St. Jude Medical Tendril MRI LPA1200M, Руководство пользователя

Страница: 17 / 38

15
Figure 3. Number of patients attempted and implanted with the Accent MRI pacemaker and
Tendril MRI lead
The figure below displays the number of patients who contributed data to the MRI phase.
Figure 4. Number of patients participating in MRI phase/contributing scan data
As of October 30, 2014, the total time of follow-up from the time of successful implant was
18,425 patient-months. The average time of follow-up was 20.00 ± 4.66 (range 0.09 to 30.68)
patient-months.
Demographic Data
As part of the Lead Safety Phase of the MRI Study, patients who were successfully implanted with
the Accent MRI
™
pacemaker system were seen at a pre-discharge visit during which the following
tests/assessments were performed: electrical measurements on the RA and/or RV leads and
identification of the radiopaque markers on the lead and pacemaker. Patients were again seen at
two months post-implant, six months post-implant, 12 months post-implant, and every six months