Introduction; Purpose Of The Trial System; Contraindications; Warnings - Axonics 1901 PNE Lead Manual Del Usario

INTRODUCTION

This manual provides information about the Axonics Sacral Neuromodulation (SNM) System PNE lead (Model 1901) and
its implantation procedure. The peripheral nerve evaluation (PNE) lead is used in a basic trial with the Axonics Model
1601, external Trial Stimulator (TS). The TS is used to provide temporary electrical stimulation to the S3 or S4 sacral
nerve, and this stimulation with the PNE lead is intended to not exceed 7 days.
The PNE lead connects to the Basic Trial Cable (Axonics Model 1701). This cable is then connected to the TS. The TS
creates a series of electrical pulses to stimulate the sacral nerve. A set of accessories is used to implant the PNE lead.
This includes procedure-specific surgical tools and stimulation cables (Axonics Model 1701) and a Clinician Programmer
(CP) (Axonics Model 2501).
Instructions for connections to the TS are found in the TS manual.

PURPOSE OF THE TRIAL SYSTEM

The Axonics SNM Trial System is used for a test period to evaluate if a subject should be treated with the Axonics SNM System.

CONTRAINDICATIONS

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

WARNINGS

Diathermy
Do not use shortwave diathermy, microwave diathermy, or therapeutic ultrasound diathermy (collectively described as
diathermy) on patients implanted with the Axonics SNM System. Diathermy can transmit energy through the implanted
system, potentially causing tissue damage at the location of the implanted electrodes. This could result in severe injury.
Magnetic Resonance Imaging (MRI)
An MRI should not be conducted on an individual undergoing a trial period of SNM therapy utilizing the external TS.
The following additional medical procedures that may affect the Axonics SNM System should be avoided during the
trial period:
• Lithotripsy
• Monopolar electro surgery
• Microwave and Radio-frequency (RF) ablation
• Radiation therapy
• Ultrasound or scanning equipment

Electromagnetic interference (EMI)

EMI is energy that can interfere with the function of the Axonics SNM System. This energy can be generated by
equipment found at home, work, or in public. The Axonics SNM System includes features that provide protection from
EMI. Most electrical devices encountered in a normal day are unlikely to affect the operation of the TS. While everyday
electrical devices are unlikely to affect the TS, there are strong sources of EMI that pose a higher risk. These include theft
detectors, security gates, and security wands. If patients encounter any of these electrical devices, they should walk
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 TS and/or leads. This may damage the surrounding tissue.
• System damage, which may require surgical replacement due to change in symptom control.
• Operational changes to the TS, causing it to turn on or off or to reset the settings. This will result in loss of
stimulation or return of symptoms. Reprogramming by the clinician may be needed.
• Unexpected changes 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 TS contains battery chemicals that could cause severe burns if the case were ruptured or pierced.
Effects on other implanted devices
The effect of the Axonics SNM System on the operation of other implanted devices is not known. This includes devices
such as cardiac devices, other Neurostimulators, and implantable drug pumps. In particular, if the Axonics device is on
the body near one of these devices, they may have sensing problems and/or inappropriate device responses. Clinicians
involved with both devices should investigate potential interference issues before surgery. The programming of the
devices may need to be optimized to provide maximum benefit from both devices.
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