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. 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
5. ADVERSE EVENTS
Deaths 0 0 0 0
Explants 0 0 0 0
Serious pacemaker related
events outside the use of
SafeR (AAI <> DDD)
0 0 0 0
Non-serious pacemaker
related events outside the use
of SafeR (AAI <> DDD)
0 0 0 0
Serious events due to the use
of SafeR (AAI <> DDD)
0 0 0 0
Non-serious events related due
to the use SafeR (AAI <> DDD)
13 28.9 15 3.2
Serious non-pacemaker
related events
6 13.3 9 1.9
Non-serious non-pacemaker
related events
8 17.8 8 1.7
(a)
4.74 device years
Non-serious events due to the use of SafeR 2 (AAI <> DDD) included: delay in switching on
2nd degree AV block, inappropriate classification of a PAC, disagreement between markers
and recorded EGM, atrial pacing above the maximum rate, recycling on an R-wave in a
refractory period, and disagreement in the statistics for switches to DDD. No patient
symptoms were associated with these events.
SORIN – PLATINIUM DR – U460A
15