Precautions - St.Jude Medical Proclaim Manuel

the neurostimulation system is turned on or off.
Electrosurgery devices. Electrosurgery devices should not be used in close proximity to an
implanted neurostimulation system. Contact between an active electrode and an implanted IPG,
lead, or extension can cause severe injury to the patient. If use of electrocautery is necessary, first
turn off the neurostimulation system.
Implanted cardiac systems. Physicians need to be aware of the risk and possible interaction
between a neurostimulation system and an implanted cardiac system, such as a pacemaker or
defibrillator. Electrical pulses from a neurostimulation system may interact with the sensing
operation of an implanted cardiac system, causing the cardiac system to respond inappropriately.
To minimize or prevent the implanted cardiac system from sensing the output of the
neurostimulation system, (1) maximize the distance between the implanted systems; (2) verify
that the neurostimulation system is not interfering with the functions of the implanted cardiac
system; and (3) avoid programming either device in a unipolar mode (using the device's can as
an anode) or using neurostimulation system settings that interfere with the function of the
implantable cardiac system.
Pediatric use. Safety and effectiveness of neurostimulation for pediatric use have not been
established.
Pregnancy and nursing. Safety and effectiveness of neurostimulation for use during pregnancy
and nursing have not been established.
Device components. The use of non-St. Jude Medical components with this system may result in
damage to the system and increased risk to the patient.
Case damage. Do not handle the IPG if the case is pierced or ruptured because severe burns
could result from exposure to battery chemicals.
IPG disposal. Return all explanted IPGs to St. Jude Medical for safe disposal. IPGs contain
batteries as well as other potentially hazardous materials. Do not crush, puncture, or burn the IPG
because explosion or fire may result.

Precautions

The following precautions apply to these components.
General Precautions
Clinician training. Implanting physicians should be experienced in the diagnosis and treatment of
chronic pain syndromes and have undergone surgical and device implantation training.
Patient selection. It is extremely important to select patients appropriately for neurostimulation.
Thorough psychiatric screening should be performed. Patients should not be dependent on drugs
and should be able to operate the neurostimulation system.
Infection. Follow proper infection control procedures. Infections related to system implantation
might require that the device be explanted.
Electromagnetic interference (EMI). Some equipment in home, work, medical, and public
environments can generate EMI that is strong enough to interfere with the operation of a
neurostimulation system. Patients should avoid getting too close to these types of EMI sources,
which include the following examples: commercial electrical equipment (such as arc welders and
induction furnaces), communication equipment (such as microwave transmitters and high-power
amateur transmitters), high-voltage power lines, and some medical procedures (such as
therapeutic radiation and electromagnetic lithotripsy).
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