Table 5.

Implant procedure-, device-, or delivered-therapy-related serious adverse events through 24 months of follow-up

Event	Pooled groups (N = 151)
Any event	15 (10%)
Concomitant device interaction	3 (2%)
Lead component failure	2 (1%)
Lead dislodgment	2 (1%)
Implant site infection	2 (1%)
Impending pocket erosion	2 (1%)
Inadequate lead position	1 (1%)
Lead displacement	1 (1%)
Feeling sensation in an area remote from the diaphragm	1 (1%)
Implant site hematoma	1 (1%)
Noncardiac chest pain	1 (1%)
Elevated transaminase	1 (1%)

Reported as number with event (percent). All events resolved with routine care, system revisions, or programming changes.