Spinal Cord Stimulator Fixed or Taken Out? Records That Show Why

What is a revision or a removal?

A revision is surgery to fix, move or replace part of a stimulator. A removal, also called an explant, takes it out. FDA says any implant can move, break or stop working, and more surgery may follow.

In one large 2026 review of 33 studies, revisions were more common than removals. It counted about 6 revisions and 3 removals for every 100 years of patient follow-up. About 1 in 10 patients had a lead move in a 2023 review.

A recall can mean a device is checked, adjusted or fixed. When an implant may fail, FDA says the company often asks doctors to talk with patients about the risks of taking it out and of leaving it in. Talk with your doctor before any change.

Why are stimulators fixed or taken out?

In studies, the most common reason for removal is pain relief that faded or never came. Lead problems and infection come next. Your surgeon’s notes may say why yours was done.

A study of 352 nerve stimulator removals at 18 U.S. centers found that 44% were for lack or loss of pain relief. Another 20% were for complications. A 2025 review of 25 studies found 38% for poor pain relief, 15% for lead failure and 14% for infection.

In one U.S. study of 1,014 implant surgeries over 10 years, about 1 in 10 needed another operation. A lead that moved or was placed wrong was the most common reason for a revision.

These studies describe groups of patients. They cannot tell you why your own device was fixed or removed.

Which records show what happened?

Ask for the surgery report, the device label or ID, X-rays or scans, and visit notes. Billing records help too, because they show dates. Your legal right to copies covers these when the office or hospital keeps them in your record.

Under HIPAA, the federal privacy law, your record set includes medical records, billing records, lab results and images such as X-rays. Ask for the unique device identifier, or UDI, of each part taken out or put in. It shows the model, and often the lot or serial number.

Records may sit with more than one doctor. In one study, 18% of patients had their device removed by a different doctor than the one who placed it. Ask each office and hospital that treated you.

Also keep your own notes. Write down when each problem began, what was done and who did it.

How do I get copies of my records?

Ask each provider in writing. They normally have up to 30 days to respond. You can usually get copies in the form you want, such as by email.

A provider may take up to 30 more days, one time. To do that, it must tell you in writing within the first 30 days why, and when you will get your records. If your records are kept electronically, a per-page fee is not allowed. You do not have a right to see a provider’s psychotherapy notes.

If you think something in your record is wrong, you can ask for a change. If the provider says no, you can add a written statement of disagreement to your record.

What happens to a device that is taken out?

If you and your doctor have already planned surgery, ask what will happen to any part that is taken out. FDA says device reports alone rarely prove what caused a problem. It is even harder when no one has examined the device.

In the Boston Scientific case, the parties told the court that devices are being removed while the case goes on. The people suing and Boston Scientific said they will soon start work on an order to save removed devices. As of September 30, 2026, no such order had been entered.

You can report a device problem to FDA through MedWatch yourself; your doctor does not have to do it. Patients can use a simpler form, called Form FDA 3500B. Device makers must tell FDA when they learn their device may have caused or added to a death or serious injury.