Chapter 1: Introduction
6
| SPRINT
®
PNS System – Clinician Instruction for Use [L0090-MAN-000 Rev F]
1
Introduction
1.1) Indications for Use
The SPRINT
®
Peripheral Nerve Stimulation (PNS) System is indicated for up to 60 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.
A randomized controlled trial failed to show that the SPRINT
®
PNS System was effective for post-stroke
shoulder pain.
1.2) Contraindications
•
Use of the SPRINT
®
PNS System is contraindicated for:
-
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 a tape or adhesive allergy.
1.3) Warnings
Refer to the warnings below before using the system. Additional warnings specific to home use are
included in the Patient Instructions for Use (Section 2: Important Safeguards).
SPRINT PNS System placement
The Sprint PNS System is for use in the back and/or extremities.
The Sprint PNS System is not intended to treat pain in the
craniofacial region.
Do not place the SPRINT Mounting Pad on the head or on the
front of the throat. Stimulation in these areas may cause severe
muscle spasms resulting in closure of the airway, difficulty
breathing, or adverse effects on heart rhythm or blood pressure.
Do not apply stimulation across the chest; introduction of
electrical current into the chest may cause rhythm disturbances
to the heart, which could be lethal.
