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48 Stratos LV/LV-T Technical Manual
Table 12: OVID and AVAIL Complication-Free
Rate - Stratos LV
Category
Number
of
Patients
% of
Patients
Number of
Complications
Complications
per patient-
year
Device Related
Pocket
Infection
2 1.2% 3 0.02
Total 2 1.2% 3 0.02
Procedure
Pneumothorax 1 0.6% 1 0.01
User error 1 0.6% 1
0.01
Hematoma 1 0.6% 1
0.01
Total 3 1.8% 3 0.02
Total Lead,
Device and
Procedure
Related
21 12.8% 23 0.18
Other Medical
Arrhythmias
1 0.6% 1 0.01
Repeated
ablation
3 1.8% 3 0.02
Worsening
CHF
2 1.2% 2 0.02
Other Medical
3 1.8% 3 0.02
Non-CHF
cardiac
symptoms
3 1.8% 3 0.02
Total 11 6.7% 12 0.09
Total—All
Patients and
Categtories
29 17.7% 35 0.27
Number of Patients = 164 Number of Patient-Years = 127.7