Abbott Eterna 32400, Clinician Manual

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. If use of

electrocautery is necessary, place the neurostimulator in Surgery mode using the clinician programmer app

or the patient controller app before using an electrosurgery device.
During the implant procedure, if an electrosurgery device must be used, take the following actions:

▪

Use bipolar electrosurgery only.

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▪

Place the neurostimulator in Surgery mode before using an electrosurgery device.

▪
▪

Set the electrosurgery device to the lowest possible energy setting. Output power below 80 W is

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recommended for all activations.

▪

Complete any electrosurgery before connecting the leads or extensions to the neurostimulator.

▪
▪

Keep the current paths from the electrosurgery device as far from the neurostimulation system as

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possible.

▪

Exit Surgery mode during intraoperative testing and after the procedure is completed.

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NOTE: During intraoperative testing, Surgery mode must be turned off for the neurostimulation system

to function correctly.

▪

Confirm that the neurostimulation system is functioning correctly during the implant procedure, before

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closing the neurostimulator pocket, and after the implant procedure.

After any surgery, check the neurostimulation system for the following:

▪

Check the neurostimulator to ensure Surgery mode has been turned off, even if Surgery mode was not

▪

turned on at the beginning or during the procedure.

▪

Confirm the neurostimulation system is functioning.

▪

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; (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.

Explosive and flammable gases.

 Do not use a clinician programmer or patient controller around explosive or

flammable gas fumes or vapors. This includes oxygen-enriched environments such as hyperbaric chambers.

Operating the device near gas fumes or vapors could cause them to catch fire. If gas fumes or vapors catch

fire, it could cause severe burns, injury, or death.

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