12
•
System damage
, which may require surgical replacement due to change in symptom control.
•
Operational changes to the Trial Stimulator
, causing it to turn on or off or to reset the settings, resulting in loss of stimulation
or return of symptoms. Re-programming 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.
Patient activities
Activities requiring twisting or stretching –
Patients should avoid activities that may strain the connections between the
implanted components of the Axonics SNM System and 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
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