Table 1.

Definition of combined major complications by study

Author, Year	Definition
Moore, 2009(14)	Death + any complication requiring reoperation (infection, bleeding/hematoma, system malfunction)
Amin, 2008(9)	Death + any complication associated with device replacement
Mahajan, 2008(23)	Death + any complication associated with reoperation
Costea, 2008(15)	Death + any complication requiring reoperation (bleeding/hematoma, lead damage, device “protrusion”) + stroke
Kapa, 2007(12)	Any complication requiring intervention or reoperation up to 60 days post procedure
Hauser, 2006(11)	Death
Gould, 2006(24)	Death + any complication requiring reoperation (infection, bleeding, system malfunction, pain)