User Manual Part 3

CLINICAL STUDY - COMPANION
B-5
Table B-1. Device- and procedure-related adverse events (continued)
Total Events
(Patients)
% Comps
(Patients)
%Obs
(Patients)
Muscle stimulation
2 (2) 0.0 (0) 0.3 (2)
Myocardial infarction 2 (2) 0.0 (0) 0.3 (2)
Numbness
2 (2) 0.0 (0) 0.3 (2)
Perforation, venous 2 (2) 0.0 (0) 0.3 (2)
Phantom shock
2 (2) 0.0 (0) 0.3 (2)
Undersensing - atrium pace sense - b rady
2 (2) 0.2 (1) 0.2 (1)
Altered hemodynamic status
1 (1) 0.0 (0) 0.2 (1)
Arrhythmia
1 (1) 0.0 (0) 0.2 (1)
Arrhythmia - sinus tachycardia
1 (1) 0.0 (0) 0.2 (1)
Bruise
1 (1) 0.0 (0) 0.2 (1)
Cardiac arrest 1 (1) 0.2 (1) 0.0 (0)
Change in arrhythmia - SVT 1 (1) 0.0 (0) 0.2 (1)
Change in arrhythmia - brady 1 (1) 0.0 (0) 0.2 (1)
Change in arrhythmia - junctional 1 (1) 0.0 (0) 0.2 (1)
Change in physical status 1 (1) 0.0 (0) 0.2 (1)
Chest pain 1 (1) 0.0 (0) 0.2 (1)
Dizziness, cause undetermined
1 (1) 0.0 (0) 0.2 (1)
Edema
1 (1) 0.0 (0) 0.2 (1)
Fatigue
1 (1) 0.0 (0) 0.2 (1)
Febrile
1 (1) 0.0 (0) 0.2 (1)
Unable to urinate
1 (1) 0.0 (0) 0.2 (1)
Helix related (screw tip), b roken or stretched 1 (1) 0.2 (1) 0.0 (0)
Hemoglobin drop
1 (1) 0.2 (1) 0.0 (0)
Hypertension
1 (1) 0.0 (0) 0.2 (1)
Infection 1 (1) 0.2 (1) 0.0 (0)
Insulation breech observed
2 (1) 0.2 (1) 0.0 (0)
Malfunction, memo ry problem 1 (1) 0.2 (1) 0.0 (0)
Materials unretrieved in body
1 (1) 0.2 (1) 0.0 (0)
Pacemaker mediated tachycardia (PMT) 1 (1) 0.0 (0) 0.2 (1)
Pacemaker syndrome
1 (1) 0.0 (0) 0.2 (1)
- DRAFT -