Abbott Eterna 32400 - Prescription and Safety Information; Intended Use, Indications, and Contraindications; MRI Safety Information; Warnings

Prescripon and Safety Informaon
Read this secon to gather important prescripon and safety informaon.
Intended Use
The Eterna™ Spinal Cord Smulaon (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
compable with the system.
Indicaon 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.
Contraindicaons
The
Eterna
™ SCS System is contraindicated for paents who are unable to operate the system or who have
failed to receive eecve pain relief during trial smulaon.
Clinical Studies
Clinical studies were conducted to assess the safety and eecveness of spinal cord smulaon (SCS)
systems. For informaon that supports the clinical use of neurosmulaon systems and the anatomical
placement of leads, refer to the clinical summaries manual for SCS.
MRI Safety Informaon
Some models of this system are Magnec Resonance (MR) Condional, and paents with these devices may
be scanned safely with magnec resonance imaging (MRI) when the condions for safe scanning are met.
For more informaon about MR Condional neurosmulaon components and systems, including
equipment sengs, scanning procedures, and a complete lisng of condionally approved components,
refer to the MRI procedures clinician's manual for neurosmulaon systems (available online at
medical.abbo/manuals
). For more informaon about MR Condional products, visit the
Abbo Medical
product informaon page at neuromodulaon.abbo/MRI-ready.
Warnings
The following warnings apply to this neurosmulaon system.
Poor surgical risks. Neurosmulaon should not be used on paents who are poor surgical candidates.
Neurosmulaon should not be used for paents with comorbidies that could prevent successful implant
or eecve therapy.
Magnec resonance imaging (MRI). Some paents may be implanted with the components that make up a
Magnec Resonance (MR) Condional 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
paent is eligible to receive an MRI scan by following the requirements provided by Abbo Medical.
Physicians should also discuss any risks of MRI with paents.
Paents without an MR Condional neurosmulaon system should not be subjected to MRI because the
electromagnec eld generated by an MRI may damage the device electronics and induce voltage through
the lead that could jolt or shock the paent.
Diathermy therapy. Do not use short-wave diathermy, microwave diathermy, or therapeuc ultrasound
diathermy (all now referred to as diathermy) on paents implanted with a neurosmulaon system. Energy
from diathermy can be transferred through the implanted system and cause ssue damage at the locaon
of the implanted electrodes, resulng in severe injury or death.
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