Long-term Safety of Spinal Cord Stimulation Systems in A Prospective, Global Registry of Patients With Chronic Pain

Figures & data

Figure 1. RELIEF study design schematic.

IPG: Implantable pulse generator; Mos.: Months.

Figure 2. Study subject disposition.

Table 1. Demographics for implanted^† subjects.

Demographics
Gender: n females (%) (n = 1286)	736 (57)
Age: mean (standard deviation) (n = 1286)	57.6 (13.7) years
Years since onset of pain: mean (standard deviation) (n = 1287)	11.6 (11.3) years
Diagnosis: n (%) [n = 1287 (some patients have multiple diagnoses)]	Radiculopathy: 681 (53)
	Failed back surgery syndrome: 652 (51)
	Complex regional pain syndrome: 79 (6)

† Demographic data missing for several implanted subjects.

Table 2. Device-related complications including explants up to 3 years (n = 1289 implanted participants).

Device-related complications up to 3 years follow-up	Total (incidence)
Explants (all)	98 (7.6%)
Explants due to inadequate pain relief	32 (2.5%)
Lead: high impedances	69 (5.4%)
Lead migration/movement	65 (5.0%)
Infection related to hardware or procedure (serious adverse event)	30 (2.3%)
IPG migration/movement	16 (1.2%)
IPG charging problems (not attributed to charger)	14 (1.1%)
Pain related to hardware, stimulation or procedure (serious adverse event)	12 (0.9%)
IPG: other	11 (0.9%)
Lead: other	6 (0.5%)

IPG: Implantable pulse generator.

Table 3. Serious adverse events (related to either device, procedure or stimulation), totaling 32 serious adverse events related to device and 51 events related to procedure (overlapping events may be reported) reported among the 1881 consenting patients.

Serious adverse events	Total number (events)	Events related to device	Events related to procedure	Events related to stimulation
Implant site pain	6	2	5	0
Device stimulation issue	1	1	1	1
Pain	1	0	1	0
Back pain	9	0	1	0
Extradural hematoma^†	4	0	1	0
Meningitis (bacterial)	1	0	1	0
Implant site abscess	1	0	1	0
Implant site effusion	1	1	1	1
Implant site reaction	1	1	0	0
Postoperative wound infection^‡	2	0	1	0
Medical device pain	1	1	0	1
Cellulitis	4	0	1	0
Pyrexia	1	0	1	0
Granuloma	1	1	1	0
Implant site infection	20	11	17	0
Wound infection	4	3	2	0
Device-related infection	4	3	4	0
Paraspinal abscess	1	1	0	0
Electric shock	1	1	0	0
Intracranial hypotension	1	0	1	0
Pain in extremity	4	1	0	0
Radicular pain	1	0	1	0
Bradycardia	4	1	2	0
Migraine	3	0	1	0
Sciatica	3	1	0	0
Muscular weakness	3	1	2	0
Pulmonary hypotension	1	0	1	0
Hypotension	2	1	1	0

† All events are epidural.

‡ One event from another surgery.

Data sharing statement

The data, analytic methods and study materials for this clinical study will be made available to other researchers in accordance with Boston Scientific Data Sharing Policy (https://www.bostonscientific.com).