User Guide

Patient Trial Handbook 38 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
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.
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