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Stratos LV/LV-T Technical Manual 45
Table 10: Summary of Complications at 6 months
Category
Number
of
Patients
% of
Patients
Number of
Complications
Complications
per patient-
year
Device Related
Pocket
infection
1 1.1% 1 0.02
Total
1 1.1% 1 0.02
Total System
Related
10 11.2% 10 0.16
Other Medical
Arrhythmias 1 1.1% 1 0.02
Total
1 1.1% 1 0.02
Overall
Complication
Totals
10 11.2% 11 0.17
Number of Patients = 89; Number of Patient-Years = 63.3
Table 11: Summary of Observations at 6 months
Category
Number of
Patients
% of
Patients
Number of
Observations
Observations
per patient-
year
Corox OTW/Steroid Lead-Related
Implant failure 5 5.6% 5 0.08
Phrenic nerve
stimulation
4 4.5% 4 0.06
Total
9 10.1% 9 0.14
Atrial Lead Related
Loss of
capture
1 1.1% 1 0.02
Total
1 1.1% 1 0.02
RV Lead Related
Elevated
Pacing
thresholds
2 2.2% 2 0.03
Total
2 2.2% 2 0.03