User's Manual

Information for Patients
Precision Spectra™ System Information for Patients
90668560-01 Rev B 6 of 32
There were 4 (10%) patients who underwent a trial of spinal infusion of opioid but did not receive
adequate pain relief; these patients were not tested with SCS. Pain severity was rated using a
verbal digital pain scale: “On a scale of 0 to 10 where 0 is no pain and 10 is the worst pain you could
ever imagine, what is your pain now?” 16/26 patients (62%) had greater than 50% pain relief with
SCS. In this study, 2/16 (13%) had greater than 50% pain relief with opioids. Mean follow-up was
2.1 ± 0.3 years. This analysis supports the use of SCS for intractable low back and leg pain.
In this study, 7 (17%) patients suffered complications after implantation of the device; 5 (12%)
patients required repositioning of catheter type electrodes and 2 patients required revision of the
stimulator generator.
Safety Evaluation
Eleven studies were identifi ed based on the detailed inclusion/exclusion criteria to demonstrate
the safety of the Precision Spectra™ System. The studies included a total of 1056 patients that
were trialed with SCS systems and 880 patients that received implants. The table below depicts
the number of patients, the number of events, and the percentage of occurrences of each event
compared to the total number of patients. It should be noted that citations cover both IPG and
RF Systems. The clinical experience reported in the literature on RF systems is relevant to
determining the safety of totally implantable IPG systems.