Patient Counseling Information; Device Description - Axonics 1601 Manual Del Usuario

• Change in sensation or magnitude of stimulation which has been described as uncomfortable (jolting or shocking) by some patients
• Infection
• Suspected lead migration
• Suspected nerve injury (including numbness)
• Suspected technical device malfunction
• Transient electric shock or tingling
• Unintended nerve activation

PATIENT COUNSELING INFORMATION

Clinicians should provide the following:
• Information about the components of the Axonics SNM System
• Instructions for using the Remote Control
Also, the clinician should provide each patient with a copy of the Axonics SNM System Patient Therapy Guide. The clinician should
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 a trial SNM system.
Patients should bring their Patient Therapy Guide to all medical and dental appointments. This will help resolve any questions
that their healthcare professional may have regarding any precautions to take to avoid potential device problems.
• Patients should always carry their Remote Control. This allows patients to change the stimulation amplitude and/or turn the TS
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

DEVICE DESCRIPTION

The Axonics TS (Figure 1) is part of the Axonics SNM System. The TS is a programmable device that is worn on the outside of the body.
The TS delivers electrical stimulation to the sacral nerve via connections to either a permanent or temporary lead.
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