中国药物警戒 ›› 2013, Vol. 10 ›› Issue (6): 366-368.

• 药械安全性研究 • 上一篇    下一篇

植入式心脏起搏器常见风险点浅析

于文雯1, 赵燕2*, 青山3   

  1. 1.济南市药品不良反应监测中心,山东济南250013；
    2.国家药品不良反应监测中心,北京100045；
    3.贵阳市药品不良反应监测中心,贵州贵阳550001
  • 收稿日期:2016-03-09 修回日期:2016-03-09 出版日期:2013-06-08 发布日期:2016-03-09
  • 通讯作者: 赵燕,女,高级工程师,医疗器械不良事件监测。 E-mail:zhaoyan@cdr.gov.cn
  • 作者简介:于文雯,女,本科,医疗器械不良事件监测。

Analysis of Adverse Events and Related Factors of Implantable Cardiac Pacemaker

YU Wen-wen1, ZHAO Yan2 ,QING Shan   

  1. 1.Jinan adverse drug reaction monitoring center, Jinan 250013;
    2.Center for Drug Reevaluation, SFDA, Beijing 100045;
    3.Guiyang adverse drug reaction monitoring center, Guiyang 550001, China
  • Received:2016-03-09 Revised:2016-03-09 Online:2013-06-08 Published:2016-03-09

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摘要： 目的 探讨植入式心脏起搏器常见风险点及影响因素,并提出风险控制建议。方法 对文献中报道的植入式心脏起搏器有关可疑医疗器械不良事件案例进行检索,按不良事件发生原因进行归类分析,将仅为操作原因或器械本身质量原因引起的案例予以剔除。结果 共收集258例植入式心脏起搏器相关的可疑不良事件。其中排在前4位的为电极脱位、起搏器综合征、囊袋感染、囊袋破溃。结论 分析心脏起搏器的不良事件特点及提出风险点与风险控制措施,有助于提高临床对植入式心脏起搏器安全性的认识。进而重视术前预防,术中规范操作,加强术后随访及起搏器知识教育,早期发现并积极处理各种不良事件,确保此类产品的安全使用。

关键词: 植入式心脏起搏器, 医疗器械不良事件

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

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