Product Card
Table Of Contents
- Device Description
- Intended Use
- Indications
- Intended Clinical Benefits
- MRI Safety Information
- Contraindications
- Warnings
- Precautions
- Implantation Procedure
- Device Modification
- Storage and Handling
- Temperature Equilibrium
- Lead Impedance
- Suboptimal Bluetooth Communication
- Disconnecting Leads and Avoiding Shock While Handling
- External Equipment for Arrhythmia Induction
- Antiarrhythmic Drugs
- Sterilization
- Damaged Package
- Environmental Hazards
- Hospital and Medical Environments
- Environmental and Medical Therapy Hazards
- Home and Industrial Environments
- Transcutaneous Electrical Nerve Stimulation
- Radiofrequency Ablation
- Electronic Article Surveillance (EAS)
- Metal Detectors
- Cellular Phones
- Adverse Events
- Pulse Generator Header
- Sensing
- Radiopaque Identification
- Implanting the Pulse Generator
- Managing and Following Patients
- Device Longevity
- Using a Magnet
- Explanting the Pulse Generator
- Out-of-Service/Explant/Patient Death Form
- Technical Support
- Additional Information
- Physical Specifications
- Battery Information
- Device Configurations
- Inductive Communication
- BLE Operating Frequencies
- Spare Parts and Accessories
- Detection Performance in the Presence of Electromagnetic Interference in Differential Mode
- Symbols
22
Myocardial damage
Nerve damage
Occlusion/Thrombus
Pericardial effusion
Pericarditis
Pneumothorax
Pulmonary edema
Syncope
Thrombosis
Valve damage
Complications reported with direct subclavian venipuncture include pneumothorax, hemothorax,
laceration of the subclavian artery, arteriovenous fistula, neural damage, thoracic duct injury,
cannulation of other vessels, massive hemorrhage and rarely, death.
Among the psychological effects of device implantation are imagined pulsing, depression, dependency,
fear of premature battery depletion, device malfunction, inappropriate pulsing, shocking while
conscious, or losing pulse capability.