Boston Scientific Precision Novi Guia De Informacion página 8

Information for Prescribers
If any of the above is required by medical necessity, refer to "Instructions for the Physician" on
page 7. Ultimately, however, the device may require explantation as a result of damage to
the device.
Automobiles and Other Equipment. Patients should not operate automobiles, other
motorized vehicles, or potentially dangerous machinery/ equipment with therapeutic stimulation
switched on. Stimulation must be turned off first. Sudden stimulation changes, if they occur,
may distract patients from attentive operation of the vehicle or equipment.
Post Operative. During the two weeks following surgery, it is important that patients use
extreme care so that appropriate healing will secure the implanted components and close the
surgical incisions:
• Patients should not lift objects of more than five pounds.
• Patients should not engage in rigorous physical activity such as twisting, bending, or climbing.
• If new leads were implanted, patients should not raise their arms above their head.
Temporarily, there may be some pain in the area of the implant as the incisions heal. Patients
should be instructed that if discomfort continues beyond two weeks, they should contact their
physician.
If patients notice excessive redness around the wound areas during this time, they should
contact their physician to check for infection and administer proper treatment. In rare cases,
adverse tissue reaction to implanted materials can occur during this period.
Patients should consult their physician before making lifestyle changes due to decreases in pain.
Stimulator Location. Patients should never attempt to change the orientation or "flip" (rotate
or spin) the Stimulator. Patients should not "finger" or play with the Stimulator. If the Patient
knows that the device has turned, the Patient should contact his or her physician to arrange an
evaluation of the system. In some cases, the skin over the Stimulator may become very thin
over time. If this occurs, Patients should contact their physicians.
Lead Location. In some instances, a lead can move from its original location, and stimulation
at the intended pain site can be lost. If this occurs, Patients should consult their physician who
may able to restore stimulation by reprogramming the Stimulator in the clinic or repositioning
the lead during another operation.
Device Failure. Stimulators can fail at any time due to random component failure, loss of
battery functionality, or lead breakage. If the device stops working, Patients should turn off the
Stimulator and contact their physician so that the system can be evaluated.
Operating Temperature. The operating temperature of the Remote Control and Programming
Wand is 10–40 °C (50–104 °F).
Precision Novi™ System Information for Prescribers
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