User's Manual

5. ADVERSE EVENTS
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
Event # of Patients* % of Patients # of Events Events/100
Device-
Years**
Change in ventricular sensing
threshold
1 2.6 1° 5.2
Device reset*** 1 2.6 1° 5.2
Inappropriate therapy for EMI 1 2.6 1° 5.2
Pneumothorax 1 2.6 1° 5.2
Pocket hematoma 2 5.3 2° 10.5
Pocket infection/hematoma 1 2.6 1° 5.2
Pocket infection from previous
pacemaker
1 2.6 1° 5.2
Prolonged implant procedure 1 2.6 1 5.2
Sensor acceleration during
telemetry***
1 2.6 1 5.2
Shock for VT in VF Zone 1 2.6 1° 5.2
Slow VT not converted by ATP
therapy
1 2.6 2° 10.5
Unsatisfactory sensing
threshold test***
2 5.3 2 10.5
Ventricular oversensing 3 7.9 3 15.7
* A patient can have more than one observation.
** There were 228.7 device months in this study.
***These observations would not have happened with the currently marketed device and
programmer.
°Investigator indicated that Defender IV DR did not cause or contribute to the event.
5.2. SAFER (AAI <> DDD) STUDY
Clinical study of the SafeR (AAI <> DDD) included 45 Symphony 2550 devices implanted in
45 patients. No serious adverse events were device- or feature-related. There were no
deaths in the study.
Table 1: Summary of Symphony safety data during study
Patients Number of events
Number of
patients
% of patients Number of
events
Events per
device year
(a)
14
SORIN – PLATINIUM DR – U460A