BIOTRONIK Evia DR, Technical Manual

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Evia Technical Manual 21
5. Adverse Events
N
OTE
:
The Evia family of pulse generators is a successor to the
BIOTRONIK’s Dromos, Philos, Inos, Protos, and Cylos
families of pulse generators. Therefore, data from the
clinical studies of these earlier generations are used to
support the safety and efficacy of the Evia family of pulse
generators.
5.1 Observed Adverse Events
5.1.1 Dromos DR Clinical Study
The
Dromos DR
Clinical Study involved 273 patients with
cumulative implant duration of 1418 months (mean implant
duration 5.2 months). Eleven patients died during the course of
the trial; none of the deaths was judged to be device-related.
One Dromos DR pulse generator was explanted during the trial,
secondary to infection.
Table 1
reports the adverse events (AE) on a per patient and a
per patient-month basis. The last column gives the expected
time (in months) between events; i.e., the reciprocal of the
AE/patient-month rate.