User's Manual

14 – US-ENGLISH
5. ADVERSE EVENTS
Clinical data presented in this section are from the Defender and
SafeR clinical studies. PARADYM RF DR 9550 is similar in design
and clinical function to the Defender devices. SafeR operation in
PARADYM RF is similar to that in the Symphony pacemaker. The
data provided are applicable to PARADYM RF DR 9550.
5.1. DEFENDER STUDY
Clinical study of Defender IV DR 612 included 60 devices implanted
in 60 patients, 38 in Europe (37 patients followed for a minimum of 3
months), and 22 in the U.S. (IDE G970282/S15) with a total device
exposure of 228.7 and 30.3 device months, respectively. No deaths,
serious adverse experiences or complications were judged to be
device-related, as determined by the investigator. The following
tables summarize the safety data for this study.
There was 1 death in the study that was classified as arrhythmic. The cause
of death was recurrent VT/VF which occurred 19 days post implant.
In the following tables, complications are defined as adverse device
effect, which cannot be treated or resolved by simple adjustments
(e.g. reprogramming) and requires intervention.
NOTE: The company classified as complications those adverse
device effects that were treated with surgery or with external
defibrillation of a ventricular cardiac event.
Observations are defined as symptomatic or asymptomatic clinical
events with potential adverse device effects that do not require
intervention or can be corrected by simple adjustments.
NOTE: The company classified as observations those adverse device
effects that were treated with programming changes, medication, or
other method that was not classified as a complication.
Two of the 38 Defender IV DR 612 patients in Europe (37 patients
followed for a minimum of 3 months) experienced a total of three