Study: NCT05251363

Adverse event: Solia S LBBA Lead Related - Lead Dislodgement
Serious: yes
Organ System: Product Issues
Frequency: 3 affected / 186 at risk

Adverse event: Procedure Related - Other Implant Procedure Related Adverse Event
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 186 at risk

Adverse event: Procedure Related - Deep Vein Thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 186 at risk

Adverse event: Procedure Related - Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 186 at risk

Adverse event: Procedure Related - Hospital Admission for any Reason Attributable to Implant Procedure
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 186 at risk

Adverse event: Procedure Related - Pneumo or Hemothorax Associated with Implant Procedure
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 186 at risk

Adverse event: Other Implanted System Related - RA Lead Dislodgement
Serious: yes
Organ System: Product Issues
Frequency: 4 affected / 186 at risk

Adverse event: Other Implanted System Related - Other Unexpected Complication Related to RA Lead
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 186 at risk

Adverse event: Other Implanted System Related - Other Pulse Generator Related Adverse Event
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 186 at risk

Adverse event: Other Implanted System Related - Abnormal RA Lead Performance
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 186 at risk

Adverse event: Not Implanted System or Procedure Related - Cardiac Disorders
Serious: yes
Organ System: Cardiac disorders
Frequency: 17 affected / 186 at risk

Adverse event: Not Implanted System or Procedure Related - Respiratory, Thoracic, and Mediastinal Disorders
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 11 affected / 186 at risk

Adverse event: Not Implanted System or Procedure Related - Surgical and Medical Procedures
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 10 affected / 186 at risk

Adverse event: Not Implanted System or Procedure Related - Infections and Infestations
Serious: yes
Organ System: Infections and infestations
Frequency: 8 affected / 186 at risk

Adverse event: Not Implanted System or Procedure Related - General Disorders
Serious: yes
Organ System: General disorders
Frequency: 8 affected / 186 at risk

Adverse event: Not Implanted System or Procedure Related - Renal and Urinary Disorders
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 5 affected / 186 at risk

Adverse event: Not Implanted System or Procedure Related - Gastrointestinal Disorders
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 186 at risk

Adverse event: Not Implanted System or Procedure Related - Hepatobiliary Disorders
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 186 at risk

Adverse event: Not Implanted System or Procedure Related - Vascular Disorders
Serious: yes
Organ System: Vascular disorders
Frequency: 4 affected / 186 at risk

Adverse event: Not Implanted System or Procedure Related - Neoplasms Benign, Malignant, and Unspecified
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 3 affected / 186 at risk

Adverse event: Not Implanted System or Procedure Related - Nervous System Disorders
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 186 at risk

Adverse event: Not Implanted System or Procedure Related - Injury, Poisoning and Procedural Complications
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 186 at risk

Adverse event: Not Implanted System or Procedure Related - Blood and Lymphatic System Disorders
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 186 at risk