Filter
Top Products
Stratos LV/LV-T Technical Manual 33
Table 5: Summary of Complications – Stratos LV
Category
Number
of
Patients
% of
Patients
Number of
Complications
Complications
per patient-
year
Device-Related
Pocket
Infection or
Pain
2
2.7%
3 0.05
Total
2
2.7%
3 0.05
LV Lead-Related
High
Threshold /
No Capture
1 1.3% 1 0.02
Diaphragmatic
Stimulation
1 1.3% 1 0.02
Dislodgement 2 2.7% 2 0.03
Total
4 5.3% 4 0.06
RV Lead Related
High
Threshold /
No Capture
4 5.3% 4 0.06
Total
4 5.3% 4 0.06
Procedure
Pneumothorax 1 1.3% 1 0.02
User error 1 1.3% 1
0.02
Hematoma 1 1.3% 1
0.02
Total
3 4.0% 3 0.05
Total Lead
and
Procedure
Related
11 14.7% 14 0.22
Other Medical
Worsening
CHF
2 2.7% 2 0.03
Non-CHF
cardiac
symptoms
5 6.7% 5 0.08