User 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. Conformance to standards
- 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. Lead connection
- 14.11. Device implantation
- 14.12. Tests and programming
- 15. Special modes
- 16. Main functions
- 17. Patient follow-up
- 18. Physical characteristics
- 19. Electrical characteristics
- 20. Programmable parameters
- 21. Non programmable parameters
- 22. Limited warranty
- 23. Patents
- 24. Explanation of symbols
6. CLINICAL STUDIES
Event Europe (N=38) Number of events* Number of patients Percent of patients
Intent to treat but did
not
0 0 0.0
Non-device related
death
1 1 2.6
Explant 1 1 2.6
Complication 3 2 5.3
Observation 18 14 36.8
Serious non-related
other than death
12 7 18.4
Event All (N=60) Number of events* Number of patients Percent of patients
Intent to treat but did
not
0 0 0.0
Non-device related
death
1 1 1.7
Explant 1 1 1.7
Complication 3 2 3.3
Observation 18 14 23.3
Serious non-related
other than death
13 8 13.3
* A patient can have more than one complication, observation, or serious adverse event, not
device-related.
Device Failures and Replacements:
No device failures or replacements occurred with Defender IV DR 612 during the study.
SORIN – INTENSIA VR 124 – U153A
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