Boston Scientific Neuromodulation Corporation PSC5110W Manual De Usuario
6
Physician Lead Manual
patients with unilateral leg and/or buttock pain treated initially with
SCS and bilateral leg or mainly low back pain treated initially with
spinal infusions of opioids was then done.
SCS and bilateral leg or mainly low back pain treated initially with
spinal infusions of opioids was then done.
In this study, 42 patients were screened; 26 (62%) patients received
spinal stimulation; 16 (38%) received opioids via a spinal infusion
pump. Five patients did not receive adequate pain relief with SCS; 3
(7%) of these patients underwent trial spinal infusions and had effec-
tive pain relief. 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.
spinal stimulation; 16 (38%) received opioids via a spinal infusion
pump. Five patients did not receive adequate pain relief with SCS; 3
(7%) of these patients underwent trial spinal infusions and had effec-
tive pain relief. 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 implanta-
tion of the device; 5 (12%) patients required repositioning of catheter
type electrodes and 2 patients required revision of the stimulator gen-
erator.
tion of the device; 5 (12%) patients required repositioning of catheter
type electrodes and 2 patients required revision of the stimulator gen-
erator.
Safety Evaluation
Eleven studies were identified based on the detailed inclusion/exclu-
sion criteria to demonstrate the safety of the PRECISION 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 percent-
age of occurrences of each event compared to the total number of
patients. It should be noted that citations cover both IPG and RF Sys-
tems. The clinical experience reported in the literature on RF systems
is relevant to determining the safety of totally implantable IPG sys-
tems.
Eleven studies were identified based on the detailed inclusion/exclu-
sion criteria to demonstrate the safety of the PRECISION 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 percent-
age of occurrences of each event compared to the total number of
patients. It should be noted that citations cover both IPG and RF Sys-
tems. The clinical experience reported in the literature on RF systems
is relevant to determining the safety of totally implantable IPG sys-
tems.