User's Manual

Device modification.
The equipment is not serviceable by the customer. To prevent injury or
damage to the system, do not modify the equipment. If needed, return the equipment to St. Jude
Medical for service.
Component disposal.
Return all explanted components to St. Jude Medical for safe disposal.
Hospital and Medical Environments
High-output ultrasonics and lithotripsy.
The use of high-output devices, such as an
electrohydraulic lithotriptor, may cause damage to the electronic circuitry of an implanted IPG. If
lithotripsy must be used, do not focus the energy near the IPG.
Home and Occupational Environments
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, some medical procedures (such as therapeutic
radiation and electromagnetic lithotripsy), and some medical devices (such as bone growth
stimulators, transcutaneous electrical nerve stimulation [TENS] devices, dental drills, and
ultrasonic probes).
Wireless use restrictions.
In some environments, the use of wireless functions (e.g., Bluetooth
®
wireless technology) may be restricted. Such restrictions may apply aboard airplanes, in hospitals,
near explosives, or in hazardous locations. If you are unsure of the policy that applies to the use of
this device, please ask for authorization to use it before turning it on. (Bluetooth
®
is a registered
trademark of Bluetooth SIG, Inc.)
Security, antitheft, and radiofrequency identification (RFID) devices.
Some antitheft
devices, such as those used at entrances or exits of department stores, libraries, and other public
places, and airport security screening devices may affect stimulation. Additionally, RFID devices,
which are often used to read identification badges, as well as some tag deactivation devices, such
as those used at payment counters at stores and loan desks at libraries, may also affect
stimulation. Patients who are implanted with nonadjacent multiple leads and patients who are
sensitive to low stimulation thresholds may experience a momentary increase in their perceived
stimulation, which some patients have described as uncomfortable or jolting. Patients should
cautiously approach such devices and should request help to bypass them. If they must go
through a gate or doorway containing this type of device, patients should turn off their IPG and
proceed with caution, being sure to move through the device quickly.
Mobile phones.
The effect of mobile phones on neurostimulation system is unknown; patients
should avoid placing mobile phone directly over the system.
Adverse Effects
In addition to those risks commonly associated with surgery, the following risks are associated
with implanting or using this neurostimulation system:
 Unpleasant sensations or motor disturbances, including involuntary movement, cause by
stimulation at high outputs (if either occurs, turn off your IPG immediately.)
 Undesirable changes in stimulation, which may be related to cellular changes in tissue
around the electrodes, changes in electrode position, loose electrical connections, or lead
failure
 Pain where the needle has been inserted and below the level of implant,
 Persistent pain at the electrode site or over the implantable neurostimulator site
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