Safety Information

Important Safety Information

10 kHz and other available SCS frequencies and waveforms are delivered by Senza Spinal Cord Stimulation (SCS) systems.1 Throughout this website all referenced SCS system components including the Implantable Pulse Generator (IPG), Leads, and Accessories are a part of the Senza System.

When is the Senza System used?

The Senza®, Senza II™ and Senza Omnia™ neuromodulation systems are used as aids in the management of chronic intractable pain of the trunk and/or limbs. This includes pain associated with failed back surgery syndrome, intractable low back pain, and leg pain.

The Senza®, Senza II™ and Senza Omnia™ neuromodulation systems, when programmed to include a frequency of 10 kHz, are indicated as aids in the management of chronic intractable pain of the lower limbs, including unilateral or bilateral pain, associated with diabetic neuropathy.

When should it not be used?

The Senza System may not be appropriate for certain patients, including patients who:

  1. did not receive effective pain relief during a trial stimulation phase;
  2. because of concurrent medical conditions are poor candidates for the planned surgical procedure; and/or
  3. are not able to operate the Senza System.

Side effects or risks involved with the Senza System:

The Senza System has a similar safety profile to other SCS systems and the side effects or risks associated with use of this or any other SCS systems that have been available for many years are similar. Some patients may be at higher risk of surgical complications, including those with diabetes. Discuss with your physician to assess all the risks involved.

You will first go through a trial phase where you and your doctor evaluate the therapy to see if its right for you. During the trial of the Senza System, a thin flexible wire (stimulator lead) is typically placed through a needle into the epidural space within the spinal column. Uncommon risks from this include bleeding, infection, pain at insertion site, headache from cerebrospinal fluid leak and the very rare potential for neurological damage. At the time of implant, the lead is again inserted or alternatively the surgeon may choose to place a flat “paddle” style lead directly into the epidural space with similar risks.

If the Senza System is right for you, your doctor will discuss with you the implantation of the Senza System. During the implant procedure, the surgeon will place the stimulating generator (similar to a pacemaker) underneath the skin in a suitable location. As with other minor surgical procedures complications include anesthetic risks, infection, poor wound healing and pain at the surgical site. Most complications are mild or temporary, but in extremely rare cases can cause serious injury or death.

It’s also possible you may experience complications after the device is implanted, including loss of pain relief, lead migration, allergy and pain/uncomfortable stimulation due to lead migration. These complications may result in reprogramming the device, medical treatment, corrective surgery or removal of the device.

When operating a Senza System in low frequency modes (i.e., 1,200 Hz or less), the system will typically be programmed to produce a mild paresthesia (i.e., a sensation commonly experienced as tingling, buzzing or numbness). Changes in posture or abrupt movements may cause decreases, or uncomfortable or painful increases, in the perceived stimulation level. You can turn the stimulation down or off before making posture changes. If unpleasant sensations occur, the stimulation should be turned off immediately. Do not operate any automobile, other motorized vehicle or dangerous equipment while low frequency stimulation is switched on as sudden stimulation changes, if they occur, may distract you from attentive operation of the vehicle or equipment.

FOLLOW INSTRUCTIONS FOR USE AT ALL TIMES. Please see the Patient Manual for important safety information and detailed MRI information. Also, please discuss the benefits and risks of any procedure with your doctor.

All patients do not respond to spinal cord stimulation in the same way and results may vary.

1 Senza SCS systems are approved to provide 10 kHz therapy in the United States, European Union, and Australia. The use of Senza SCS systems to additionally provide all available frequencies and multiple waveforms is currently only approved in the United States.