Study: NCT02143791

Adverse event: Coronary artery disease
Serious: yes
Organ System: Cardiac disorders
Notes: Need to implant a stent, coronary artery disease
Frequency: 1 affected / 126 at risk

Adverse event: acute cardiac decompensation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 126 at risk

Adverse event: cardiac catherization
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 126 at risk

Adverse event: hypothyriodism
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 126 at risk

Adverse event: Diverticulum intestinal
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Laparascopic sigmoid resection due to diverticulosis
Frequency: 1 affected / 126 at risk

Adverse event: Abdominal pain upper
Serious: yes
Organ System: Gastrointestinal disorders
Notes: acute pancreatitis
Frequency: 1 affected / 126 at risk

Adverse event: Lead Breakage/Fracture
Serious: yes
Organ System: General disorders
Notes: lead breakage due to patients anatomical structure of the spine
Frequency: 1 affected / 126 at risk

Adverse event: Lead contacts mostly invalid
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 126 at risk

Adverse event: Lead dislodgement
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 126 at risk

Adverse event: Pain medication intolerance
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 126 at risk

Adverse event: Persistant pain and/or numbness IPG site only
Serious: yes
Organ System: General disorders
Notes: skinny patient, IPG sat uncomfortably in her abdominal region
Frequency: 1 affected / 126 at risk

Adverse event: Undesirable changes in paresthesia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 126 at risk

Adverse event: device uncomfortable
Serious: yes
Organ System: General disorders
Notes: device not implanted deep enough
Frequency: 1 affected / 126 at risk

Adverse event: opiate withdrawal
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 126 at risk

Adverse event: Ear infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 126 at risk

Adverse event: Infection: IPG & Lead site
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 126 at risk

Adverse event: Infection: IPG site only
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 126 at risk

Adverse event: Infection: Lead site only
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 126 at risk

Adverse event: Infection: extension site only
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 126 at risk

Adverse event: Cerebrospinal fluid leakage
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 126 at risk

Adverse event: Neoplasm malignant
Serious: yes
Organ System: Investigations
Notes: need MRI for diagnose cancer
Frequency: 1 affected / 126 at risk

Adverse event: Fall
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 126 at risk

Adverse event: ISG arthrose
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 126 at risk

Adverse event: Osteoarthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 126 at risk

Adverse event: Arthralgia
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 126 at risk

Adverse event: Persistant pain and/or numbness: undetermined
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 126 at risk

Adverse event: iliosacral joint osteoarthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 126 at risk

Adverse event: Pain in extremity
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 126 at risk

Adverse event: pain in vertrebral region due to fall
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 126 at risk

Adverse event: Bladder cancer diagnosed
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Bladder cancer diagnosed
Frequency: 1 affected / 126 at risk

Adverse event: Neoplasm malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 126 at risk

Adverse event: ataxic gait disturbance
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 126 at risk

Adverse event: IPG migration
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 126 at risk

Adverse event: Lead breakage/fracture
Serious: yes
Organ System: Product Issues
Frequency: 2 affected / 126 at risk

Adverse event: Lead dislodgement
Serious: yes
Organ System: Product Issues
Frequency: 3 affected / 126 at risk

Adverse event: Persistant pain and/or numbness: Lead site only
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 126 at risk

Adverse event: Undesirable changes in pain
Serious: yes
Organ System: Product Issues
Frequency: 2 affected / 126 at risk

Adverse event: bad connection IPG-extension
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 126 at risk

Adverse event: bad connection between lead and IPG
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 126 at risk

Adverse event: insufficient paresthesia coverage
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 126 at risk

Adverse event: Anxiety disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 126 at risk

Adverse event: Inability to control urination
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 126 at risk

Adverse event: ovarian abcess
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 126 at risk

Adverse event: Pain at IPG pocket
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: normal post implant fat necrosis over IPG
Frequency: 1 affected / 126 at risk

Adverse event: microcirculation disturbance right foot
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 126 at risk

Adverse event: peripheral artery disease
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 126 at risk

Adverse event: varicose vein surgery
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 126 at risk

Adverse event: Varicose vein
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 126 at risk

Adverse event: Diarrhea and vomitting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 126 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 126 at risk

Adverse event: Undesirable changes in pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 126 at risk

Adverse event: Opiate withdrawal
Serious: no
Organ System: General disorders
Frequency: 1 affected / 126 at risk

Adverse event: Undesirable changes in paraesthesia
Serious: no
Organ System: General disorders
Frequency: 3 affected / 126 at risk

Adverse event: Dental abcess
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 126 at risk

Adverse event: Infection: IPG site only
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 126 at risk

Adverse event: Infection: Lead site only
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 126 at risk

Adverse event: Respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 126 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 126 at risk

Adverse event: Fall
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 126 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 126 at risk

Adverse event: Joint effusion
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 126 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 126 at risk

Adverse event: Unintended stimulation effects: muscle spasms or cramping
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 126 at risk

Adverse event: Related to bladder carcinoma
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 126 at risk

Adverse event: Headaches- post procedure
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 126 at risk

Adverse event: High impedance
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 126 at risk

Adverse event: Lead breakage/fracture
Serious: no
Organ System: Product Issues
Frequency: 2 affected / 126 at risk

Adverse event: Lead extension retraction
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 126 at risk

Adverse event: Lead dislodgement
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 126 at risk

Adverse event: Persistent pain and/or numbness: undetermined
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 126 at risk

Adverse event: Undesirable changes in pain
Serious: no
Organ System: Product Issues
Frequency: 2 affected / 126 at risk

Adverse event: Undesirable changes in paraesthesia
Serious: no
Organ System: Product Issues
Frequency: 2 affected / 126 at risk

Adverse event: Undesirable changes in stimulation
Serious: no
Organ System: Product Issues
Frequency: 2 affected / 126 at risk

Adverse event: Burning sensation at IPG site
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 126 at risk

Adverse event: Subcutaneous tissue changes at implant site
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 126 at risk

Adverse event: Wound site complication
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 126 at risk