User's Manual

TABLE OF CONTENTS
1. General description .................................................................... 6
2. Indications ................................................................................... 6
3. Contraindications ....................................................................... 6
4. Warnings and precautions ........................................................ 7
4.1. Risks related to medical environment ........................... 8
4.2. Sterilization, storage and handling .............................. 10
4.3. Implantation and device programming ........................ 11
4.4. Lead evaluation and lead connection .......................... 12
4.5. Generator explant and disposal ................................... 13
5. Adverse events ......................................................................... 14
5.1. Defender study ............................................................... 14
5.2. SafeR study .................................................................... 17
6. Clinical studies ......................................................................... 19
6.1. Defender study ............................................................... 19
6.2. SafeR study .................................................................... 23
7. Patient selection and treatment .............................................. 28
7.1. Individualization of treatment ....................................... 28
7.2. Specific patient populations ......................................... 29
8. Patient counselling information .............................................. 30
9. Conformance to standards ...................................................... 30
10. Physician guidelines ................................................................ 34
10.1. Physician training .......................................................... 34
10.2. Directions for use........................................................... 34
10.3. Maintaining device quality ............................................ 34
11. Patient information ................................................................... 35
12. How supplied ............................................................................ 35
12.1. Sterility ............................................................................ 35
12.2. Warranty and replacement policy ................................ 35