sorin Intensia VR 124, Руководство по имплантации

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5. ADVERSE EVENTS
5. ADVERSE EVENTS
Clinical data presented in this section are from the Defender study. INTENSIA VR 124 is
similar in design and function to the Defender devices. The data provided are applicable to
INTENSIA VR 124.
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 complications, including device failures and
replacements. Fourteen of the 38 Defender IV DR 612 patients experienced a total of 18
observations. Complications and observations are reported in Tables 1 and 2. It should be
noted that a patient can have more than one observation or complication. There were no
observations or complications in the U.S.
Table 1: Summary of European Clinical Complications
(Including Device Failures and Replacements)
All complications, 2 of 38 Defender IV DR 612 patients in Europe
Event # of Patients % of Patients # of Events Events/100
Device-Years*
Hematoma 1 2.6 1 5.2
Ventricular lead
migration/dislodgment 2 5.3 2 10.5
* There were 228.7 device months in this study.
Table 2: Summary of European Clinical Complications
(Including Patient Complaints)
All complications, 14 of 38 Defender IV DR 612 patients in Europe
SORIN – INTENSIA VR 124 – U153A 13