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34 Stratos LV/LV-T Technical Manual
Table 5: Summary of Complications – Stratos LV
Category
Number
of
Patients
% of
Patients
Number of
Complications
Complications
per patient-
year
Repeated
ablation
3 4.0% 3 0.05
Lead addition 1 1.3% 1 0.02
Other medical 3 4.0% 3 0.05
Total
12 16.0% 14 0.22
Total—All
Patients and
Categories
20 26.7% 28 0.43
Number of Patients = 75, Number of Patient-Years = 64.4
Table 6: Summary of Observations – Stratos LV
Category
Number
of
Patients
% of
Patients
Number of
Complications
Observations
per patient-
year
LV Lead-Related
High Threshold
/ No Capture
1
1.3%
1 0.02
Diaphragmatic
Stimulation
13
17.3%
13 0.20
Total
14 18.7% 14 0.22
Device Related
Pocket Infection
or pain
5 6.7% 5 0.08
Total
5 6.7% 5 0.08
Procedure
Pneumothorax 1 1.3% 1 0.02
Atrial edema 1 1.3% 1 0.02
User error 1 1.3% 1 0.02
Total
3 4.0% 3 0.05
Total Lead,
Device and
Procedure
Related
19 25.3% 22 0.34