Objective To analyze the common risks posed by implantable cardioverter defibrillators(ICD)and provide references for clinical safety.Methods The reports about ICD-related adverse events were retrieved from the medical device adverse event monitoring system database of one province between Jan 1,2015 and Mar 15,2024 and from Manufacturer and User Facility Device Experience of the US Food and Drug Administration.Combined with the domestic information on recalls,these reports were statistically analyzed.Results The device failures included inadequate shock,premature discharge of batteries and depletelectrode failure.The dominating injuries involved were secondary surgeries,infections,and arrhythmia.Conclusion Clinical medical personnel should have an intimate knowledge of the impact of adverse events of the product on patients,weigh the risk-benefit ratio of patients,select indications with caution,and standardize clinical use.Manufacturers should strengthen the post-marketing risk management of the product,analyze the possible causes of risks and use them as the pre-market risk factors,improve product design,enhance product performance,and reduce the inherent risk of products.
关键词
植入式/除颤器/心脏/不良事件/风险/误放电/电池提前耗竭/电极导线故障
Key words
Implantable/Defibrillator/Heart/Adverse Event/Risk/Inadequate Shock/Premature Discharge of Battery/Depletelectrode Failure
维普
万方数据