User's Manual

TABLE OF CONTENTS
1. GENERAL DESCRIPTION ........................................................................................ 8
2. INDICATIONS ............................................................................................................ 9
3. CONTRAINDICATIONS........................................................................................... 10
4. WARNINGS AND PRECAUTIONS.......................................................................... 11
Risks related to medical environment ...................................................................... 12
Sterilization, storage and handling ........................................................................... 13
Implantation and device programming ..................................................................... 13
Lead evaluation and lead connection....................................................................... 14
Generator explant and disposal ............................................................................... 15
5. ADVERSE EVENTS................................................................................................. 16
MSP study ................................................................................................................ 16
Potential adverse events .......................................................................................... 17
6. CLINICAL STUDIES ................................................................................................ 18
MSP clinical study .................................................................................................... 18
7. PATIENT SELECTION AND TREATMENT ............................................................. 22
Individualization of treatment.................................................................................... 22
Specific patient populations...................................................................................... 22
8. PATIENT COUNSELLING INFORMATION ............................................................. 24
9. DECLARATION OF CONFORMITY ........................................................................ 25
10. PHYSICIAN GUIDELINES....................................................................................... 27
Physician training ..................................................................................................... 27
Directions for use ..................................................................................................... 27
Maintaining device quality ........................................................................................ 27
V-V Programming Recommendation........................................................................ 28
11. PATIENT INFORMATION ........................................................................................ 29
12. HOW SUPPLIED...................................................................................................... 30
Sterility...................................................................................................................... 30
Warranty and replacement policy............................................................................. 30
13. DEVICE DESCRIPTION .......................................................................................... 31
14. IMPLANT PROCEDURE ......................................................................................... 33
Necessary equipment............................................................................................... 33
Packaging................................................................................................................. 33
Optional equipment .................................................................................................. 33
Before opening the package .................................................................................... 34
Prior to implantation ................................................................................................. 34
Device placement..................................................................................................... 34
4.1.
4.2.
4.3.
4.4.
4.5.
5.1.
5.2.
6.1.
7.1.
7.2.
10.1.
10.2.
10.3.
10.4.
12.1.
12.2.
14.1.
14.2.
14.3.
14.4.
14.5.
14.6.
SORIN – PLATINIUM 4LV SonR CRT-D 1844 – U906A 5