WW029

One size only

The HFX iQ Kit is a device intended to provide stimulation therapy to the spinal cord through implanted leads. Indicated as aids 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. The Senza HFX iQ Kit when programmed to include a frequency of 10 kHz, is indicated as aid in the management of chronic intractable pain of the lower limbs, including unilateral or bilateral pain, associated with diabetic neuropathy. The Senza HFX iQ Kit when programmed to include a frequency of 10 kHz, is indicated as aids in the management of non surgical refractory back pain (intractable back pain without prior surgery and not a candidate for back surgery).

Count and link only, sourced from the TGA's Database of Recalls, Product Alerts and Product Corrections. "Market actions" includes recalls, product alerts and product corrections — full detail stays on the TGA's own site.