Magnetic Resonance Imaging (Mri); Electromagnetic Interference (Emi); Case Damage; Effects On Other Implanted Devices - Axonics 1201 Mode D'emploi

through the implanted system, potentially causing tissue damage at the location of the implanted electrodes,
resulting in severe injury.

Magnetic Resonance Imaging (MRI)

The Axonics SNM System is an MRI Conditional system. Non-clinical testing has shown that MRI examinations of the
head can be safely conducted under specific conditions. Patients implanted with the Axonics SNM System should
not have full-body MRIs. Exposure to full body MRI scans may result in movement of the implanted components,
unintended stimulation through the lead, uncomfortable sensations or pain, and tissue damage. Refer to the
document"MRI Guidelines for the Axonics Sacral Neuromodulation System" for more information.

Electromagnetic interference (EMI)

Electromagnetic interference is energy generated by equipment found at home, work, or in public that can interfere
with the function of the Axonics SNM System. The Axonics SNM System includes features that provide protection
from EMI so that most electrical devices encountered in a normal day are unlikely to affect the operation of the
Neurostimulator. While everyday electrical devices are unlikely to affect the Neurostimulator, there are strong
sources of EMI that pose a higher risk, including theft detectors, security gates, and security wands. If patients
encounter any of these electrical devices, they should walk as far away from the sides of the device when passing
through. Additionally, patients should minimize their exposure to these devices by not lingering in the immediate
area of the device. Sources of strong EMI can result in the following:
• Serious patient injury, resulting from heating of the Neurostimulator and/or leads that causes damage to
surrounding tissue.
• System damage, which may require surgical replacement due to change in symptom control.
• Operational changes to the Neurostimulator, causing it to turn on or off or to reset the settings, resulting
in unexpected changes of stimulation and return of symptoms, causing a need for reprogramming by the
clinician.
• Unexpected changes in stimulation, leading to a sudden increase or change in stimulation, which may be
experienced as a jolting or shocking sensation.While the sensation may be uncomfortable, the device would not
be damaged nor would it cause direct injury to the patient. In rare cases, the change in stimulation may cause
the patient to fall and be injured.

Case Damage

The Neurostimulator contains battery chemicals that could cause severe burns if the Neurostimulator case were
ruptured or pierced.

Effects on other implanted devices

The effect of the Axonics SNM System on the operation of other implanted devices, such as cardiac devices, other
Neurostimulators, and implantable drug pumps, is not known. In particular, if the Axonics device is implanted
close to one of these devices, they may have sensing problems and/or inappropriate device responses. Potential
interference issues should be investigated before surgery by clinicians involved with both devices.The programming
of the devices may need to be optimized to provide maximum benefit from both devices.
Neurostimulator interaction with implanted cardiac devices - When a patient needs both an Axonics SNM
System and an implanted cardiac device (for example, a pacemaker or defibrillator), interactions between the
two devices should be discussed by the patients' physicians involved with both devices (such as the cardiologist,
electrophysiologist, urologist, and urogynecologist) before surgery. To reduce potential interference, the devices
should be implanted on opposite sides of the body and as far away from each other as practical.
• The stimulation pulses produced by the Axonics SNM System may interact with cardiac devices that sense
cardiac activity, leading to inappropriate behavior of the cardiac device.

PRECAUTIONS

Clinician programming

Parameter adjustment – The steps below should be taken to prevent sudden stimulation changes that lead to
an uncomfortable jolting or shocking feeling:
• Stimulation parameters should be changed in small increments.
• The stimulation amplitude should be allowed to ramp to full amplitude slowly.
• Before disconnecting the stimulation cable or turning the simulation on or off, the stimulation amplitude should
be decreased to 0.0 mA.
Sensitivity to stimulation – Some patients, especially those that are very sensitive to stimulation, may be able
to sense the telemetry signals associated with reprogramming.
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