Safety

Important Safety Information

Patient experiences with the HFX iQ™ or Senza Omnia™ spinal cord stimulation (SCS) system vary by individual, including the amount of pain relief. The occurrence of adverse effects associated with SCS implant surgery or use also varies by patient.

Indications for Use: The HFX iQ, Senza Omnia, and HFX Trial spinal cord stimulation systems 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. These 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 and the management of non-surgical refractory back pain (intractable back pain without prior surgery and not a candidate for back surgery).

Contraindications: These include patients who are poor SCS surgical candidates, are unable to operate the SCS system and fail to receive effective pain relief during trial stimulation.

Warnings: Safety and effectiveness has not been established for pediatric use or in pregnancy. Interference with other implanted stimulators, such as cardiac pacemakers and defibrillators which have sensing features and may result in sensing problems or inappropriate responses. Sources of electromagnetic interference (theft detectors, security screening devices, power lines, RF equipment, mobile phones, radio systems, electrostatic discharge etc.) may interact with the system, resulting in unexpected changes in stimulation, serious patient injury and system damage. Energy from diathermy can be transferred through the implanted system and can cause tissue damage, resulting in severe injury or death. Senza implantable stimulators are MR conditional and scanning under different conditions may result in severe patient injury or device malfunction. Use of certain medical devices or procedures (electrocautery, radiation therapy, ultrasonic scanning) may result in device damage. Induced electrical currents from radiofrequency (RF) or microwave ablation may cause heating, resulting in tissue damage.

Precautions: Avoid activities that put stress on the implanted spinal cord stimulation system components. Safety has not been established for Transcranial Magnetic Stimulation (TMS) or Electroconvulsive Therapy (ECT) in patients who have an implanted SCS system. Patients experiencing persistent discomfort or excessive redness around the wound areas may need to be checked for infection by their physician.

Adverse Events: May include hematoma, epidural hemorrhage, paralysis, pain at implant site, infection and other surgical risks. Device related adverse events may include loss of pain relief or paresthesia, undesirable change in stimulation (uncomfortable, jolting or shocking sensation), tissue reaction or allergy to implanted materials.