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
the neurostimulation system is turned on or off.
Electrosurgery. To avoid harming the patient or damaging the neurostimulation system, do not
use monopolar electrosurgery devices on patients with implanted neurostimulation systems.
Before using an electrosurgery device, place the device in Surgery Mode using the patient
controller app or clinician programmer app. Confirm the neurostimulation system is functioning
correctly after the procedure.
During implant procedures, if electrosurgery devices must be used, take the following actions:
Use bipolar electrosurgery only.
Complete any electrosurgery procedures before connecting the leads or extensions to the
neurostimulator.
Keep the current paths from the electrosurgery device as far from the neurostimulation
system as possible.
Set the electrosurgery device to the lowest possible energy setting.
Confirm that the neurostimulation system is functioning correctly during the implant
procedure and before closing the neurostimulator pocket.
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.
Other active implanted devices. The neurostimulation system may interfere with the normal
operation of another active implanted device, such as a pacemaker, defibrillator, or another type
of neurostimulator. Conversely, the other active implanted device may interfere with the operation
of the neurostimulation system.
Interference with other devices. Some of this system’s electronic equipment, such as the
programmer and controller, can radiate radiofrequency (RF) energy that may interfere with other
electronic devices, including other active implanted devices. Avoid placing equipment
components directly over other electronic devices. To correct the effect of interference with other
devices, turn off the equipment or increase the distance between the equipment and the device
being affected.
Operation of machines, equipment, and vehicles. Patients using therapy that generates
paresthesia should turn off stimulation before operating motorized vehicles, such as automobiles,
or potentially dangerous machinery and equipment because sudden stimulation changes may
distract them from properly operating it. However, current data shows that most patients using
BurstDR™ stimulation therapy do not experience paresthesia. For patients who do not feel
paresthesia, sudden stimulation changes are less likely to occur and distract them while operating
motorized vehicles, machinery, or equipment.
