Axonics 1601 Manual Del Usuario página 9

the TS. For example, movements that include bending, twisting, bouncing, or stretching may pull on the connection between the TS
and the lead(s). This may potentially cause movement of the lead or discomfort and may result in an unsuccessful trial period due
to lack of adequate stimulation of the sacral nerve. Clinicians should ask their patients about the activities in which they participate
and inform them of the need for restricting and minimizing activities during the trial stimulation period.
Component manipulation by patient (Twiddler's syndrome) –
Clinicians should advise patients to refrain from manipulating the components of the Axonics SNM System. Manipulation may cause
device damage, lead migration, skin erosion, or uncomfortable stimulation.
Scuba diving or hyperbaric chambers –
Patients should not scuba dive or use a hyperbaric chamber during their trial stimulation period.
Skydiving, skiing, or hiking in the mountains –
Patients should not sky-dive, ski or go hiking during the trial stimulation period.
Unexpected changes in stimulation –
EMI, postural changes, and other activities may cause a perceived increase in stimulation. Some patients may find this uncomfortable
(a jolting or shocking feeling). Before engaging in activities that receiving a jolt would be unsafe for the patient or those around
them, patients should lower the stimulation amplitude to the lowest setting and turn off the TS. Patients should also discuss these
activities with their clinician.
Showering and bathing during the trial stimulation period –
Patients should not expose the TS to water during the trial stimulation period. They may take sponge baths during the trial
stimulation period. However patients will have to remove the TS and keep their lead implant site and their surgical dressings dry.
Patients should be advised on avoiding showers and baths by their physician.
Patient programming and Remote Control
Patient access to Remote Control –
Patients should carry their Remote Control with them at all times. This will allow them to adjust the stimulation amplitude and/
or turn on/off the TS.
Remote Control may affect other implanted devices –
Patients should avoid placing the Remote Control over or near other active implanted medical devices (for example: pacemaker,
defibrillator and other neurostimulators).
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