Study: NCT01592344

Adverse event: heart arrhythmia
Serious: yes
Organ System: Cardiac disorders
Notes: Unrelated to device
Frequency: 1 affected / 45 at risk

Adverse event: Kidney failure and bladder tumor
Serious: yes
Organ System: Renal and urinary disorders
Notes: unrelated to device
Frequency: 3 affected / 45 at risk

Adverse event: gall bladder
Serious: yes
Organ System: Hepatobiliary disorders
Notes: cholelithiasis and cholecystectomy not device related
Frequency: 1 affected / 45 at risk

Adverse event: Bone fracture, instability, compromise
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Knee replacement, rotator cuff repair, spine instability/leak, bone fracture all unrelated to device
Frequency: 3 affected / 45 at risk

Adverse event: Respiratory issues
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: unrelated to device: pneumonia, breathing problems
Frequency: 2 affected / 45 at risk

Adverse event: dermatological issues
Serious: yes
Organ System: Infections and infestations
Notes: unrelated abscess, cellulitis, infection,
Frequency: 1 affected / 45 at risk

Adverse event: Localized pain irritation to patch/wound site
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 15 affected / 45 at risk

Adverse event: Gastrointestinal
Serious: no
Organ System: Gastrointestinal disorders
Notes: diarrhea, diverticulitis, nausea
Frequency: 3 affected / 45 at risk

Adverse event: renal
Serious: no
Organ System: Renal and urinary disorders
Notes: kidney stone, urinary tract infection, kidney function
Frequency: 3 affected / 45 at risk

Adverse event: Respiratory
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: flu, cough
Frequency: 2 affected / 45 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Notes: sinusitis
Frequency: 1 affected / 45 at risk

Adverse event: Musculoskeletal
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Joint spine issues
Frequency: 4 affected / 45 at risk

Adverse event: Sexual dysfunction
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Delayed ejaculation
Frequency: 1 affected / 45 at risk

Adverse event: Dehydration
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 45 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 2 affected / 45 at risk

Adverse event: Medicine wthdrawn in error
Serious: no
Organ System: General disorders
Frequency: 1 affected / 45 at risk

Adverse event: Lead exposure
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: lead implanted too superficially, skin scratched by patient until lead became exposed requiring repositioning of lead
Frequency: 1 affected / 45 at risk

Adverse event: heart arrhythmia
Serious: yes
Organ System: Cardiac disorders
Notes: Unrelated to device
Frequency: 1 affected / 49 at risk

Adverse event: gall bladder
Serious: yes
Organ System: Hepatobiliary disorders
Notes: cholelithiasis and cholecystectomy not device related
Frequency: 2 affected / 49 at risk

Adverse event: Bone fracture, instability, compromise
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Knee replacement, rotator cuff repair, spine instability/leak, bone fracture all unrelated to device
Frequency: 3 affected / 49 at risk

Adverse event: Digestive issues
Serious: yes
Organ System: Gastrointestinal disorders
Notes: diverticulitis not device related
Frequency: 2 affected / 49 at risk

Adverse event: dermatological issues
Serious: yes
Organ System: Infections and infestations
Notes: unrelated abscess, cellulitis, infection,
Frequency: 2 affected / 49 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: unrelated dehydration
Frequency: 1 affected / 49 at risk

Adverse event: Localized pain irritation to patch/wound site
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 16 affected / 49 at risk

Adverse event: Gastrointestinal
Serious: no
Organ System: Gastrointestinal disorders
Notes: diarrhea, diverticulitis, nausea
Frequency: 3 affected / 49 at risk

Adverse event: renal
Serious: no
Organ System: Renal and urinary disorders
Notes: kidney stone, urinary tract infection, kidney function
Frequency: 2 affected / 49 at risk

Adverse event: Respiratory
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: flu, cough
Frequency: 1 affected / 49 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Notes: sinusitis
Frequency: 2 affected / 49 at risk

Adverse event: Psychiatric
Serious: no
Organ System: Psychiatric disorders
Notes: confusion, dementia
Frequency: 1 affected / 49 at risk

Adverse event: Musculoskeletal
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Joint spine issues
Frequency: 7 affected / 49 at risk

Adverse event: Fall/bruising
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Falling due to frailty
Frequency: 2 affected / 49 at risk