User's Manual

Safety Information

Precision Spectra™ System Information for Patients

90668560-01 Rev B 5 of 32

Since the majority of the patients were treated for FBSS, this article supports the use of SCS for the

treatment of FBSS.

In this study, one patient required a revision because of electrode fracture. One patient required

removal of the system due to local infection. One patient required replacement of the IPG due to

mechanical failure. Overall, 16 of 27 (59%) patients required a total of 36 repositioning procedures.

A retrospective analysis performed by Hassenbusch SJ et al. 1995 included patients with chronic

lower body pain, predominately neuropathic pain and pain either midline lower back and/or unilateral

or bilateral leg pain treated over a 5 year period. The study was a comparison of SCS to spinal

infusion of opioids. For patients with radicular pain involving one leg with or without unilateral buttock

pain, a trial of SCS was recommended ﬁ rst. For patients with midline back pain and /or bilateral leg

pain, a trial of long-term spinal infusion was recommended ﬁ rst. If the patients failed screening with

either of these modalities, the other was then tested. If the treatment reduced the pain by 50%, the

systems were internalized. A retrospective analysis of patients with unilateral leg and/or buttock pain

treated initially with SCS and bilateral leg or mainly low back pain treated initially with spinal infusions

of opioids was then done.

In this study, 42 patients were screened; 26 (62%) patients received spinal stimulation; 16 (38%)

received opioids via a spinal infusion pump. Five patients did not receive adequate pain relief

with SCS; 3 (7%) of these patients underwent trial spinal infusions and had effective pain relief.