User's Manual
Table Of Contents
- 1. General description
- 2. Indications
- 3. Contraindications
- 4. Warnings and precautions
- 5. Adverse events
- 6. Clinical studies
- 7. Patient selection and treatment
- 8. Patient counselling information
- 9. Declaration of conformity
- 10. Physician guidelines
- 11. Patient information
- 12. How supplied
- 13. Device description
- 14. Implant procedure
- 14.1. Necessary equipment
- 14.2. Packaging
- 14.3. Optional equipment
- 14.4. Before opening the package
- 14.5. Prior to implantation
- 14.6. Device placement
- 14.7. Choosing the type of lead
- 14.8. Shock configuration (+ -> -)
- 14.9. Measurement of thresholds at implant
- 14.10. Leads connection
- 14.11. Device implantation
- 14.12. Tests and programming
- 15. Special modes
- 16. Main functions
- 17. Patient follow-up
- 18. Supplemental Information
- 19. Physical characteristics
- 20. Electrical characteristics
- 21. Programmable parameters
- 22. Non programmable parameters
- 23. Limited warranty
- 24. Patents
- 25. Explanation of symbols
5. ADVERSE EVENTS
Worsening CHF/CHF
decompensation
24 12.6 42 2.1
Atrial fibrillation/flutter 14 7.4 14 0.7
Not Serious events not
related to the system
58 30.5 121 7.4
Pain (in back, arms, chest,
shoulder, groin, head, other)
10 5.3 13 0.7
Worsening CHF/CHF
decompensation
13 6.8 16 0.8
Atrial fibrillation/flutter 7 3.7 8 0.4
Ventricular tachycardia 7 3.7 7 0.4
5.2. POTENTIAL ADVERSE EVENTS
Adverse events (in alphabetical order), including those reported in the previous tables,
associated with ICD systems include:
─ Acceleration of arrhythmias (caused by device),
─ Air embolism,
─ Bleeding,
─ Chronic nerve damage,
─ Erosion,
─ Excessive fibrotic tissue growth,
─ Extrusion,
─ Fluid accumulation,
─ Formation of hematomas or cysts,
─ Inappropriate shocks,
─ Infection,
─ Keloid formation,
─ Lead abrasion and fracture,
─ Lead migration/dislodgment,
─ Myocardial damage,
─ Pneumothorax,
─ Shunting current or insulating myocardium during defibrillation with internal or external
paddles,
─ Potential mortality due to inability to defibrillate or pace,
─ Thromboemboli,
─ Venous occlusion,
─ Venous or cardiac perforation.
Patients susceptible to frequent shocks despite antiarrhythmic medical management may
develop psychological intolerance to an ICD system that may include the following:
─ Dependency,
─ Depression,
─ Fear of premature battery depletion,
─ Fear of shocking while conscious,
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SORIN – PLATINIUM CRT-D – U459A