User Manual

TABLE OF CONTENTS
1. General description................................................................................................................ 5
2. Indications............................................................................................................................... 6
3. Contraindications....................................................................................................................7
4. Warnings and precautions.....................................................................................................8
4.1. Risks related to medical environment.......................................................................................9
4.2. Sterilization, storage and handling..........................................................................................10
4.3. Implantation and device programming....................................................................................10
4.4. Lead evaluation and lead connection......................................................................................11
4.5. Generator explant and disposal..............................................................................................12
5. Adverse events...................................................................................................................... 13
5.1. Defender study........................................................................................................................ 13
6. Clinical studies...................................................................................................................... 15
6.1. Defender study........................................................................................................................ 15
7. Patient selection and treatment...........................................................................................18
7.1. Individualization of treatment..................................................................................................18
7.2. Specific patient populations....................................................................................................19
8. Patient counselling information..........................................................................................20
9. Conformance to standards..................................................................................................21
10. Physician guidelines.............................................................................................................24
10.1. Physician training.................................................................................................................... 24
10.2. Directions for use.................................................................................................................... 24
10.3. Maintaining device quality.......................................................................................................24
11. Patient information............................................................................................................... 25
12. How supplied......................................................................................................................... 26
12.1. Sterility.................................................................................................................................... 26
12.2. Warranty and replacement policy............................................................................................26
13. Device description................................................................................................................ 27
14. Implant procedure................................................................................................................. 29
14.1. Necessary equipment.............................................................................................................29
14.2. Packaging............................................................................................................................... 29
14.3. Optional equipment.................................................................................................................29
14.4. Before opening the package...................................................................................................29
14.5. Prior to implantation................................................................................................................30
14.6. Device placement.................................................................................................................... 30
14.7. Choosing the type of lead.......................................................................................................30
14.8. Shock configuration (+ -> -).....................................................................................................31
14.9. Measurement of thresholds at implant....................................................................................31
14.10.Lead connection ..................................................................................................................... 31
14.11. Device implantation................................................................................................................. 33
14.12.Tests and programming...........................................................................................................33
15. Special modes....................................................................................................................... 34
15.1. Safety mode (nominal values).................................................................................................34
15.2. Magnet mode.......................................................................................................................... 34
15.3. Response in the presence of interference..............................................................................34
SORIN – INTENSIA VR 124 – U153A
3