BIOTRONIK Evia DR, Technical Manual

Page: 33 / 183

Evia Technical Manual 25
There were a total of 15 deaths during the course of the trial;
none of which was judged by the clinical study investigators to
be device related. Two devices were explanted during the trial.
One device was explanted secondary to pocket erosion. The
patient was subsequently implanted with another Inos device.
The other device was explanted because the patient needed ICD
therapy.
Table 3
provides a summary of adverse events that were
reported during the clinical study regardless of whether or not
the event was related to the pacemaker system. A complication
was defined as a clinical event that resulted in additional
invasive intervention. An observation was defined as a clinical
event that did not result in additional invasive intervention.
Table 3: Reported Adverse Events
Category
# of
Patients
with AEs
% of
Patients
with AEs
# of AEs AEs/ pt-yrs
Complications
Total
13 10.08% 15 0.11
Lead
repositioning 10 7.75% 11 0.08
Medical 4 3.10% 4 0.03
The Protos AxVx Clinical Evaluation study involved 21 patients.
There were no complications during the course of the study.