator removal?
Ask for the report from each surgery. It is called the operative report. Federal rules for hospitals say it must tell what the surgeon did, what was found and what was taken out. FDA also told doctors to give each patient the maker, model and UDI code of the device. [2]

What rules a case out

Not covered by this case

  • This page is not medical advice. Talk to your doctor about what to do about your stimulator.
  • It does not cover other kinds of nerve stimulators.

What is spinal cord stimulator removal, and why is it done?

A spinal cord stimulator sends a mild electric current to block pain signals in the spine. Thin wires, called leads, sit near the spinal cord, and a small battery unit sits under the skin. Removal, also called explant, takes the device out. A revision is surgery to fix or replace part of it.

People get a stimulator after other care, such as medicine and exercise, has not helped. A short trial comes first. If the trial greatly eases the pain, you may be offered a lasting device.

A battery unit that cannot be recharged lasts about 2 to 5 years. Replacing it takes another surgery.

When should I talk to my doctor about spinal cord stimulator removal?

Talk to your doctor if your pain relief fades, if the device sends too strong a signal or stops working, or if the site looks infected. Only you and your doctor can decide whether to fix it, take it out or leave it. A recall does not always mean an implant must come out.

Never have a device removed just for a lawsuit. Surgery to take out an implant has its own risks, such as infection. If a device is ever recalled, FDA says, the maker often asks doctors to reach out and weigh removal against keeping the device.

Bring a list of questions to the visit. Ask what each choice could mean for your pain and your daily life.

How is a stimulator taken out or fixed, and how are problems treated?

Some problems need more surgery. A wire that breaks or moves, or a damaged battery unit, may need surgery to fix. If the site gets infected, the device usually has to come out.

FDA lists the risks of taking out any implant: the risks of surgery itself, and infection. It also warns that implants can shift, break or fail as years pass.

Which records matter after spinal cord stimulator removal?

Ask for the report from each surgery. It is called the operative report. Federal rules for hospitals say it must tell what the surgeon did, what was found and what was taken out. FDA also told doctors to give each patient the maker, model and UDI code of the device.

A UDI names the company on the label and the exact model, and it can show the lot or batch. A stimulator has more than one part, so ask about each lead and the battery unit.

Ask whether the removed parts were kept, and where they went. FDA’s device problem form asks whether the device can still be checked and whether it went back to the maker. In the Boston Scientific cases, the parties told the court in September 2026 that they plan to work on an order to keep removed devices.

Ask whether any removed part or tissue was sent to the lab. If so, ask for the pathology report as well. It is written by a pathologist, a doctor who studies cells and tissue under a microscope.

The doctor who took the device out may not be the one who put it in. So ask every office and hospital that treated you. You have a right to copies, and our records request tool can help you ask.

What does research say about stimulator removal?

Studies find that some stimulators come out, most often because they did not ease pain enough. In a review of 25 studies with over 13,000 people, about 1 in 10 had the device removed. Most removals happened in the first year.

In that review, lead failure and infection were the next most common reasons. A 2026 review of 33 studies found revision surgeries about twice as common as removals, though results varied a lot between studies.

In 2020, FDA said it kept getting reports of serious side effects with these devices. In reports from 2016 to 2020, poor pain relief was the most common patient problem. FDA notes that these reports do not show how many patients have a problem. It also says cause is hard to judge when no one has checked the device.

The court groups for these lawsuits formed in 2026, and court papers so far describe what the people suing claim. In the federal court records we read, we found no ruling that any stimulator caused an injury.

Who brings stimulator claims in these cases?

People who got a Boston Scientific, Abbott or Nevro stimulator and say they were hurt brought these cases. Claimed harms include poor pain relief, burning, shocks and leads that moved. A lawyer can look at your records and tell you if you may have a claim.

Each maker’s cases are grouped before a different federal judge. The spinal cord stimulator case page explains each group.

Can a family member get records after stimulator surgery?

Yes, in some cases. Under HIPAA, a personal representative stands in for the patient. That can be someone named in a health care power of attorney, or a parent of a minor.

After a death, the person who runs the estate, such as an executor, can get the records the estate needs. A care team may share facts with family who helped with care, limited to that help. State law sets the details.

If someone has died, see the wrongful death case page for a general look at how those claims work.

Sources

  1. MedlinePlus: Spinal cord stimulation
  2. eCFR: 42 CFR 482.51, hospital surgical services (operative reports)
  3. Wahezi et al., Journal of Pain Research, 2025
  4. JPML transfer order, Boston Scientific stimulator MDL No. 3181 (June 5, 2026)
  5. JPML transfer order, Abbott stimulator MDL No. 3194 (Oct. 2, 2026)JPML transfer order, Abbott stimulator MDL No. 3194 (Oct. 2, 2026) · court
  6. JPML transfer order, Nevro stimulator MDL No. 3195 (Oct. 2, 2026)JPML transfer order, Nevro stimulator MDL No. 3195 (Oct. 2, 2026) · court
  7. FDA: Implants and prostheticsFDA: Implants and prosthetics · regulator
  8. FDA: Letter to health care providers on spinal cord stimulator trials (2020, archived)FDA: Letter to health care providers on spinal cord stimulator trials (2020, archived) · regulator
  9. FDA: What is a medical device recall?FDA: What is a medical device recall? · regulator
  10. MedlinePlus: Talking with your doctorMedlinePlus: Talking with your doctor · regulator
  11. FDA: UDI basicsFDA: UDI basics · regulator
  12. FDA: MedWatch Form 3500 (device problem report)FDA: MedWatch Form 3500 (device problem report) · regulator
  13. C.D. Cal.: Boston Scientific stimulator MDL joint status report (Sept. 30, 2026)C.D. Cal.: Boston Scientific stimulator MDL joint status report (Sept. 30, 2026) · court
  14. NCI: Pathology reportsNCI: Pathology reports · regulator
  15. Pope et al., Neuromodulation, 2017Pope et al., Neuromodulation, 2017 · study
  16. HHS: Your right to access your health informationHHS: Your right to access your health information · regulator
  17. Raccagni et al., Neuromodulation, 2026Raccagni et al., Neuromodulation, 2026 · study
  18. FDA: About the MAUDE device report databaseFDA: About the MAUDE device report database · regulator
  19. HHS: Personal representatives under HIPAAHHS: Personal representatives under HIPAA · regulator
  20. eCFR: 45 CFR 164.502(g), personal representativeseCFR: 45 CFR 164.502(g), personal representatives · regulator
  21. HHS: Health information of deceased individualsHHS: Health information of deceased individuals · regulator

Checked against 21 primary sources by People's Justice editors · Updated

How we make money