User's Manual

Precision Spectra System Clinical Summary
Precision Spectra™ System Information for Prescribers
90668515-01 Rev A 5 of 15
Table 2: Clinical Experience Safety
Type Number of Patients Resolution
Lead Migration 1 Lead repositioning and subsequent
replacement
Output malfunction 1 Device replaced
Infection 1 Infection treated
Pain 1 Lead explanted
Other minor adverse events reported by at least one patient included: receiver malfunction, skin
irritation, unpleasant stimulation, CSF leak, infection at implant site, lead migration, and OR
cable malfunction. Two of the subjects reported multiple events.
References
Burchiel, K.J., V.C. Anderson, F.D. Brown, R.G. Fessler, W.A. Friedman, S. Pelofsky, R.L.
Weiner, J. Oakley,and D. Shatin. “Prospective, Multicenter Study of Spinal Cord
Stimulation for Relief of Chronic Back and Extremity Pain.”Spine, 21:2786-2793, 1996.
Hassenbusch, S.J., M. Stanton-Hicks, E.C. Covington. “Spinal cord stimulation verses spinal
infusion for low back andleg pain”. Acta Neurochirgica, 64:109-115, 1995.
Kemler, M.A., G.A.M. Barendse, M. Van Kleef, H.C.W. De Vet, C.P.M. Rijks, C.A. Furnee and
F.A.J.M. Van den Wilderberg. “Spinal Cord Stimulation in Patients with Chronic Refl ex
Sympathetic Dystrophy.” New England J of Medicine, 343: 618-24, 2000.
Kim S. H., R.R. Tasker, and M.Y. Oh. “Spinal Cord Stimulation for Nonspecifi c Limb Pain versus
Neuropathic Pain and Spontaneous versus Evoked Pain.” Neurosurgery, 48(5):
1056-1064, 2001.
Kumar, K., C. Toth, R. Nath, and P. Lang. “Epidural Spinal Cord Stimulation for Treatment of
Chronic Pain-Some Predictors of Success. A 15 year experience.” Surg Neurol,
50: 110-120, 1998.
Lang, P. “The Treatment of Chronic Pain by Epidural Spinal Cord Stimulation.” AXON, 18(4):
71-73, 1997.
Ohnmeiss, D., R. Rashbaum, M. Bogdanffy. Prospective Outcome Evaluation of Spinal Cord
Stimulation in Patients With Intractable Leg Pain. Spine, 21:1344-1351, 1996.