46 Stratos LV/LV-T Technical Manual

Table 11: Summary of Observations at 6 months

 

 

 

Number of

 

% of

Number of

 

Observations

 

Category

 

 

 

per patient-

 

 

Patients

 

Patients

Observations

 

 

 

 

 

 

 

 

 

 

 

year

 

 

 

Device Related

 

 

 

 

Pocket

 

 

 

 

 

 

 

 

infection/

1

1.1%

1

0.02

 

 

Pericardial

 

 

 

 

 

 

 

 

 

 

Effusion

 

 

 

 

 

 

 

 

Total

1

1.1%

1

0.02

 

 

Total System

12

 

13.5%

13

 

0.21

 

 

Related

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Medical

 

 

 

 

 

Arrhythmias

2

 

2.2%

2

 

0.03

 

 

Shortness of

 

 

 

 

 

 

 

 

breath,

1

 

1.1%

1

 

0.02

 

 

palpitations

 

 

 

 

 

 

 

 

Total

3

 

3.3%

3

 

0.05

 

 

 

 

 

 

Miscellaneous

 

 

 

 

 

Malfunction of

 

 

 

 

 

 

 

 

hemostatic

1

 

1.1%

1

 

0.02

 

 

valve

 

 

 

 

 

 

 

 

Improper

 

 

 

 

 

 

 

 

Lead

1

 

1.1%

1

 

0.02

 

 

preparation

 

 

 

 

 

 

 

 

Total

2

 

2.2%

2

 

0.04

 

 

Overall

 

17

 

19.1%

18

 

0.28

 

 

Observation

 

 

 

 

 

Totals

 

 

 

 

 

 

 

 

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.