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 treat pain 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
The most common device-related adverse events reported in clinical studies included skin irritation and erythema. The majority of the device-related 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.
A retained lead remnant ONLY is MR conditional.
Full MRI safety information is available in the MRI Safety Information section of the SPRINT PNS System Instructions for Use, which can be obtained by calling 1-844-378-9108.