Safety Analyses
EVENT, POSTOPERATIVE COMPLICATIONS
All patients undergoing implantation with a study device were included in the safety population. If a study device was explanted, data up to and including the date of the explantation were included in all analyses. Per the study protocol, patients with explanted devices, whether replaced or not, were expected to remain in the study and continue to complete their annual questionnaires, which were included in the analyses. Incidence of postoperative complications was analyzed with the Kaplan-Meier method. All event rates presented here were at the participant level (as opposed to the implant level), unless otherwise specified.