Medical procedure safety

Medical and dental procedures and your device

As a patient with a Spinal Cord Stimulator (SCS) system, it’s important to know your device. There are certain medical tests, therapies and procedures that may affect or permanently damage your SCS system. Some tests turn on or off the system as a result of magnetic imaging or other modalities. Tell your doctor about your SCS system before undergoing any type of test or procedure.

Procedures that may affect your SCS system

Diathermy

Diathermy emits a high-frequency electric current to stimulate heat generation within body tissue. The high energy and heat can be transferred through your stimulator system, causing tissue damage and, possibly, severe injury or even death.

Cardiac Pacemakers

A pacemaker or implantable cardiac defibrillator (ICD) may interfere with your SCS system.

Lithotripsy

Lithotripsy uses high-output sound or shock waves to treat gallstones and kidney stones and may interact with your device.

Electrocautery

Electrocautery uses a heated electric probe to stop bleeding during surgery and could interact with the SCS system.

External Defibrillation

External Defibrillation delivers an electrical shock to the heart to restore a normal heart rate. It is usually used in medical emergencies and may cause interference with SCS systems.

Radiation Therapy

Radiation is commonly used to treat cancer. Its ionizing energy may affect your SCS system.

Ultrasonic Scanning

Ultrasonic scanning tests use very high-frequency sound waves to produce images of internal organs or tissue.

High-Output Ultrasound

High-frequency sound waves may be used for physical therapy to treat certain bone/muscle injuries, for muscle stimulation or to improve blood flow.

X-Ray and CT Scans

These tests may damage the stimulator if stimulation is on, but they are unlikely to damage the device if stimulation is turned off.

MRI

MRI uses a strong electromagnetic field to produce images of the body. SCS systems differ when it comes to MRI scans and safety. Below is a list of guidelines for MRI and SCS. Learn about imaging options on pain.com.

SCS system allowing for head MRIs

Spectra WaveWriter™ Spinal Cord Stimulator System

This MRI conditional system allows you to have MRI scans of the head under specified conditions, if you meet the eligibility requirements.

SCS Systems allowing for full-body MRIs

WaveWriter Alpha™ Spinal Cord Stimulation Systems and Precision Montage™ MRI

This system provides access to full-body MRI scans, under specified conditions, if you meet the eligibility requirements.

MRI unsafe SCS systems

Precision™ Plus Spinal Cord Stimulator System and Precision Novi™ Spinal Cord Stimulator System

If you have either of these systems, you should not have an MRI. It may cause parts of the implant to dislodge, heat the neurostimulator or damage the implant, causing an uncomfortable or "jolting" sensation.

We’re here to help

Our patient services team is here to support you throughout your SCS journey.

(866) 360-4747

Available 6 am to 5 pm PT, Monday through Friday

Indications for Use: The Boston Scientific Spinal Cord Stimulator Systems are indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs including unilateral or bilateral pain associated with the following: failed back surgery syndrome, Complex Regional Pain Syndrome (CRPS) Types I and II, intractable low back pain and leg pain, Diabetic Peripheral Neuropathy of the lower extremities. Associated conditions and etiologies may be: radicular pain syndrome, radiculopathies resulting in pain secondary to failed back syndrome or herniated disc, epidural fibrosis, degenerative disc disease (herniated disc pain refractory to conservative and surgical interventions), arachnoiditis, multiple back surgeries.

Contraindications. The Spinal Cord Stimulator systems are not for patients who are unable to operate the system, have failed trial stimulation by failing to receive effective pain relief, are poor surgical candidates, or are pregnant.

Boston Scientific’s ImageReady™ MRI Technology makes safe MRI head scans possible. Patients implanted with the Precision Spectra™ or Spectra WaveWriter™ Spinal Cord Stimulator Systems with ImageReady™ MRI Technology are "MR Conditional" only when exposed to the MRI environment under the specific conditions defined in the applicable ImageReady™ MRI Head Only Guidelines for Precision Spectra™ or Spectra WaveWriter™ Spinal Cord Stimulator Systems.

Boston Scientific’s ImageReady™ MRI Full Body Technology makes safe MRI scans possible. The Precision Montage™ MRI, WaveWriter Alpha™ and WaveWriter Alpha™ Prime SCS Systems with ImageReady™ MRI Full Body Technology are “MR Conditional” only when exposed to the MRI environment under the specific conditions defined in the applicable ImageReady™ MRI Full Body Guidelines for Precision Montage™ MRI or WaveWriter Alpha™ and WaveWriter Alpha™ Prime Spinal Cord Stimulator Systems.

Warnings. Patients implanted with Boston Scientific Spinal Cord Stimulator Systems without ImageReady™ MRI Technology should not be exposed to Magnetic Resonance Imaging (MRI). Exposure to MRI may result in dislodgement of the stimulator or leads, heating of the stimulator, severe damage to the stimulator electronics and an uncomfortable or jolting sensation. As a Spinal Cord Stimulation patient, you should not have diathermy as either a treatment for a medical condition or as part of a surgical procedure. Strong electromagnetic fields, such as power generators or theft detection systems, can potentially turn the stimulator off, or cause uncomfortable jolting stimulation. The system should not be charged while sleeping. The Spinal Cord Stimulator system may interfere with the operation of implanted sensing stimulators such as pacemakers or implanted cardiac defibrillators. Advise your physician that you have a Spinal Cord Stimulator before going through with other implantable device therapies so that medical decisions can be made and appropriate safety measures taken. Patients using therapy that generates paresthesia should not operate motorized vehicles such as automobiles or potentially dangerous machinery and equipment with the stimulation on. Stimulation must be turned off first in such cases. For therapy that does not generate paresthesia (i.e. subperception therapy) it is less likely that sudden stimulation changes resulting in distraction could occur while having stimulation on when operating moving vehicles, machinery, and equipment. Your doctor may be able to provide additional information on the Boston Scientific Spinal Cord Stimulator systems. For complete indications for use, contraindications, warnings, precautions, and side effects, call 866.360.4747 or visit Pain.com.

Caution: U.S. Federal law restricts this device to sale by or on the order of a physician.

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