Study: NCT02200939

Adverse event: Cardiac ablation
Serious: yes
Organ System: Cardiac disorders
Notes: Unrelated to device and procedure
Frequency: 1 affected / 33 at risk

Adverse event: Index shoulder pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated to device and procedure
Frequency: 1 affected / 33 at risk

Adverse event: Index shoulder pain and stiffness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated to device and procedure
Frequency: 1 affected / 33 at risk

Adverse event: Leg trauma
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Unrelated to device and procedure
Frequency: 1 affected / 33 at risk

Adverse event: Index shoulder subacromial fluid collection/inflammation
Serious: no
Organ System: Product Issues
Notes: Possibly related to device and procedure
Frequency: 1 affected / 33 at risk

Adverse event: Index shoulder pain and stiffness
Serious: no
Organ System: Product Issues
Notes: Possibly related to device and procedure
Frequency: 1 affected / 33 at risk

Adverse event: Index shoulder bicep tendonitis
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Unrelated to device and possibly related to procedure
Frequency: 1 affected / 33 at risk

Adverse event: Index shoulder rash
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Unrelated to device and definitely related to procedure
Frequency: 1 affected / 33 at risk

Adverse event: Index shoulder new rotator cuff tear and lack of healing
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated to device and procedure
Frequency: 1 affected / 115 at risk

Adverse event: Contralateral shoulder distal clavical excision, RCT debridement of degenerative labrum & bursectomy
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated to device and procedure
Frequency: 1 affected / 115 at risk

Adverse event: Index shoulder recurrent rotator cuff tear
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated to device and procedure
Frequency: 5 affected / 115 at risk

Adverse event: Index shoulder recurrent full thickness rotator cuff tear
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated to device and procedure
Frequency: 1 affected / 115 at risk

Adverse event: Pain in extremity
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Unrelated to device and procedure
Frequency: 1 affected / 115 at risk

Adverse event: Contralateral Rotator Cuff Tear
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated to device and procedure
Frequency: 1 affected / 115 at risk

Adverse event: Index shoulder swelling and drainage
Serious: yes
Organ System: Product Issues
Notes: Possibly related to device and procedure
Frequency: 1 affected / 115 at risk

Adverse event: Index shoulder pain, inflammatory changes, and osteopenia in the region of the greater tuberosity
Serious: yes
Organ System: Product Issues
Notes: Possibly related to device and procedure
Frequency: 1 affected / 115 at risk

Adverse event: Midthoracic pain; slow heartbeat; R clavicle nondisplaced fracture w/fibrous union & bone formation
Serious: no
Organ System: Cardiac disorders
Notes: Unrelated to device and procedure
Frequency: 1 affected / 115 at risk

Adverse event: Index shoulder pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated to device and procedure
Frequency: 1 affected / 115 at risk

Adverse event: Contralateral shoulder ache
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated to device and procedure
Frequency: 1 affected / 115 at risk

Adverse event: Contralateral shoulder pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated to device and procedure
Frequency: 1 affected / 115 at risk

Adverse event: Index shoulder superficial stitch abscess with continued wound drainage
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Unrelated to device and definitely related to procedure
Frequency: 1 affected / 115 at risk

Adverse event: Index shoulder asymptomatic recurrent rotator cuff tear
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Unrelated to device and possibly related to procedure
Frequency: 1 affected / 115 at risk

Adverse event: Index shoulder pain
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Unrelated to device and definitely related to procedure
Frequency: 1 affected / 115 at risk

Adverse event: Index shoulder proximal long-head biceps rupture
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Unrelated to device and possibly related to procedure
Frequency: 1 affected / 115 at risk

Adverse event: Index shoulder pain
Serious: no
Organ System: Product Issues
Notes: Possibly related to device and definitely related to procedure
Frequency: 1 affected / 115 at risk

Adverse event: Index shoulder recurrent rotator cuff tear
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Unrelated to device and possibly related to procedure
Frequency: 1 affected / 115 at risk