Indications for use
The SPRINT Peripheral Nerve Stimulation (PNS) System is indicated for up to 60 days 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 be placed in the region innervated by the cranial and facial nerves.
Contraindications
Use of the SPRINT® PNS System is contraindicated for:
- Lead placement over the heart or across the thoracic volume.
- Lead placement in the front or side of the neck.
- Lead placement on the top of the head.
- Patients who have a Deep Brain Stimulation (DBS) system.
- Patients who have an implanted active cardiac implant (e.g. pacemaker or defibrillator).
- Patients who have any other implantable neuro-stimulator whose stimulus current pathway may overlap with that of the SPRINT System.
- Patients who require Magnetic Resonance Imaging (MRI). The SPRINT MicroLead™ and other SPRINT components must be removed from the body before an MRI.
- Patients who have epilepsy, if the leads are intended to be placed in the head or neck.
- Patients who have a tape or adhesive allergy.
Adverse events (Side Effects)
The most common device-related adverse event reported in clinical studies was skin irritation (which may include inflammation, mild blistering, and/or erythema). Other less-reported events included itching at the electrode exit site, granuloma, pain after electrode placement, and infection. The majority of the device-related adverse events in sponsored clinical studies were resolved with little to no intervention within a few days, and none were classified as serious.
Similar adverse events have been reported during commercial use. Infections have been reported for about 1-2% of patients. Serious adverse events have been rare.
MRI safety information
NOTE: Patients that received a SPRINT System prior to September 1st, 2022, should contact SPR Therapeutics to obtain specific MRI safety information. (Phone: 844-378-9108)
All other SPRINT patients should use the information listed below:
The SPRINT PNS System is MR Unsafe. – All MRI procedures, no matter the anatomic site, are contraindicated for patients with SPRINT PNS System. Exposure can cause tissue heating and injury or unwanted stimulation. Pull out the Lead and remove 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 remnant, an MRI examination is safe to perform under the conditions described in the MR Conditional statement below.
A retained Lead Remnant ONLY is MR Conditional. – A person with a retained Lead remnant may be safely scanned anywhere in the body at 1.5T or 3.0T under the following conditions. Failure to follow these conditions may result in injury.
Full MRI safety information is available here:
