User's Manual

Information for Patients
Precision Spectra™ System Information for Patients
90668560-01 Rev B 8 of 32
Clinical Experience-Safety
Clinical data has been collected during a clinical study of the Precision System. As of January 15,
2004, 35 subjects were enrolled in the study at multiple sites and 26 subjects had a successful trial
stimulation 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
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.