Introduction; Axonics Snm Therapy For Urinary Control; Indications; Precautions - Axonics 1201 Mode D'emploi

INTRODUCTION

This manual provides information about the Axonics Sacral Neuromodulation (SNM) System tined lead and the lead
implantation procedure. The tined lead can be used with the Axonics Model 1101 Neurostimulator.
The tined lead connects to a stimulation device, which creates a series of electrical pulses to stimulate the sacral nerve.
A set of accessories, including procedure-specific surgical tools, Axonics Model 1801, and stimulation cables, and a
Clinician Programmer (CP), Axonics Model 1501 are used to implant the tined lead.
Instructions for connections to the Neurostimulator are found in the Neurostimulator manual.

AXONICS SNM THERAPY FOR URINARY CONTROL

Indications

Axonics SNM therapy for urinary control is indicated for the treatment of urinary retention and the symptoms of
overactive bladder, including urinary urge incontinence and significant symptoms of urgency-frequency alone or in
combination, in patients who have failed or could not tolerate more conservative treatments.
Warning: This therapy is not intended for patients with mechanical obstruction such as benign prostatic
hypertrophy, cancer, or urethral stricture.

Precautions

Clinician training

Implanting clinicians should be trained on the implantation and use of the Axonics SNM System.
Prescribing clinicians should be experienced in the diagnosis and treatment of lower urinary tract symptoms and
should be trained on the use of the Axonics SNM System.

Use in specific populations

The safety and effectiveness of this therapy has not been established for:
• Pregnant women
• Pediatric use (patients under the age of 16)
• Patients with neurological disease origins, such as multiple sclerosis or diabetes
• Bilateral stimulation.

AXONICS SNM THERAPY FOR BOWEL CONTROL

Indications
Axonics SNM therapy for bowel control is indicated for the treatment of chronic fecal incontinence in patients who
have failed or are not candidates for more conservative treatments.
Precautions
Clinician training
Implanting clinicians should be trained on the implantation and use of the Axonics SNM System.
Prescribing clinicians should be experienced in the diagnosis and treatment of fecal incontinence and should be
trained on the use of the Axonics SNM System.
Use in specific populations
The safety and effectiveness of this therapy has not been established for:
• Pregnant women
• Pediatric use (patients under the age of 18)
• Patients with progressive, systemic neurological diseases
• Bilateral stimulation.

CONTRAINDICATIONS

The Axonics SNM System is contraindicated for patients who are unable to operate the Axonics SNM System.

WARNINGS

Diathermy

Shortwave diathermy, microwave diathermy, or therapeutic ultrasound diathermy (collectively described as
diathermy) should not be used on patients implanted with the Axonics SNM System. Diathermy can transmit energy
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