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46 Stratos LV/LV-T Technical Manual
Table 11: Summary of Observations at 6 months
Category
Number of
Patients
% of
Patients
Number of
Observations
Observations
per patient-
year
Device Related
Pocket
infection/
Pericardial
Effusion
1 1.1% 1 0.02
Total
1 1.1% 1 0.02
Total System
Related
12 13.5% 13 0.21
Medical
Arrhythmias 2 2.2% 2 0.03
Shortness of
breath,
palpitations
1 1.1% 1 0.02
Total
3 3.3% 3 0.05
Miscellaneous
Malfunction of
hemostatic
valve
1 1.1% 1 0.02
Improper
Lead
preparation
1 1.1% 1 0.02
Total
2 2.2% 2 0.04
Overall
Observation
Totals
17 19.1% 18 0.28
Number of Patients = 89; Number of Patient-Years = 63.3
There were a total of 10 patient deaths reported in the OVID
study for patients with the Stratos LV device. The clinical
investigators determined that no deaths were related to the
Stratos LV device system.