Nevro Senza - INDICATIONS; WARNINGS

INDICATIONS
The Senza system is not right for everyone. Indications for the use of this device are as
follows:
The Senza neuromodulation system is indicated as an aid in the management of
chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain
associated with the following: failed back surgery syndrome, intractable low back
pain, and leg pain.
INDICATIONS. Reasons that you should get a device, drug, or treatment. Indications
are determined by medical experts, clinical studies, and the Food & Drug
Administration (FDA).
CONTRAINDICATIONS
CONTRAINDICATIONS. Situations in which the device should not be used because the
risk of use clearly outweighs any possible benefit. Contraindications are determined
by medical experts, clinical studies, and the Food & Drug Administration (FDA).
The Senza system is contraindicated (not appropriate) for certain patients.
Contraindications for the Senza system include:
• Not being able to operate the Senza system
• Not being able to have the SCS surgery
• Failing to receive effective pain relief during trial stimulation.
Your doctor can tell you if the Senza system might be appropriate for you. If you have
questions about whether the Senza system may be right for you, ask your doctor.
WARNINGS
Warnings are statements about safety of your device that you should take very
seriously. If you do not follow these warnings, it is possible that you could be hurt
and/or the device could be damaged. The following are some warnings for the Senza
system:
Stimulation Frequencies
– Stimulation frequencies in the range of 2 Hz to 1,200 Hz are
indicated for paresthesia-based therapy and the system must be configured to
produce paresthesia. Stimulation at 10,000 Hz is indicated as paresthesia-free therapy
and the system must be configured to deliver paresthesia-free stimulation.
Stimulation between 1,200 Hz and 10,000 Hz has not been evaluated for safety,
Patient Manual 11052 Rev A (2015-01-16) 8