Boston Scientific Neuromodulation Corporation PSC5210W Manual Do Utilizador
Introduction
7
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 2 weeks to
6 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 2 weeks to
6 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.
Skin Erosion
0
0%
0%
Lead Breakage
35
3.3%
4.0%
Hardware Malfunction
22
2.1%
2.5%
Loose Connection
0
0%
0%
Battery Failure
2
0.2%
0.2%
Other
45
4.3%
5.1%
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