Recall devices: Defects at initial visit and during remote monitoring supported follow-up.

IF 1.3

Pacing and clinical electrophysiology : PACE Pub Date : 2022-11-01 Epub Date: 2022-07-09 DOI:10.1111/pace.14552

Maciej Grymuza, Lidia Chmielewska-Michalak, Agnieszka Katarzyńska-Szymańska, Jacek Migaj, Maciej Lesiak, Przemysław Mitkowski

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引用次数: 1

Abstract

Background: In March 2021, Biotronik informed about the risk of premature battery depletion in a group of implantable cardioverter-defibrillators. Following the manufacturers' recommendation, our center executed a recall and introduced remote monitoring (RM) in patients with susceptible devices. This study reports the rate of premature battery depletion in our center and events found in RM-supported follow-up.

Methods: Single-center observational study.

Results: Out of the 206 susceptible implanted devices, 125 patients appeared for the visit and RM was introduced in 107 (83%) patients. Until the visit, three (2.4%) devices required replacement due to battery depletion, and a further three (2.4%) devices had unexpected battery depletion during follow-up.

Conclusions: The recalled devices had a higher rate of battery exhaustion than expected, while other device or lead defects were less common.

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召回设备:在初始访问和远程监控期间的缺陷支持后续。

背景:2021年3月，Biotronik告知了一组植入式心律转复除颤器电池过早耗尽的风险。根据制造商的建议，我们中心进行了召回，并对使用易感器械的患者引入了远程监控(RM)。本研究报告了我们中心的电池过早耗尽率和rm支持随访中发现的事件。方法:单中心观察研究。结果:206例易感植入器械中，125例患者就诊，107例(83%)患者引入RM。在访问之前，有3台(2.4%)设备因电池耗尽而需要更换，另有3台(2.4%)设备在随访期间出现意外电池耗尽。结论:召回设备的电池耗尽率高于预期，而其他设备或铅缺陷较不常见。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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Pacing and clinical electrophysiology : PACE

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