Study: NCT00589797

Adverse event: Blood cholesterol increased
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 218 at risk

Adverse event: Cardiac Issues
Serious: yes
Organ System: Cardiac disorders
Notes: Includes arrhythmia, chest pain, heart disease and myocardial infarct
Frequency: 5 affected / 218 at risk

Adverse event: Eyes, Ears, Nose or Throat Issues
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 218 at risk

Adverse event: Diabetes mellitus
Serious: yes
Organ System: Endocrine disorders
Frequency: 4 affected / 218 at risk

Adverse event: Goitre
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 218 at risk

Adverse event: Esophageal Issues
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Includes esophageal bleeding and esophagitis
Frequency: 1 affected / 218 at risk

Adverse event: Gastric Issues
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Includes abdominal pain, stomach flu, gastric infection and peptic ulcer
Frequency: 3 affected / 218 at risk

Adverse event: Intestinal Issues
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Includes appendicitis and bowel obstruction
Frequency: 5 affected / 218 at risk

Adverse event: Other GI Issues
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Includes weight gain, colonoscopy and hernia repair
Frequency: 4 affected / 218 at risk

Adverse event: Gall Bladder Issues
Serious: yes
Organ System: Hepatobiliary disorders
Notes: Includes cholecystectomy, cholecystitis and gallstones
Frequency: 4 affected / 218 at risk

Adverse event: Liver Fibrosis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 218 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 218 at risk

Adverse event: Hypersensitivity
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 218 at risk

Adverse event: Systemic infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 218 at risk

Adverse event: Injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Includes motor vehicle accident, fall, trip, slip or twist
Frequency: 3 affected / 218 at risk

Adverse event: Bone Fracture - Non-Lumbar
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 218 at risk

Adverse event: Degenerative Joint Disease - Lumbar
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Includes arthritis, facet joint degeneration and rheumatoid arthritis
Frequency: 6 affected / 218 at risk

Adverse event: Degenerative Joint Disease - Non-Lumbar
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Includes inflammatory polyarthritis
Frequency: 1 affected / 218 at risk

Adverse event: Joint or Muscle Issues
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Includes ganglion cyst, hallux rigidus, hip-joint pain, surgery, torn meniscus and trigger finger
Frequency: 10 affected / 218 at risk

Adverse event: Muscle spasms
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 218 at risk

Adverse event: Non-Lumbar Radiographic Observation
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Includes disc bulge and disc herniation
Frequency: 2 affected / 218 at risk

Adverse event: Pain in Non-Lumbar or Leg
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Includes neck and thoracic
Frequency: 3 affected / 218 at risk

Adverse event: Neoplasm malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Includes breast, colon, prostate, rectal, skin and vulvar
Frequency: 11 affected / 218 at risk

Adverse event: Lower Extremity Pain
Serious: yes
Organ System: Nervous system disorders
Notes: Includes bilateral lower leg, unilateral upper and lower leg
Frequency: 7 affected / 218 at risk

Adverse event: Lumbar Only Pain
Serious: yes
Organ System: Nervous system disorders
Frequency: 6 affected / 218 at risk

Adverse event: Lumbar and Lower Extremeties Sensory Deficit
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 218 at risk

Adverse event: Lumbar and Lower Extremities Motor Deficit
Serious: yes
Organ System: Nervous system disorders
Notes: Includes general and transient unilateral motor deficit
Frequency: 2 affected / 218 at risk

Adverse event: Lumbar and Lower Extremity Pain
Serious: yes
Organ System: Nervous system disorders
Notes: Includes lumbar + unilateral and bilateral radiation into upper and lower leg
Frequency: 9 affected / 218 at risk

Adverse event: Non-Lumbar and Lower Extremities Deficit
Serious: yes
Organ System: Nervous system disorders
Notes: Includes brain tumor, headache, loss of consciousness, nerve entrapment, seizure, vertigo and carpal tunnel syndrome
Frequency: 3 affected / 218 at risk

Adverse event: Pregnancy Related Issues
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Includes pregnancy, delivery and miscarriages
Frequency: 7 affected / 218 at risk

Adverse event: Psychosocial Disorders
Serious: yes
Organ System: Psychiatric disorders
Notes: Includes conversion disorder, depression and suicidal attempt
Frequency: 1 affected / 218 at risk

Adverse event: Substance Related Disorders
Serious: yes
Organ System: Psychiatric disorders
Notes: Includes substance dependence and withdrawal
Frequency: 4 affected / 218 at risk

Adverse event: Completed suicide
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 218 at risk

Adverse event: Benign prostatic hyperplasia
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 218 at risk

Adverse event: Kidney Issues
Serious: yes
Organ System: Renal and urinary disorders
Notes: Includes kidney stones
Frequency: 2 affected / 218 at risk

Adverse event: Female Reproductive System Issues
Serious: yes
Organ System: Reproductive system and breast disorders
Notes: Includes breast implant leakage, irregular menstrual bleeding and ovarian or uterine cyst or mass or tumor
Frequency: 3 affected / 218 at risk

Adverse event: Male Reproductive System Issues
Serious: yes
Organ System: Reproductive system and breast disorders
Notes: Includes erectile dysfunction and retrograde ejaculation
Frequency: 5 affected / 218 at risk

Adverse event: Reproductive System Related Surgeries
Serious: yes
Organ System: Reproductive system and breast disorders
Notes: Includes breast reduction or enhancement and hysterectomy
Frequency: 3 affected / 218 at risk

Adverse event: Respiratory Infections
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Includes bronchitis and pneumonia
Frequency: 2 affected / 218 at risk

Adverse event: Device Deficiency
Serious: yes
Organ System: Surgical and medical procedures
Notes: Includes implant expulsion, malposition, migration and subsidence
Frequency: 7 affected / 218 at risk

Adverse event: Index Procedure Related Wounds
Serious: yes
Organ System: Surgical and medical procedures
Notes: Includes deep wounds, dural injuries and incisional hernia
Frequency: 4 affected / 218 at risk

Adverse event: Blood Loss
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 218 at risk

Adverse event: Blood pressure measurement
Serious: yes
Organ System: Vascular disorders
Notes: Includes syncope
Frequency: 1 affected / 218 at risk

Adverse event: Embolism
Serious: yes
Organ System: Vascular disorders
Notes: Includes pulmonary embolism
Frequency: 1 affected / 218 at risk

Adverse event: Thrombosis
Serious: yes
Organ System: Vascular disorders
Notes: Includes deep vein thrombosis
Frequency: 2 affected / 218 at risk

Adverse event: Vascular Issues
Serious: yes
Organ System: Vascular disorders
Notes: Includes aneurysm, atherosclerosis and iliac vessel tear
Frequency: 1 affected / 218 at risk

Adverse event: Blood pressure measurement
Serious: no
Organ System: Vascular disorders
Notes: Includes hypertension and syncope
Frequency: 9 affected / 218 at risk

Adverse event: Vascular Issues
Serious: no
Organ System: Vascular disorders
Notes: Includes aneurysm, arterial dissection, atherosclerosis and iliac vessel tear
Frequency: 4 affected / 218 at risk

Adverse event: Cardiac Issues
Serious: no
Organ System: Cardiac disorders
Notes: Includes arrhythmia, chest pain, heart disease and myocardial infarct
Frequency: 4 affected / 218 at risk

Adverse event: Diabetes mellitus
Serious: no
Organ System: Endocrine disorders
Frequency: 4 affected / 218 at risk

Adverse event: Eyes, Ears, Nose or Throat
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 6 affected / 218 at risk

Adverse event: Gastric Issues
Serious: no
Organ System: Gastrointestinal disorders
Notes: Includes abdominal adhesion, abdominal pain, acid reflux, indigestion, food poisoning, GERD, gastric lesions, gastritis, stomach flu, gastrointestinal infection and peptic ulcer
Frequency: 27 affected / 218 at risk

Adverse event: Intestinal Issues
Serious: no
Organ System: Gastrointestinal disorders
Notes: Includes bowel irregularity, constipation, diverticulitis, GI bleed, inflammatory bowel syndrome, nausea, vomiting and diarrhea
Frequency: 16 affected / 218 at risk

Adverse event: Pregnancy Related Issues
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Includes pregnancy and delivery
Frequency: 2 affected / 218 at risk

Adverse event: Male Reproductive System Issues
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Includes epididymitis, erectile dysfunction, inguinal or testicular pain, rectocele and retrograde ejaculation
Frequency: 7 affected / 218 at risk

Adverse event: Female Reproductive System Issues
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Includes abnormal PAP smear results, breast, ovarian or uterine cyst, mass or tumor, cystocele, menopause, vaginal or yeast infection
Frequency: 6 affected / 218 at risk

Adverse event: Reproductive System Related Surgeries
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Includes abortion, hysterectomy and lumpectomy
Frequency: 4 affected / 218 at risk

Adverse event: Urinary Issues
Serious: no
Organ System: Renal and urinary disorders
Notes: Includes decreased urine output, bladder infection, hematuria, incontinence, dysuria, pelvic pain, urinary hesitance, retention, urgency or tract infection
Frequency: 23 affected / 218 at risk

Adverse event: Non-Procedure Allergic Reactions
Serious: no
Organ System: Immune system disorders
Notes: Includes seasonal and systemic allergic reactions
Frequency: 3 affected / 218 at risk

Adverse event: Infections
Serious: no
Organ System: Infections and infestations
Notes: Includes abscess, cellulitis and non-procedure wound infections
Frequency: 4 affected / 218 at risk

Adverse event: Blood cholesterol increased
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 218 at risk

Adverse event: Degenerative Joint Disease - Lumbar
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Includes ankylosing spondylitis, arthritis, arthropathy and facet joint degeneration
Frequency: 4 affected / 218 at risk

Adverse event: Plantar Fascitis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 218 at risk

Adverse event: Joint or Muscle Issues
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Includes non-lumbar benign mass or tumor, bursitis, ganglion cyst, gout, hallux rigidus, hiccups, hip joint pain, non-lumbar joint sprain, leg length discrepancy, SI joint pain, surgery, torn meniscus, torn hip labral tear and trigger finger
Frequency: 19 affected / 218 at risk

Adverse event: Pain in Non-Lumbar or Leg
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Includes ankle, back, upper extremities, neck and thoracic, fibromyalgia, and foot
Frequency: 45 affected / 218 at risk

Adverse event: Non-Lumbar Radiographic Observation
Serious: no
Organ System: Surgical and medical procedures
Notes: Includes disc bulge, protrusion and herniation
Frequency: 19 affected / 218 at risk

Adverse event: Lumbar and Lower Extremity Motor Deficit
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Includes general, persistent and transient unilateral and bilateral motor deficit
Frequency: 6 affected / 218 at risk

Adverse event: Lumbar and Lower Extremity Sensory Deficit
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Includes unilateral and bilateral general and upper extremity sensory deficit, positive or change in SLR test
Frequency: 24 affected / 218 at risk

Adverse event: Reflex Change or Abnormality
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 218 at risk

Adverse event: Non-Lumbar and Lower Extremity Deficit
Serious: no
Organ System: Nervous system disorders
Notes: Includes Bell's palsy, brain tumor, dysphagia, memory loss, headache, loss of consciousness, migraine, nerve entrapment, numbness, restlessness, seizure, tremor, vertigo, carpal tunnel, peripheral neuropathy, upper extremity motor/sensory deficits
Frequency: 18 affected / 218 at risk

Adverse event: Lower Extremity Pain
Serious: no
Organ System: Nervous system disorders
Notes: Includes unilateral and bilateral upper and lower leg
Frequency: 40 affected / 218 at risk

Adverse event: Lumbar Only Pain
Serious: no
Organ System: Nervous system disorders
Frequency: 44 affected / 218 at risk

Adverse event: Lumbar and Lower Extremity Pain
Serious: no
Organ System: Nervous system disorders
Notes: Includes lumbar + unilateral and bilateral radiation into upper and lower leg
Frequency: 42 affected / 218 at risk

Adverse event: Psychosocial Disorders
Serious: no
Organ System: Psychiatric disorders
Notes: Includes anxiety, bipolar and depressive disorders
Frequency: 12 affected / 218 at risk

Adverse event: Substance Related Disorders
Serious: no
Organ System: Psychiatric disorders
Notes: Includes substance dependence or withdrawal
Frequency: 6 affected / 218 at risk

Adverse event: Sleep Disorders
Serious: no
Organ System: Psychiatric disorders
Notes: Includes fatigue, sleepiness, somnolence and insomnia
Frequency: 6 affected / 218 at risk

Adverse event: Breathing Disorders
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Includes dyspnea, sleep apnea, cough and asthma
Frequency: 6 affected / 218 at risk

Adverse event: Respiratory Infections
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Includes bronchitis, respiratory and sinus infection
Frequency: 10 affected / 218 at risk

Adverse event: Other Respiratory Disorders
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Includes COPD, hemoptysis, pleuritic chest pain, reactive airway disease
Frequency: 4 affected / 218 at risk

Adverse event: Injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Includes motor vehicle accident, fall, trip, slip or twist
Frequency: 38 affected / 218 at risk

Adverse event: Index Procedure Related Wounds
Serious: no
Organ System: Surgical and medical procedures
Notes: Includes abscess, deep wound, dehiscence, dural injuries, erythema, drainage, inflammation, incisional hernia, incisional cellulitis, pain at incision site, suture reaction and wound infection
Frequency: 17 affected / 218 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 106 at risk

Adverse event: Eyes, Ears, Nose or Throat Issues
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 106 at risk

Adverse event: Diabetes mellitus
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 106 at risk

Adverse event: Esophageal Issues
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Includes esophageal bleeding and esophagitis
Frequency: 1 affected / 106 at risk

Adverse event: Gastric Issues
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Includes abdominal pain, stomach flu, gastric infection and peptic ulcer
Frequency: 2 affected / 106 at risk

Adverse event: Intestinal Issues
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Includes appendicitis and bowel obstruction
Frequency: 5 affected / 106 at risk

Adverse event: Gall Bladder Issues
Serious: yes
Organ System: Hepatobiliary disorders
Notes: Includes cholecystectomy, cholecystitis and gallstones
Frequency: 3 affected / 106 at risk

Adverse event: Sjogren's syndrome
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 106 at risk

Adverse event: Hypersensitivity
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 106 at risk

Adverse event: Systemic infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 106 at risk

Adverse event: Injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Includes motor vehicle accident, fall, trip, slip or twist
Frequency: 1 affected / 106 at risk

Adverse event: Bone Fracture - Lumbar
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 106 at risk

Adverse event: Non-Lumbar Radiographic Observation
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Includes disc bulge and disc herniation
Frequency: 6 affected / 106 at risk

Adverse event: Pain in Non-Lumbar or Leg
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Includes neck and thoracic
Frequency: 4 affected / 106 at risk

Adverse event: Plantar Fascitis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 106 at risk

Adverse event: Neoplasm malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Includes breast, colon, prostate, rectal, skin and vulvar
Frequency: 5 affected / 106 at risk

Adverse event: Lower Extremity Pain
Serious: yes
Organ System: Nervous system disorders
Notes: Includes bilateral lower leg, unilateral upper and lower leg
Frequency: 4 affected / 106 at risk

Adverse event: Lumbar Only Pain
Serious: yes
Organ System: Nervous system disorders
Frequency: 6 affected / 106 at risk

Adverse event: Lumbar and Lower Extremity Pain
Serious: yes
Organ System: Nervous system disorders
Notes: Includes lumbar + unilateral and bilateral radiation into upper and lower leg
Frequency: 8 affected / 106 at risk

Adverse event: Non-Lumbar and Lower Extremities Deficit
Serious: yes
Organ System: Nervous system disorders
Notes: Includes brain tumor, headache, loss of consciousness, nerve entrapment, seizure, vertigo and carpal tunnel syndrome
Frequency: 4 affected / 106 at risk

Adverse event: Pregnancy Related Issues
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Includes pregnancy, delivery and miscarriages
Frequency: 1 affected / 106 at risk

Adverse event: Psychosocial Disorders
Serious: yes
Organ System: Psychiatric disorders
Notes: Includes conversion disorder, depression and suicidal attempt
Frequency: 3 affected / 106 at risk

Adverse event: Substance Related Disorders
Serious: yes
Organ System: Psychiatric disorders
Notes: Includes substance dependence and withdrawal
Frequency: 2 affected / 106 at risk

Adverse event: Kidney Issues
Serious: yes
Organ System: Renal and urinary disorders
Notes: Includes kidney stones
Frequency: 1 affected / 106 at risk

Adverse event: Female Reproductive System Issues
Serious: yes
Organ System: Reproductive system and breast disorders
Notes: Includes breast implant leakage, irregular menstrual bleeding and ovarian or uterine cyst or mass or tumor
Frequency: 2 affected / 106 at risk

Adverse event: Male Reproductive System Issues
Serious: yes
Organ System: Reproductive system and breast disorders
Notes: Includes erectile dysfunction and retrograde ejaculation
Frequency: 4 affected / 106 at risk

Adverse event: Reproductive System Related Surgeries
Serious: yes
Organ System: Reproductive system and breast disorders
Notes: Includes breast reduction or enhancement and hysterectomy
Frequency: 1 affected / 106 at risk

Adverse event: Breathing Disorders
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Includes dyspnea
Frequency: 1 affected / 106 at risk

Adverse event: Respiratory Infections
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Includes bronchitis and pneumonia
Frequency: 3 affected / 106 at risk

Adverse event: Device Deficiency
Serious: yes
Organ System: Surgical and medical procedures
Notes: Includes implant expulsion, malposition, migration and subsidence
Frequency: 3 affected / 106 at risk

Adverse event: Index Procedure Related Wounds
Serious: yes
Organ System: Surgical and medical procedures
Notes: Includes deep wounds, dural injuries and incisional hernia
Frequency: 2 affected / 106 at risk

Adverse event: Subsequent Surgical Intervention Procedure Related Wounds
Serious: yes
Organ System: Surgical and medical procedures
Notes: Includes incisional hernia
Frequency: 1 affected / 106 at risk

Adverse event: Blood pressure measurement
Serious: yes
Organ System: Vascular disorders
Notes: Includes syncope
Frequency: 2 affected / 106 at risk

Adverse event: Vascular Issues
Serious: yes
Organ System: Vascular disorders
Notes: Includes aneurysm, atherosclerosis and iliac vessel tear
Frequency: 3 affected / 106 at risk

Adverse event: Blood pressure measurement
Serious: no
Organ System: Vascular disorders
Notes: Includes hypertension and syncope
Frequency: 7 affected / 106 at risk

Adverse event: Vascular Issues
Serious: no
Organ System: Vascular disorders
Notes: Includes aneurysm, arterial dissection, atherosclerosis and iliac vessel tear
Frequency: 1 affected / 106 at risk

Adverse event: Cardiac Issues
Serious: no
Organ System: Cardiac disorders
Notes: Includes arrhythmia, chest pain, heart disease and myocardial infarct
Frequency: 3 affected / 106 at risk

Adverse event: Eyes, Ears, Nose or Throat
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 6 affected / 106 at risk

Adverse event: Gastric Issues
Serious: no
Organ System: Gastrointestinal disorders
Notes: Includes abdominal adhesion, abdominal pain, acid reflux, indigestion, food poisoning, GERD, gastric lesions, gastritis, stomach flu, gastrointestinal infection and peptic ulcer
Frequency: 9 affected / 106 at risk

Adverse event: Intestinal Issues
Serious: no
Organ System: Gastrointestinal disorders
Notes: Includes bowel irregularity, constipation, diverticulitis, GI bleed, inflammatory bowel syndrome, nausea, vomiting and diarrhea
Frequency: 11 affected / 106 at risk

Adverse event: Pregnancy Related Issues
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Includes pregnancy and delivery
Frequency: 3 affected / 106 at risk

Adverse event: Male Reproductive System Issues
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Includes epididymitis, erectile dysfunction, inguinal or testicular pain, rectocele and retrograde ejaculation
Frequency: 3 affected / 106 at risk

Adverse event: Female Reproductive System Issues
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Includes abnormal PAP smear results, breast, ovarian or uterine cyst, mass or tumor, cystocele, menopause, vaginal or yeast infection
Frequency: 1 affected / 106 at risk

Adverse event: Urinary Issues
Serious: no
Organ System: Renal and urinary disorders
Notes: Includes decreased urine output, bladder infection, hematuria, incontinence, dysuria, pelvic pain, urinary hesitance, retention, urgency or tract infection
Frequency: 7 affected / 106 at risk

Adverse event: Non-Procedure Allergic Reactions
Serious: no
Organ System: Immune system disorders
Notes: Includes seasonal and systemic allergic reactions
Frequency: 5 affected / 106 at risk

Adverse event: Infections
Serious: no
Organ System: Infections and infestations
Notes: Includes abscess, cellulitis and non-procedure wound infections
Frequency: 2 affected / 106 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 106 at risk

Adverse event: Blood cholesterol increased
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 106 at risk

Adverse event: Degenerative Joint Disease - Lumbar
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Includes ankylosing spondylitis, arthritis, arthropathy and facet joint degeneration
Frequency: 1 affected / 106 at risk

Adverse event: Plantar Fascitis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 106 at risk

Adverse event: Joint or Muscle Issues
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Includes non-lumbar benign mass or tumor, bursitis, ganglion cyst, gout, hallux rigidus, hiccups, hip joint pain, non-lumbar joint sprain, leg length discrepancy, SI joint pain, surgery, torn meniscus, torn hip labral tear and trigger finger
Frequency: 11 affected / 106 at risk

Adverse event: Pain in Non-Lumbar or Leg
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Includes ankle, back, upper extremities, neck and thoracic, fibromyalgia, and foot
Frequency: 14 affected / 106 at risk

Adverse event: Non-Lumbar Radiographic Observation
Serious: no
Organ System: Surgical and medical procedures
Notes: Includes disc bulge, protrusion and herniation
Frequency: 9 affected / 106 at risk

Adverse event: Lumbar and Lower Extremity Motor Deficit
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Includes general, persistent and transient unilateral and bilateral motor deficit
Frequency: 5 affected / 106 at risk

Adverse event: Lumbar and Lower Extremity Sensory Deficit
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Includes unilateral and bilateral general and upper extremity sensory deficit, positive or change in SLR test
Frequency: 16 affected / 106 at risk

Adverse event: Reflex Change or Abnormality
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 106 at risk

Adverse event: Non-Lumbar and Lower Extremity Deficit
Serious: no
Organ System: Nervous system disorders
Notes: Includes Bell's palsy, brain tumor, dysphagia, memory loss, headache, loss of consciousness, migraine, nerve entrapment, numbness, restlessness, seizure, tremor, vertigo, carpal tunnel, peripheral neuropathy, upper extremity motor/sensory deficits
Frequency: 7 affected / 106 at risk

Adverse event: Lower Extremity Pain
Serious: no
Organ System: Nervous system disorders
Notes: Includes unilateral and bilateral upper and lower leg
Frequency: 11 affected / 106 at risk

Adverse event: Lumbar Only Pain
Serious: no
Organ System: Nervous system disorders
Frequency: 30 affected / 106 at risk

Adverse event: Lumbar and Lower Extremity Pain
Serious: no
Organ System: Nervous system disorders
Notes: Includes lumbar + unilateral and bilateral radiation into upper and lower leg
Frequency: 23 affected / 106 at risk

Adverse event: Psychosocial Disorders
Serious: no
Organ System: Psychiatric disorders
Notes: Includes anxiety, bipolar and depressive disorders
Frequency: 5 affected / 106 at risk

Adverse event: Substance Related Disorders
Serious: no
Organ System: Psychiatric disorders
Notes: Includes substance dependence or withdrawal
Frequency: 1 affected / 106 at risk

Adverse event: Sleep Disorders
Serious: no
Organ System: Psychiatric disorders
Notes: Includes fatigue, sleepiness, somnolence and insomnia
Frequency: 2 affected / 106 at risk

Adverse event: Breathing Disorders
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Includes dyspnea, sleep apnea, cough and asthma
Frequency: 2 affected / 106 at risk

Adverse event: Respiratory Infections
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Includes bronchitis, respiratory and sinus infection
Frequency: 6 affected / 106 at risk

Adverse event: Other Respiratory Disorders
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Includes COPD, hemoptysis, pleuritic chest pain, reactive airway disease
Frequency: 4 affected / 106 at risk

Adverse event: Injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Includes motor vehicle accident, fall, trip, slip or twist
Frequency: 21 affected / 106 at risk

Adverse event: Index Procedure Related Wounds
Serious: no
Organ System: Surgical and medical procedures
Notes: Includes abscess, deep wound, dehiscence, dural injuries, erythema, drainage, inflammation, incisional hernia, incisional cellulitis, pain at incision site, suture reaction and wound infection
Frequency: 12 affected / 106 at risk