Boston Scientific Corporation CRMA20914 User Manual
17
Accountability of PMA Cohort
Of 330 patients enrolled in PMA study, 321 underwent an implant procedure, of whom 314 were implanted with the S-ICD
Of 330 patients enrolled in PMA study, 321 underwent an implant procedure, of whom 314 were implanted with the S-ICD
System. There were 293 patients still active at the time of database lock on February 14, 2012. The mean follow-up duration
for all patients implanted was 330 days with a range of 17 to 715 days. Cumulative time of follow-up for all implanted
patients was 3,410 months. The disposition of all study participants is summarized in Figure 1 below:
Figure 1: Summary of Patient Status as of 14 February, 2012
Enrolled
n=330
Implant Attempt
n=321
Withdrawn Prior to
Implant Procedure
n=9
Active
n=293
Discontinued
n=21
(11 Explanted,
2 Withdrawn,
8 Deaths)
Not Implanted
n=7
(All 7 Withdrawn)
Implanted
n=314