Prescription And Safety Information; Intended Use; Indication For Use; Contraindications - Abbott Eterna 32400 Clinician Manual

Prescription and Safety Information

Read this section to gather important prescription and safety information.

Intended Use

The Eterna™ Spinal Cord Stimulation (SCS) System is designed to deliver low-intensity electrical impulses to
nerve structures. The system is intended to be used with leads and associated extensions that are
compatible with the system.

Indication for Use

The Eterna™ SCS System is 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 and intractable low back and leg pain.

Contraindications

The Eterna™ SCS System is contraindicated for patients who are unable to operate the system or who have
failed to receive effective pain relief during trial stimulation.

Clinical Studies

Clinical studies were conducted to assess the safety and effectiveness of spinal cord stimulation (SCS)
systems. For information that supports the clinical use of neurostimulation systems and the anatomical
placement of leads, refer to the clinical summaries manual for SCS.

MRI Safety Information

Some models of this system are Magnetic Resonance (MR) Conditional, and patients with these devices may
be scanned safely with magnetic resonance imaging (MRI) when the conditions for safe scanning are met.
For more information about MR Conditional neurostimulation components and systems, including
equipment settings, scanning procedures, and a complete listing of conditionally approved components,
refer to the MRI procedures clinician's manual for neurostimulation systems (available online at
medical.abbott/manuals). For more information about MR Conditional products, visit the Abbott Medical
product information page at neuromodulation.abbott/MRI-ready.

Warnings

The following warnings apply to this neurostimulation system.
Poor surgical risks. Neurostimulation should not be used on patients who are poor surgical candidates.
Neurostimulation should not be used for patients with comorbidities that could prevent successful implant
or effective therapy.
Magnetic resonance imaging (MRI). Some patients may be implanted with the components that make up a
Magnetic Resonance (MR) Conditional system, which allows them to receive an MRI scan if all the
requirements for the implanted components and for scanning are met. A physician can help determine if a
patient is eligible to receive an MRI scan by following the requirements provided by Abbott Medical.
Physicians should also discuss any risks of MRI with patients.
Patients without an MR Conditional neurostimulation system should not be subjected to MRI because the
electromagnetic field generated by an MRI may damage the device electronics and induce voltage through
the lead that could jolt or shock the patient.
Diathermy therapy. Do not use short-wave diathermy, microwave diathermy, or therapeutic ultrasound
diathermy (all now referred to as diathermy) on patients implanted with a neurostimulation system. Energy
from diathermy can be transferred through the implanted system and cause tissue damage at the location
of the implanted electrodes, resulting in severe injury or death.
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