Trial Outcomes & Findings for Post-reimbursement Study to Follow Spinal Neurostimulator Devices for Pain Therapy (French SCS Registry) (NCT NCT01778426)

Last Updated: 2018-11-29

Results Overview

Percentage of primo-implanted subjects who responded to the treatment, where response was defined as a pain relief of at least 50% in the area with predominant pain intensity from baseline to two years follow-up. Pain intensity was assessed using an 11-point (0-10) Numeric Pain Rating Scale (NPRS) ranging from 0 (no pain) to 10 (maximum pain possible).

Recruitment status

COMPLETED

Target enrollment

414 participants

Primary outcome timeframe

2 years

Results posted on

2018-11-29

Participant Flow

The first subject enrolled in the study on January 13, 2012. The last subject was enrolled on December 19, 2013 and the last visit of the last subject was on January 11, 2016. A total of 414 patients were assessed for eligibility, across 28 sites in France, of which, 402 subjects were included in the final analysis.

Not applicable; this study was non-randomized in which no treatment group was assigned.

Participant milestones

Participant milestones
Measure	Primo-implant (PI) Subjects implanted for the first time with Medtronic SCS devices, in order to assess the effectiveness of the treatment compared to pre-operative situation.	Replacement (RP) Subjects implanted with a new Medtronic SCS neurostimulator as a replacement of their Medtronic SCS devices, in order to document the integrality of the practice and collect long-term data like complications and definitive explants.
Overall Study - Full Analysis Set (FAS) STARTED	264	138
Overall Study - Full Analysis Set (FAS) COMPLETED	208	113
Overall Study - Full Analysis Set (FAS) NOT COMPLETED	56	25
Intention-To-Treat (ITT) - Completer STARTED	198	0
Intention-To-Treat (ITT) - Completer COMPLETED	198	0
Intention-To-Treat (ITT) - Completer NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Post-reimbursement Study to Follow Spinal Neurostimulator Devices for Pain Therapy (French SCS Registry)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Primo-implant (PI) n=264 Participants Subjects implanted for the first time (primary implant group) with Medtronic SCS devices, in order to assess the effectiveness of the treatment compared to pre-operative situation.	Replacement (RP) n=138 Participants Subjects implanted with a new Medtronic SCS neurostimulator as a replacement of their Medtronic SCS devices (replacement group), in order to document the integrality of the practice and collect long-term data like complications and definitive explants.	Total n=402 Participants Total of all reporting groups
Age, Continuous	49.6 years STANDARD_DEVIATION 9.6 • n=5 Participants	56.5 years STANDARD_DEVIATION 11.4 • n=7 Participants	52.0 years STANDARD_DEVIATION 10.8 • n=5 Participants
Sex: Female, Male Female	117 Participants n=5 Participants	60 Participants n=7 Participants	177 Participants n=5 Participants
Sex: Female, Male Male	147 Participants n=5 Participants	78 Participants n=7 Participants	225 Participants n=5 Participants

PRIMARY outcome

Timeframe: 2 years

Population: ITT - completer (n=198) consists of all primo-implant subjects with baseline and follow-up pain intensity data at 2 years completed. Among 198 subjects, 179 patients had a visit at one year completed.

Outcome measures

Outcome measures
Measure	Primo-implant (PI) n=198 Participants Subjects implanted for the first time with Medtronic SCS devices	Primo-implant - 1 Year Subjects implanted for the first time with Medtronic SCS devices. Results at 1 year follow-up.	Primo-implant - 2 Years Subjects implanted for the first time with Medtronic SCS devices. Results at 2 years follow-up.
Percentage of Subjects With at Least 50% Pain Relief in the Area of Predominant Pain at 2 Years	59.1 Percentage of responders Interval 51.9 to 66.0	—	—

SECONDARY outcome

Timeframe: 1 year and 2 years

Percentage of primo-implanted subjects who responded to the treatment, where response was defined as a pain relief of at least 50% in the area with non-predominant pain intensity at 1 and 2 years follow-up, compared to baseline. Pain intensity was assessed using an 11-point (0-10) Numeric Pain Rating Scale (NPRS) ranging from 0 (no pain) to 10 (maximum pain possible).

Outcome measures

Outcome measures
Measure	Primo-implant (PI) n=198 Participants Subjects implanted for the first time with Medtronic SCS devices	Primo-implant - 1 Year Subjects implanted for the first time with Medtronic SCS devices. Results at 1 year follow-up.	Primo-implant - 2 Years Subjects implanted for the first time with Medtronic SCS devices. Results at 2 years follow-up.
Percentage of Subjects With at Least 50% Pain Relief in the Area of Non-predominant Pain 1 year	46.9 Percentage of responders Interval 38.3 to 55.5	—	—
Percentage of Subjects With at Least 50% Pain Relief in the Area of Non-predominant Pain 2 years	46.5 Percentage of responders Interval 38.3 to 54.7	—	—

SECONDARY outcome

Timeframe: 1 year

Percentage of primo-implanted subjects who responded to the treatment, where response was defined as a pain relief of at least 50% in the area with predominant pain intensity from baseline to one year follow-up. Pain intensity was assessed using an 11-point (0-10) Numeric Pain Rating Scale (NPRS) ranging from 0 (no pain) to 10 (maximum pain possible).

Outcome measures

Outcome measures
Measure	Primo-implant (PI) n=179 Participants Subjects implanted for the first time with Medtronic SCS devices	Primo-implant - 1 Year Subjects implanted for the first time with Medtronic SCS devices. Results at 1 year follow-up.	Primo-implant - 2 Years Subjects implanted for the first time with Medtronic SCS devices. Results at 2 years follow-up.
Percentage of Subjects With at Least 50% Pain Relief in the Area of Predominant Pain at 1 Year	60.7 Percentage of responders Interval 53.1 to 67.9	—	—

SECONDARY outcome

Timeframe: Baseline, 1 and 2 years

Percentage of primo-implanted subjects taking pain relief medication at baseline, 1 and 2 years.

Outcome measures

Outcome measures
Measure	Primo-implant (PI) n=198 Participants Subjects implanted for the first time with Medtronic SCS devices	Primo-implant - 1 Year n=179 Participants Subjects implanted for the first time with Medtronic SCS devices. Results at 1 year follow-up.	Primo-implant - 2 Years n=198 Participants Subjects implanted for the first time with Medtronic SCS devices. Results at 2 years follow-up.
Concomitant Pain Relief Medication Analgesic, level 1	59.1 Percentage of subject taking drug Interval 51.9 to 66.0	43.3 Percentage of subject taking drug Interval 35.9 to 50.9	43.9 Percentage of subject taking drug Interval 36.9 to 51.2
Concomitant Pain Relief Medication Analgesic, level 2	61.1 Percentage of subject taking drug Interval 53.9 to 67.9	35.4 Percentage of subject taking drug Interval 28.4 to 42.9	36.4 Percentage of subject taking drug Interval 29.7 to 43.5
Concomitant Pain Relief Medication Analgesic, level 3	44.9 Percentage of subject taking drug Interval 37.9 to 52.2	19.7 Percentage of subject taking drug Interval 14.1 to 26.3	18.7 Percentage of subject taking drug Interval 13.5 to 24.8
Concomitant Pain Relief Medication NSAID	28.8 Percentage of subject taking drug Interval 22.6 to 35.6	9.0 Percentage of subject taking drug Interval 5.2 to 14.2	8.6 Percentage of subject taking drug Interval 5.1 to 13.5
Concomitant Pain Relief Medication Antiepileptic	69.7 Percentage of subject taking drug Interval 62.8 to 76.0	38.2 Percentage of subject taking drug Interval 31.0 to 45.8	30.3 Percentage of subject taking drug Interval 24.0 to 37.2
Concomitant Pain Relief Medication Antidepressant	54.0 Percentage of subject taking drug Interval 46.8 to 61.1	33.7 Percentage of subject taking drug Interval 26.8 to 41.2	29.8 Percentage of subject taking drug Interval 23.5 to 36.7

SECONDARY outcome

Timeframe: Baseline, 1 and 2 years

Dose of analgesics level 3 (morphinics) summarized as equivalent morphine dose at baseline, 1 and 2 years.

Outcome measures

Outcome measures
Measure	Primo-implant (PI) n=89 Participants Subjects implanted for the first time with Medtronic SCS devices	Primo-implant - 1 Year n=35 Participants Subjects implanted for the first time with Medtronic SCS devices. Results at 1 year follow-up.	Primo-implant - 2 Years n=37 Participants Subjects implanted for the first time with Medtronic SCS devices. Results at 2 years follow-up.
Dose of Analgesics Level 3 (Morphinics)	90.2 Daily equivalent morphine dose in mg Standard Deviation 67.3	102.6 Daily equivalent morphine dose in mg Standard Deviation 95.8	100.3 Daily equivalent morphine dose in mg Standard Deviation 94.2

SECONDARY outcome

Timeframe: 1 and 2 years

Percentage of primo-implanted subjects satisfied with the treatment 1 and 2 years after implantation (defined as indicating "pain relief improvement," "daily life improvement," "rather satisfied with the treatment," or "would agree to the treatment again").

Outcome measures

Outcome measures
Measure	Primo-implant (PI) n=179 Participants Subjects implanted for the first time with Medtronic SCS devices	Primo-implant - 1 Year n=198 Participants Subjects implanted for the first time with Medtronic SCS devices. Results at 1 year follow-up.	Primo-implant - 2 Years Subjects implanted for the first time with Medtronic SCS devices. Results at 2 years follow-up.
Patient Satisfaction Pain relief improvement	89.9 Percentage of subjects satisfied Interval 84.5 to 93.9	89.3 Percentage of subjects satisfied Interval 84.2 to 93.3	—
Patient Satisfaction daily life activity improvement	82.0 Percentage of subjects satisfied Interval 75.6 to 87.4	81.8 Percentage of subjects satisfied Interval 75.7 to 86.9	—
Patient Satisfaction treatment satisfaction	89.9 Percentage of subjects satisfied Interval 84.5 to 93.9	91.4 Percentage of subjects satisfied Interval 86.6 to 94.9	—
Patient Satisfaction agree to the treatment again	92.1 Percentage of subjects satisfied Interval 87.2 to 95.6	92.9 Percentage of subjects satisfied Interval 88.4 to 96.1	—

SECONDARY outcome

Timeframe: 1 and 2 years

Percentage of subjects being invalid at inclusion and active at 1 and 2 years.

Outcome measures

Outcome measures
Measure	Primo-implant (PI) n=179 Participants Subjects implanted for the first time with Medtronic SCS devices	Primo-implant - 1 Year n=198 Participants Subjects implanted for the first time with Medtronic SCS devices. Results at 1 year follow-up.	Primo-implant - 2 Years Subjects implanted for the first time with Medtronic SCS devices. Results at 2 years follow-up.
Return to Work	8 Percentage of subjects	15 Percentage of subjects	—

Adverse Events

Full Analysis Set (FAS)

Serious events: 89 serious events

Other events: 105 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Full Analysis Set (FAS) n=402 participants at risk FAS includes all subjects from primo-implant (n=264) and replacement (n=138) groups enrolled in the study with a valid Patient Data Release Form. 402 subjects were analyzed in the FAS.
Infections and infestations Implant site infection	2.0% 8/402 • Adverse events were collected from enrollment through the study end. Adverse events related to the device or procedure (including definitive explant or repositioning) were collected. Whether an event met the criteria of serious was determined by the study site.
Infections and infestations Peritonitis	0.25% 1/402 • Adverse events were collected from enrollment through the study end. Adverse events related to the device or procedure (including definitive explant or repositioning) were collected. Whether an event met the criteria of serious was determined by the study site.
Psychiatric disorders Completed suicide	0.50% 2/402 • Adverse events were collected from enrollment through the study end. Adverse events related to the device or procedure (including definitive explant or repositioning) were collected. Whether an event met the criteria of serious was determined by the study site.
Nervous system disorders Allodynia	0.75% 3/402 • Adverse events were collected from enrollment through the study end. Adverse events related to the device or procedure (including definitive explant or repositioning) were collected. Whether an event met the criteria of serious was determined by the study site.
Nervous system disorders Intercostal neuralgia	0.25% 1/402 • Adverse events were collected from enrollment through the study end. Adverse events related to the device or procedure (including definitive explant or repositioning) were collected. Whether an event met the criteria of serious was determined by the study site.
Nervous system disorders Motor dysfunction	0.25% 1/402 • Adverse events were collected from enrollment through the study end. Adverse events related to the device or procedure (including definitive explant or repositioning) were collected. Whether an event met the criteria of serious was determined by the study site.
Nervous system disorders Neuralgia	1.00% 4/402 • Adverse events were collected from enrollment through the study end. Adverse events related to the device or procedure (including definitive explant or repositioning) were collected. Whether an event met the criteria of serious was determined by the study site.
Nervous system disorders Paraesthesia	0.25% 1/402 • Adverse events were collected from enrollment through the study end. Adverse events related to the device or procedure (including definitive explant or repositioning) were collected. Whether an event met the criteria of serious was determined by the study site.
Nervous system disorders Phantom pain	0.50% 2/402 • Adverse events were collected from enrollment through the study end. Adverse events related to the device or procedure (including definitive explant or repositioning) were collected. Whether an event met the criteria of serious was determined by the study site.
Cardiac disorders Myocardial infarction	0.25% 1/402 • Adverse events were collected from enrollment through the study end. Adverse events related to the device or procedure (including definitive explant or repositioning) were collected. Whether an event met the criteria of serious was determined by the study site.
Skin and subcutaneous tissue disorders Skin erosion	0.25% 1/402 • Adverse events were collected from enrollment through the study end. Adverse events related to the device or procedure (including definitive explant or repositioning) were collected. Whether an event met the criteria of serious was determined by the study site.
Musculoskeletal and connective tissue disorders Back pain	1.5% 6/402 • Adverse events were collected from enrollment through the study end. Adverse events related to the device or procedure (including definitive explant or repositioning) were collected. Whether an event met the criteria of serious was determined by the study site.
Musculoskeletal and connective tissue disorders Pain in extremity	0.25% 1/402 • Adverse events were collected from enrollment through the study end. Adverse events related to the device or procedure (including definitive explant or repositioning) were collected. Whether an event met the criteria of serious was determined by the study site.
Reproductive system and breast disorders Pelvic pain	0.25% 1/402 • Adverse events were collected from enrollment through the study end. Adverse events related to the device or procedure (including definitive explant or repositioning) were collected. Whether an event met the criteria of serious was determined by the study site.
General disorders Death	0.25% 1/402 • Adverse events were collected from enrollment through the study end. Adverse events related to the device or procedure (including definitive explant or repositioning) were collected. Whether an event met the criteria of serious was determined by the study site.
General disorders Device battery issue	1.00% 4/402 • Adverse events were collected from enrollment through the study end. Adverse events related to the device or procedure (including definitive explant or repositioning) were collected. Whether an event met the criteria of serious was determined by the study site.
General disorders Device dislocation	1.00% 4/402 • Adverse events were collected from enrollment through the study end. Adverse events related to the device or procedure (including definitive explant or repositioning) were collected. Whether an event met the criteria of serious was determined by the study site.
General disorders Device end of service	0.50% 2/402 • Adverse events were collected from enrollment through the study end. Adverse events related to the device or procedure (including definitive explant or repositioning) were collected. Whether an event met the criteria of serious was determined by the study site.
General disorders Device extension damage	0.25% 1/402 • Adverse events were collected from enrollment through the study end. Adverse events related to the device or procedure (including definitive explant or repositioning) were collected. Whether an event met the criteria of serious was determined by the study site.
General disorders Device issue	0.25% 1/402 • Adverse events were collected from enrollment through the study end. Adverse events related to the device or procedure (including definitive explant or repositioning) were collected. Whether an event met the criteria of serious was determined by the study site.
General disorders Device lead damage	0.25% 1/402 • Adverse events were collected from enrollment through the study end. Adverse events related to the device or procedure (including definitive explant or repositioning) were collected. Whether an event met the criteria of serious was determined by the study site.
General disorders Device lead issue	0.75% 3/402 • Adverse events were collected from enrollment through the study end. Adverse events related to the device or procedure (including definitive explant or repositioning) were collected. Whether an event met the criteria of serious was determined by the study site.
General disorders Device stimulation issue	1.7% 7/402 • Adverse events were collected from enrollment through the study end. Adverse events related to the device or procedure (including definitive explant or repositioning) were collected. Whether an event met the criteria of serious was determined by the study site.
General disorders Implant site hyperaesthesia	0.25% 1/402 • Adverse events were collected from enrollment through the study end. Adverse events related to the device or procedure (including definitive explant or repositioning) were collected. Whether an event met the criteria of serious was determined by the study site.
General disorders Implant site inflammation	0.25% 1/402 • Adverse events were collected from enrollment through the study end. Adverse events related to the device or procedure (including definitive explant or repositioning) were collected. Whether an event met the criteria of serious was determined by the study site.
General disorders Implant site pain	1.7% 7/402 • Adverse events were collected from enrollment through the study end. Adverse events related to the device or procedure (including definitive explant or repositioning) were collected. Whether an event met the criteria of serious was determined by the study site.
General disorders Medical device discomfort	0.25% 1/402 • Adverse events were collected from enrollment through the study end. Adverse events related to the device or procedure (including definitive explant or repositioning) were collected. Whether an event met the criteria of serious was determined by the study site.
General disorders Medical device site pain	0.50% 2/402 • Adverse events were collected from enrollment through the study end. Adverse events related to the device or procedure (including definitive explant or repositioning) were collected. Whether an event met the criteria of serious was determined by the study site.
General disorders Pain	7.5% 30/402 • Adverse events were collected from enrollment through the study end. Adverse events related to the device or procedure (including definitive explant or repositioning) were collected. Whether an event met the criteria of serious was determined by the study site.
Injury, poisoning and procedural complications Surgical skin tear	0.25% 1/402 • Adverse events were collected from enrollment through the study end. Adverse events related to the device or procedure (including definitive explant or repositioning) were collected. Whether an event met the criteria of serious was determined by the study site.
Injury, poisoning and procedural complications Wound complication	0.25% 1/402 • Adverse events were collected from enrollment through the study end. Adverse events related to the device or procedure (including definitive explant or repositioning) were collected. Whether an event met the criteria of serious was determined by the study site.
Surgical and medical procedures Medical device removal	0.25% 1/402 • Adverse events were collected from enrollment through the study end. Adverse events related to the device or procedure (including definitive explant or repositioning) were collected. Whether an event met the criteria of serious was determined by the study site.

Other adverse events

Other adverse events
Measure	Full Analysis Set (FAS) n=402 participants at risk FAS includes all subjects from primo-implant (n=264) and replacement (n=138) groups enrolled in the study with a valid Patient Data Release Form. 402 subjects were analyzed in the FAS.
Infections and infestations Implant site infection	1.7% 7/402 • Adverse events were collected from enrollment through the study end. Adverse events related to the device or procedure (including definitive explant or repositioning) were collected. Whether an event met the criteria of serious was determined by the study site.
Infections and infestations Infection	0.25% 1/402 • Adverse events were collected from enrollment through the study end. Adverse events related to the device or procedure (including definitive explant or repositioning) were collected. Whether an event met the criteria of serious was determined by the study site.
Immune system disorders Hypersensitivity	0.25% 1/402 • Adverse events were collected from enrollment through the study end. Adverse events related to the device or procedure (including definitive explant or repositioning) were collected. Whether an event met the criteria of serious was determined by the study site.
Psychiatric disorders Alcohol withdrawal syndrome	0.25% 1/402 • Adverse events were collected from enrollment through the study end. Adverse events related to the device or procedure (including definitive explant or repositioning) were collected. Whether an event met the criteria of serious was determined by the study site.
Psychiatric disorders Mental disorder	0.25% 1/402 • Adverse events were collected from enrollment through the study end. Adverse events related to the device or procedure (including definitive explant or repositioning) were collected. Whether an event met the criteria of serious was determined by the study site.
Nervous system disorders Burning sensation	0.50% 2/402 • Adverse events were collected from enrollment through the study end. Adverse events related to the device or procedure (including definitive explant or repositioning) were collected. Whether an event met the criteria of serious was determined by the study site.
Nervous system disorders Meningocele acquired	0.25% 1/402 • Adverse events were collected from enrollment through the study end. Adverse events related to the device or procedure (including definitive explant or repositioning) were collected. Whether an event met the criteria of serious was determined by the study site.
Nervous system disorders Neuralgia	0.25% 1/402 • Adverse events were collected from enrollment through the study end. Adverse events related to the device or procedure (including definitive explant or repositioning) were collected. Whether an event met the criteria of serious was determined by the study site.
Nervous system disorders Paraesthesia	1.7% 7/402 • Adverse events were collected from enrollment through the study end. Adverse events related to the device or procedure (including definitive explant or repositioning) were collected. Whether an event met the criteria of serious was determined by the study site.
Nervous system disorders Sciatica	0.50% 2/402 • Adverse events were collected from enrollment through the study end. Adverse events related to the device or procedure (including definitive explant or repositioning) were collected. Whether an event met the criteria of serious was determined by the study site.
Nervous system disorders Spinal claudication	0.25% 1/402 • Adverse events were collected from enrollment through the study end. Adverse events related to the device or procedure (including definitive explant or repositioning) were collected. Whether an event met the criteria of serious was determined by the study site.
Nervous system disorders Tension headache	0.25% 1/402 • Adverse events were collected from enrollment through the study end. Adverse events related to the device or procedure (including definitive explant or repositioning) were collected. Whether an event met the criteria of serious was determined by the study site.
Cardiac disorders Atrioventricular block complete	0.25% 1/402 • Adverse events were collected from enrollment through the study end. Adverse events related to the device or procedure (including definitive explant or repositioning) were collected. Whether an event met the criteria of serious was determined by the study site.
Vascular disorders Implant site haematoma	0.25% 1/402 • Adverse events were collected from enrollment through the study end. Adverse events related to the device or procedure (including definitive explant or repositioning) were collected. Whether an event met the criteria of serious was determined by the study site.
Vascular disorders Subcutaneous hematoma	0.25% 1/402 • Adverse events were collected from enrollment through the study end. Adverse events related to the device or procedure (including definitive explant or repositioning) were collected. Whether an event met the criteria of serious was determined by the study site.
Vascular disorders Syncope	0.25% 1/402 • Adverse events were collected from enrollment through the study end. Adverse events related to the device or procedure (including definitive explant or repositioning) were collected. Whether an event met the criteria of serious was determined by the study site.
Musculoskeletal and connective tissue disorders Arthralgia	0.25% 1/402 • Adverse events were collected from enrollment through the study end. Adverse events related to the device or procedure (including definitive explant or repositioning) were collected. Whether an event met the criteria of serious was determined by the study site.
Musculoskeletal and connective tissue disorders Back pain	0.75% 3/402 • Adverse events were collected from enrollment through the study end. Adverse events related to the device or procedure (including definitive explant or repositioning) were collected. Whether an event met the criteria of serious was determined by the study site.
Musculoskeletal and connective tissue disorders Flank pain	0.25% 1/402 • Adverse events were collected from enrollment through the study end. Adverse events related to the device or procedure (including definitive explant or repositioning) were collected. Whether an event met the criteria of serious was determined by the study site.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.25% 1/402 • Adverse events were collected from enrollment through the study end. Adverse events related to the device or procedure (including definitive explant or repositioning) were collected. Whether an event met the criteria of serious was determined by the study site.
Musculoskeletal and connective tissue disorders Pain in extremity	0.50% 2/402 • Adverse events were collected from enrollment through the study end. Adverse events related to the device or procedure (including definitive explant or repositioning) were collected. Whether an event met the criteria of serious was determined by the study site.
General disorders Device dislocation	2.0% 8/402 • Adverse events were collected from enrollment through the study end. Adverse events related to the device or procedure (including definitive explant or repositioning) were collected. Whether an event met the criteria of serious was determined by the study site.
General disorders Device ineffective	0.50% 2/402 • Adverse events were collected from enrollment through the study end. Adverse events related to the device or procedure (including definitive explant or repositioning) were collected. Whether an event met the criteria of serious was determined by the study site.
General disorders Device intolerance	0.25% 1/402 • Adverse events were collected from enrollment through the study end. Adverse events related to the device or procedure (including definitive explant or repositioning) were collected. Whether an event met the criteria of serious was determined by the study site.
General disorders Device stimulation issue	3.2% 13/402 • Adverse events were collected from enrollment through the study end. Adverse events related to the device or procedure (including definitive explant or repositioning) were collected. Whether an event met the criteria of serious was determined by the study site.
General disorders Implant site discolouration	0.25% 1/402 • Adverse events were collected from enrollment through the study end. Adverse events related to the device or procedure (including definitive explant or repositioning) were collected. Whether an event met the criteria of serious was determined by the study site.
General disorders Implant site hematoma	0.75% 3/402 • Adverse events were collected from enrollment through the study end. Adverse events related to the device or procedure (including definitive explant or repositioning) were collected. Whether an event met the criteria of serious was determined by the study site.
General disorders Implant site pain	5.2% 21/402 • Adverse events were collected from enrollment through the study end. Adverse events related to the device or procedure (including definitive explant or repositioning) were collected. Whether an event met the criteria of serious was determined by the study site.
General disorders Lead dislodgement	0.25% 1/402 • Adverse events were collected from enrollment through the study end. Adverse events related to the device or procedure (including definitive explant or repositioning) were collected. Whether an event met the criteria of serious was determined by the study site.
General disorders Medical device discomfort	1.00% 4/402 • Adverse events were collected from enrollment through the study end. Adverse events related to the device or procedure (including definitive explant or repositioning) were collected. Whether an event met the criteria of serious was determined by the study site.
General disorders Necrosis	0.25% 1/402 • Adverse events were collected from enrollment through the study end. Adverse events related to the device or procedure (including definitive explant or repositioning) were collected. Whether an event met the criteria of serious was determined by the study site.
General disorders Pain	7.2% 29/402 • Adverse events were collected from enrollment through the study end. Adverse events related to the device or procedure (including definitive explant or repositioning) were collected. Whether an event met the criteria of serious was determined by the study site.
General disorders Therapeutic product ineffective	0.25% 1/402 • Adverse events were collected from enrollment through the study end. Adverse events related to the device or procedure (including definitive explant or repositioning) were collected. Whether an event met the criteria of serious was determined by the study site.
Injury, poisoning and procedural complications Fall	0.25% 1/402 • Adverse events were collected from enrollment through the study end. Adverse events related to the device or procedure (including definitive explant or repositioning) were collected. Whether an event met the criteria of serious was determined by the study site.
Injury, poisoning and procedural complications Procedural complication	0.25% 1/402 • Adverse events were collected from enrollment through the study end. Adverse events related to the device or procedure (including definitive explant or repositioning) were collected. Whether an event met the criteria of serious was determined by the study site.
Injury, poisoning and procedural complications Procedural pain	0.75% 3/402 • Adverse events were collected from enrollment through the study end. Adverse events related to the device or procedure (including definitive explant or repositioning) were collected. Whether an event met the criteria of serious was determined by the study site.
Surgical and medical procedures Neurostimulator removal	0.25% 1/402 • Adverse events were collected from enrollment through the study end. Adverse events related to the device or procedure (including definitive explant or repositioning) were collected. Whether an event met the criteria of serious was determined by the study site.

Additional Information

Neuromodulation, Clinical Study Management

Medtronic

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee It is stated in the CIP and Agreement signed by the investigators that the French SCS Registry data are the sole property of Medtronic.
Publication restrictions are in place

Restriction type: OTHER