Product Info

10001045 REV B 11
4 WARNINGS
WARNINGS. Statements about the use of the device that patients and doctors should take very seriously. If
patients and doctor do not follow these warnings, it is possible that the patient could be hurt, and / or the device
could be damaged.
4.1 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, effectiveness, or perception of paresthesia. Specifically, for
stimulation frequencies above 1,200 Hz, amplitudes that produce paresthesia have not been evaluated and
therefore it is unknown whether injury may occur.
PARESTHESIA. Tingling sensations caused by stimulation.
4.2 Stimulation at Vertebral Levels Above T8
The safety of program settings above 1,200 Hz have not been studied above the T8 vertebral level.
4.3 Patients Who Are Poor Surgical Candidates
The SCS system should not be implanted in a patient that is considered a poor surgical candidate. Implanting an
SCS system has risks similar to surgical procedures of the spine, including spinal fluid leak, headaches, swelling,
bruising, bleeding, infection, or paralysis.
4.4 Pregnancy and Nursing
The safety and effectiveness of spinal cord stimulation has not been established for use during pregnancy or
nursing.
4.5 Pediatric Use
The safety and effectiveness of spinal cord stimulation has not been established for pediatric use.
4.6 Other Active Implanted Devices
Patients must let their physicians know if they have any other active implanted devices. The Senza
®
Bluetooth
®
Trial System may interfere with other implanted stimulators, such as cardiac pacemakers and defibrillators which
have sensing features and may result in sensing problems or inappropriate responses. The effect of other
implanted devices, including deep brain stimulators, peripheral nerve stimulators, implanted drug delivery pumps,
and cochlear implants on the Senza
®
Bluetooth
®
Trial System is unknown.
4.7 Sleep