Prescription And Safety Information; Intended Use; Indications For Use; Contraindications - St.Jude Medical Proclaim Manuel

Prescription and Safety Information

Read this section to gather important prescription and safety information.

Intended Use

This neurostimulation 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.

Indications for Use

This neurostimulation 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

This system is contraindicated for patients who are unable to operate the system or who have
failed to receive effective pain relief during trial stimulation.

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 manuals.sjm.com). For more information about MR
Conditional products, visit the St. Jude Medical product information page at
sjmprofessional.com/MRI.

Warnings

The following warnings apply to these components.
Poor surgical risks. Neurostimulation should not be used on patients who are poor surgical risks
or patients with multiple illnesses or active general infections.
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 St. Jude 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.
Diathermy is further prohibited because it may also damage the neurostimulation system
components. This damage could result in loss of therapy, requiring additional surgery for system
implantation and replacement. Injury or damage can occur during diathermy treatment whether
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