SAFETY INFORMATION

Indications for Use

The SPRINT Peripheral Nerve Stimulation (PNS) System is indicated for up to 30 days in the back and/or extremities for:

  • Symptomatic relief of chronic, intractable pain, post surgical and post-traumatic acute pain;
  • Symptomatic relief of post-traumatic pain;
  • Symptomatic relief of post-operative pain

The Sprint PNS System is not intended to treat pain in the craniofacial region.

Contraindications

Use of the Sprint System is contraindicated for:

  • Patients who have a deep brain stimulation (DBS) system, an implanted active cardiac implant, or any other implantable neurostimulator whose stimulus current pathway may overlap the Sprint Stimulator’s current pathway.
  • Patients who require Magnetic Resonance Imaging (MRI). The Sprint MicroLead and other Sprint components must be removed from the body prior to an MRI.
  • Patients who have a tape or adhesive allergy.

The most common adverse events reported in clinical studies included skin irritation and erythema. The majority of the adverse events were resolved with little to no intervention within a few days, and none were classified as serious.


MRI Safety Information


THE SPRINT PNS SYSTEM IS MR UNSAFE

The SPRINT PNS System is MR unsafe.
All MRI procedures, no matter the anatomic site, are contraindicated for patients with the Sprint PNS System. Exposure can cause tissue heating and injury or unwanted stimulation. Remove the lead and all other system components from the patient before an MRI examination is performed. In the case of a lead fracture beneath the skin resulting in a retained lead fragment, an MRI examination is safe to perform under the conditions described in the MR Conditional statement below.


A RETAINED LEAD FRAGMENT ONLY IS MR CONDITIONAL

A retained lead fragment ONLY is MR conditional.
Non-clinical testing demonstrated that a retained lead fragment entirely beneath the skin is MR conditional. A patient with a retained lead fragment can be scanned safely in an MR system under the following conditions:

  • Static magnetic field of 1.5-Tesla only
  • Maximum spatial gradient magnetic field of 1,000-Gauss/cm (10 T/m)
  • Maximum MR system reported whole body averaged specific absorption rate (SAR) of 2 W/kg for 15 minutes of scanning (Normal Operating Mode)

Under the scan conditions defined above, the fragment is expected to produce a maximum temperature rise of less than 3.3°C after 15 minutes of continuous scanning.

In non-clinical testing, the image artifact caused by a fragment extends approximately 7mm from the fragment when imaged using a gradient echo pulse sequence and a 1.5-Tesla MR system.

Note: There should be no section of lead visible above the skin.

Note: If a lead is placed in an individual with an existing retained lead fragment, the new lead should not be placed in a location where it could touch the original lead fragment. During MRI, two lead fragments touching each other can result in an increase in temperature of the lead fragments and surrounding tissue where they touch.