Study: NCT01778426

Adverse event: Implant site infection
Serious: yes
Organ System: Infections and infestations
Frequency: 8 affected / 402 at risk

Adverse event: Peritonitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 402 at risk

Adverse event: Completed suicide
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 402 at risk

Adverse event: Allodynia
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 402 at risk

Adverse event: Intercostal neuralgia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 402 at risk

Adverse event: Motor dysfunction
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 402 at risk

Adverse event: Neuralgia
Serious: yes
Organ System: Nervous system disorders
Frequency: 4 affected / 402 at risk

Adverse event: Paraesthesia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 402 at risk

Adverse event: Phantom limb syndrome
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 402 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 402 at risk

Adverse event: Skin erosion
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 402 at risk

Adverse event: Back pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 402 at risk

Adverse event: Pain in extremity
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 402 at risk

Adverse event: Pelvic pain
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 402 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 402 at risk

Adverse event: Device power source issue
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 402 at risk

Adverse event: Device dislocation
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 402 at risk

Adverse event: Device end of service
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 402 at risk

Adverse event: Device extension damage
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 402 at risk

Adverse event: Device issue
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 402 at risk

Adverse event: Device lead damage
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 402 at risk

Adverse event: Device lead issue
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 402 at risk

Adverse event: Device stimulation issue
Serious: yes
Organ System: General disorders
Frequency: 7 affected / 402 at risk

Adverse event: Implant site hyperaesthesia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 402 at risk

Adverse event: Implant site inflammation
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 402 at risk

Adverse event: Implant site pain
Serious: yes
Organ System: General disorders
Frequency: 7 affected / 402 at risk

Adverse event: Medical device discomfort
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 402 at risk

Adverse event: Medical device site pain
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 402 at risk

Adverse event: Pain
Serious: yes
Organ System: General disorders
Frequency: 30 affected / 402 at risk

Adverse event: Surgical skin tear
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 402 at risk

Adverse event: Wound complication
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 402 at risk

Adverse event: Medical device removal
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 402 at risk

Adverse event: Implant site infection
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 402 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 402 at risk

Adverse event: Hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 402 at risk

Adverse event: Alcohol withdrawal syndrome
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 402 at risk

Adverse event: Mental disorder
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 402 at risk

Adverse event: Burning sensation
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 402 at risk

Adverse event: Meningocele acquired
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 402 at risk

Adverse event: Neuralgia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 402 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 402 at risk

Adverse event: Sciatica
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 402 at risk

Adverse event: Spinal claudication
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 402 at risk

Adverse event: Tension headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 402 at risk

Adverse event: Atrioventricular block complete
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 402 at risk

Adverse event: Implant site haematoma
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 402 at risk

Adverse event: Subcutaneous haematoma
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 402 at risk

Adverse event: Syncope
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 402 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 402 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 402 at risk

Adverse event: Flank pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 402 at risk

Adverse event: Intervertebral disc protrusion
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 402 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 402 at risk

Adverse event: Device dislocation
Serious: no
Organ System: General disorders
Frequency: 8 affected / 402 at risk

Adverse event: Device ineffective
Serious: no
Organ System: General disorders
Frequency: 2 affected / 402 at risk

Adverse event: Device intolerance
Serious: no
Organ System: General disorders
Frequency: 1 affected / 402 at risk

Adverse event: Device stimulation issue
Serious: no
Organ System: General disorders
Frequency: 13 affected / 402 at risk

Adverse event: Implant site discolouration
Serious: no
Organ System: General disorders
Frequency: 1 affected / 402 at risk

Adverse event: Implant site haematoma
Serious: no
Organ System: General disorders
Frequency: 3 affected / 402 at risk

Adverse event: Implant site pain
Serious: no
Organ System: General disorders
Frequency: 21 affected / 402 at risk

Adverse event: Lead dislodgement
Serious: no
Organ System: General disorders
Frequency: 1 affected / 402 at risk

Adverse event: Medical device discomfort
Serious: no
Organ System: General disorders
Frequency: 4 affected / 402 at risk

Adverse event: Necrosis
Serious: no
Organ System: General disorders
Frequency: 1 affected / 402 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 29 affected / 402 at risk

Adverse event: Product ineffective
Serious: no
Organ System: General disorders
Frequency: 1 affected / 402 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 402 at risk

Adverse event: Procedural complication
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 402 at risk

Adverse event: Procedural pain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 402 at risk

Adverse event: Neurostimulator removal
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 402 at risk