Boston Scientific Neuromodulation Corporation PSC5110W Manual De Usuario
8
Physician Lead Manual
Clinical Experience-Safety
Clinical data has been collected during a clinical study of the PRECI-
SION™ System. As of January 15, 2004, 35 subjects were enrolled in
the study at multiple sites and 26 subjects had a successful trial stimu-
lation period and were implanted with the PRECISION™ System.
The follow-up period for the 26 implanted patients ranged from two
weeks to six months. The following major adverse events were
reported.
Clinical data has been collected during a clinical study of the PRECI-
SION™ System. As of January 15, 2004, 35 subjects were enrolled in
the study at multiple sites and 26 subjects had a successful trial stimu-
lation period and were implanted with the PRECISION™ System.
The follow-up period for the 26 implanted patients ranged from two
weeks to six months. The following major adverse events were
reported.
Table 2: Clinical Experience Safety
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 malfunc-
tion. Two of the subjects reported multiple events.
receiver malfunction, skin irritation, unpleasant stimulation, CSF
leak, infection at implant site, lead migration, and OR cable malfunc-
tion. 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.
“Prospective, Multicenter Study of Spinal Cord Stimulation for
Relief of Chronic Back and Extremity Pain.” Spine, 21:2786-
2793, 1996.
Type
Number of Patients
Resolution
Lead Migration
1
Lead repositioning
and subsequent
replacement
and subsequent
replacement
Output malfunction
1
Device replaced
Infection 1
Infection
treated
Pain 1
Lead
explanted