Abstract: Objective To explore the risk point of implantable cardiac pacemaker and offer the risk control measures respectively. Methods With retrospective case study, adverse events of implantable cardiac pacemaker were collected from the domestic literature and analyzed retrospectively. According to the reason of adverse events, the events caused by the operation or quality of the instrument itself were excluded. Results A total of 258 cases of adverse events were collected. The common complications were electrode dislocation, pacemaker syndrome, capsular infection and capsular rupture. Conclusion The control measures should be taken to decrease the risk of adverse events of implantable cardiac pacemaker. More attention should be paid on pre -operative prevention, operative manipulation and postoperative guidance. Early finding, diagnosis and therapy were effective Methods for preventing adverse events to raise the safety for clinical use.

Key words: implantable cardiac pacemaker, medical device adverse event