99例植入式心脏起搏器可疑不良事件报告分析

目的对99例植入式心脏起搏器可疑不良事件进行分析，为植入式心脏起搏器不良事件监测提供参考。方法采用回顾性研究方法，对国家药品不良反应监测中心收到的99例植入式心脏起搏器可疑不良事件报告及其质量进行综合分析。结果不良事件表现以电池提前耗竭和死亡为主；报告表填写存在缺项现象，质量有待提高。结论进一步加强宣传培训，提高报告质量；建立产品跟踪制度，加强不良事件后续调查，保障公众用械安全。

Analysis of 99 Reports of Adverse Events on Implantable Pacemaker

Objective To provide suggestion for adverse events monitoring on Implantable Pacemaker with analyzing 99 cases of adverse events on Implantable Pacemaker. Medthods With retrospective case study,analyze 99 adverse events reports on Implantable Pacemaker received by National Center for ADP,. Monitoring, China. Results The most adverse events are premature battery depletion and death.The items of the reports are incompletely,and the quality needs to be improved. Conclusion Further steps should be taken to strengthen the training to improve the quality of the reports,setup quality tracking system and strengthening the investigation of adverse events to raise the safety for clinical use.