Safety Information

Important Safety Information
HF10 is delivered by the Senza Spinal Cord Stimulation system. Throughout this website all referenced devices including the Implant, Leads, and Patient Accessories are a part of the Senza System.

When is the Senza System used?
The Senza System is used as an aid in the management of chronic intractable pain of the trunk and/or limbs. This includes one-sided or two-sided pain associated with failed back surgery syndrome, intractable low back pain, and leg pain. FOLLOW THE INSTRUCTIONS FOR USE IF SYMPTOMS PERSIST SEE YOUR DOCTOR/HEALTHCARE PROFESSIONAL.

When should it not be used?

  1. In patients who have not received effective pain relief during a trial stimulation or are poor surgical candidates.
  2. With shortwave, microwave and/or therapeutic ultrasound diathermy.

Side effects or risks involved with the Senza System:
The Senza System has a very similar safety profile to other SCS devices that have been available for many years.

The implant is surgically placed under the skin, so surgical complications are possible. As with other similar surgeries, complications may include infection, pain at the site of surgery, bleeding and in extremely rare cases paralysis or death.

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

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.

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I am answering these questions for:

Myself A relative or friend

HF10 is FDA approved in the United States for the treatment of chronic intractable pain of the trunk and/or limbs. Only a physician can recommend a specific treatment option.

How long have you been suffering from pain?

Less than 6 months 6 to 12 months More than 12 months

Where is your pain located?

(Select all that apply)

Patient Assessment Body
Next

On average, rate your pain level over the past 30 days:

No Pain

0 1 2 3 4 5 6 7 8 9 10

Worst Pain Imaginable

No Pain

Worst Pain Imaginable

Which treatments have you already tried?

(Select all that apply)

Next

What does your pain stop you from doing?

(Select all that apply)

Next

Please select your gender.

Male Female

What statement describes you best?

I'm exploring my treatment options before I find a pain specialist I'm exploring my treatment options with a pain specialist My doctor has recommended a spinal cord stimulator and I am considering trying a temporary system I am scheduled to try a temporary spinal cord stimulator I am scheduled to receive an implanted spinal cord stimulator I currently have a spinal cord stimulator implated

Thank you for sharing your experience.

Unfortunately, chronic pain is complex and it is unclear if you are an appropriate candidate for HF10 spinal cord stimulation at this time. Only a physician can recommend a specific treatment, we suggest you continue this discussion with your physician.

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Your pain condition appears similar to other patients being treated with HF10.

Get your results and a discussion guide to share with your doctor.

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