BIOTRONIK Evia DR, Technical Manual

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24 Evia Technical Manual
Table 2: Adverse Events
Category
# of
Patients
with AEs
% of
Patients
with AEs
# of
AEs
AEs /
pt-yr
Complications - Total 14 9.3% 16 0.25
Lead Repositioning 11 7.3% 12 0.19
Medical 3 2.0% 4 0.06
Device-Related Events 0 0.0% 0 0.00
Observations - Total 42 27.8% 54 0.85
Sensing & Pacing 17 11.3% 20 0.31
Holter Evaluation 15 9.9% 15 0.23
Medical 11 7.3% 12 0.19
Arrhythmias 4 2.6% 4 0.06
B-KAC.V.U Software 3 2.0% 3 0.05
Number of Patients=151, Number of Patient-Years=63.7
5.1.3 Inos2+ CLS Clinical Study
The adverse events reported below are from the Inos2+ CLS
clinical study which investigated the principle of Closed Loop
Stimulation (CLS) and its regulation of heart rate. Additionally,
the Protos AxVx Clinical Evaluation study investigated the safety
and effectiveness of the AxVx algorithm in patients with a high
percentage of ventricular sensing (80% or more).
N
OTE
:
The Inos and Protos families of pulse generators are earlier
generations of BIOTRONIK devices. The CLS portion of the
Evia family of pulse generators is based upon the Inos and
Protos pulse generators.
The Inos Clinical Study involved 130 devices implanted in 129
patients with cumulative implant duration of over 1600 months
(mean implant duration 12.4 months).