User's Manual

ManualsBrandsSORIN CRM ManualsElectronicsImplantable Cardioverter defibrillator with RF wireless communication availability

Table Of Contents

1. General description
2. Indications
3. Contraindications
4. Warnings and precautions
- 4.1. Risks related to medical environment
- 4.2. Sterilization, storage and handling
- 4.3. Implantation and device programming
- 4.4. Lead evaluation and lead connection
- 4.5. Generator explant and disposal
5. Adverse events
- 5.1. MSP study
- 5.2. Potential adverse events
6. Clinical studies
- 6.1. MSP clinical study
7. Patient selection and treatment
- 7.1. Individualization of treatment
- 7.2. Specific patient populations
8. Patient counselling information
9. Declaration of conformity
10. Physician guidelines
- 10.1. Physician training
- 10.2. Directions for use
- 10.3. Maintaining device quality
11. Patient information
12. How supplied
- 12.1. Sterility
- 12.2. Warranty and replacement policy
13. Device description
14. Implant procedure
- 14.1. Necessary equipment
- 14.2. Packaging
  - 14.2.1. Contents
- 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
- 15.1. Safety mode (nominal values)
- 15.2. Magnet mode
- 15.3. Response in the presence of disturbance
- 15.4. Detection characteristics in the presence of electromagnetic fields
- 15.5. Protection against short-circuits
16. Main functions
- 16.1. Automatic lead measurements
- 16.2. Atrial tachyarrhythmia management
- 16.3. Ventricular tachyarrhythmia management
- 16.4. Pacing
- 16.5. Sensing
- 16.6. LV Multipoint Pacing (MP)
- 16.7. Follow-up function
- 16.8. Remote Monitoring function
17. Patient follow-up
- 17.1. Follow-up recommendations
- 17.2. Holter Function
  - 17.2.0.1. Stored Tachyarrythmia Episodes:
  - 17.2.0.2. Therapy history
- 17.3. Recommended Replacement Time (RRT)
- 17.4. Explantation
- 17.5. Defibrillator identification
18. Supplemental Information
- 18.1. Adverse events in the SafeR (AAI <> DDD) study
  - 18.1.0.3. Table 1: Summary of Symphony safety data during study
- 18.2. SafeR (AAI <> DDD) clinical study
19. Physical characteristics
- 19.1. Materials used
20. Electrical characteristics
- 20.1. Table of delivered shock energy and voltage
- 20.2. Battery
- 20.3. Longevity
21. Programmable parameters
- 21.1. Antibradycardia pacing
- 21.2. Ventricular tachyarrhythmia detection
- 21.3. Ventricular tachyarrhythmia therapies
- 21.4. Remote alerts and warnings
22. Non programmable parameters
23. Limited warranty
24. Patents
25. Explanation of symbols

Event # of Pa-

tients

% of Pa-

tients

# of

Events

Events/100

Device-

Years

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

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,

― Fear that shocking capability may be lost,

― Imagined shocking (phantom shock).

5.2.

5. ADVERSE EVENTS

SORIN – PLATINIUM 4LV CRT-D 1744 – U904A 17