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
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Possible adverse device effects include complications due to the following:
Abnormal battery depletion
Conductor fracture
Device-programmer communication failure
Elevated or rise in defibrillation/cardioversion threshold
Inability to defibrillate or pace
Inability to interrogate or program due to programmer or device malfunction
Incomplete lead connection with pulse generator
Inhibited therapy including defibrillation and pacing
Inappropriate therapy (for example, shocks and antitachycardia pacing [ATP] where applicable,
pacing)
Interruption of function due to electrical or magnetic interference
Intolerance to high rate pacing (for example dyspnea or discomfort)
Lead abrasion
Lead fracture
Lead insulation damage