Common Risks from Implantable Cardioverter Defibrillators

doi:10.19803/j.1672-8629.20240243

Abstract

Abstract: 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.

Key words: Implantable, Defibrillator, Heart, Adverse Event, Risk, Inadequate Shock, Premature Discharge of Battery, Depletelectrode Failure

CLC Number:

SHEN Xiaohua, ZHANG Longying, QIU Jingting, WU Zhengshan, ZHAO Yan. Common Risks from Implantable Cardioverter Defibrillators[J]. Chinese Journal of Pharmacovigilance, 2024, 21(11): 1284-1287.

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https://zgywjj.magtechjournal.com/EN/Y2024/V21/I11/1284

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