Adverse Events; Patient Counseling Information; Component Disposal - Axonics 1201 Mode D'emploi

ADVERSE EVENTS

Implantation and use of the Axonics SNM System incurs risk beyond those normally associated with surgery, some of
which may necessitate surgical intervention. These risks include, but are not limited to the following:
• Adverse change in voiding function (bowel and/or bladder)
• Allergic or immune system response to the implanted materials that could result in device rejections
• Change in sensation or magnitude of stimulation which has been described as uncomfortable (jolting or
shocking) by some patients
• Infection
• Pain or irritation at Neurostimulator and/or lead site
• Seroma, hemorrhage, and/or hematoma
• Suspected lead or Neurostimulator migration or erosion
• Suspected nerve injury (including numbness)
• Suspected technical device malfunctions
• Transient electric shock or tingling
• Unintended nerve activation
• Heating or burn at Neurostimulator site

PATIENT COUNSELING INFORMATION

Clinicians should provide the following:
• Information about the components of the Axonics SNM System.
• Instructions for using the Remote Control and Charge System.
Also, the clinician should provide each patient with a copy of the Axonics SNM System Patient Therapy Guide and, in
particular, review the following sections with him/her:
• Getting the Axonics SNM System
• Living with the Axonics SNM System
Clinicians should also instruct their patients as follows:
• Patients should tell their healthcare professionals, including their primary doctor and dentist, that they have an
implanted neuromodulation system. Patients should bring their Patient Therapy Guide to all medical and dental
appointments in the event that their healthcare profession has any questions regarding any precautions to take
to avoid potential device problems.
• Patients should always carry their Remote Control to allow them to change the stimulation amplitude and/or
turn the Neurostimulator on or off.
• Patients should always bring their Remote Control to appointments related to their Axonics SNM system,
including all programming sessions.
• Patients should contact their physician if they have any unusual signs or symptoms.

COMPONENT DISPOSAL

The following steps should be taken when the Axonics SNM System is explanted (for example, due to replacement,
cessation of therapy, or after patient death) or when disposing of accessories:
• If possible, the explanted component should be returned to Axonics along with completed paperwork for
analysis and disposal.
• The device should not be autoclaved or exposed to ultrasonic cleaners to allow it to be analyzed by Axonics.
• Any components not returned to Axonics should be disposed of according to local regulations. Any potentially
contaminated materials should be treated as biohazardous waste.
Note that in some countries, explanting a battery-operated implantable device is mandatory.
Cautions:
• Components that are explanted or that have come into contact with bodily fluids should be handled with
appropriate biohazard controls. Such components should only be returned to Axonics in packaging supplied by
Axonics.
• The Neurostimulator may explode if subjected to high temperatures; therefore the Neurostimulator should not
be incinerated and should be explanted before patient cremation.
• Implantable devices should not be reused after exposure to body tissues or fluids because the sterility and
functionality of these devices cannot be assured.
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