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首页> 外文期刊>PACE: Pacing and clinical electrophysiology >Unexpected ICD pulse generator failure due to electronic circuit damage caused by electrical overstress.
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Unexpected ICD pulse generator failure due to electronic circuit damage caused by electrical overstress.

机译：由于电气过应力引起的电子电路损坏，ICD脉冲发生器发生意外故障。

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摘要

Because it is a lifesaving device, the unexpected failure of an ICD can be catastrophic. We report ICD electronic circuit failure due to electrical overstress damage (EOS) to the high voltage hybird circuit and other electronic components in a series of ICD pulse generator models. Data were obtained from the Multicenter Registry of Pacemaker and ICD Pacemaker and Lead Failures, and from the manufactures' adverse event reports, that were in the FDA's Manufacturer and User Facility Device Experience (MAUDE) database. Of 16 nonbattery Guidant/CPI ICD pulse generator failures reported to the registry, 6 (38%) have been confirmed by the manufacturer to be EOS related, and Guidant/CPI has reported 273 such failures to the FDA as of 12/29/00. The signs of failure included loss of telemetry and inability to deliver therapy, and some patients have experienced serious adverse events. Hybrid circuit damage may have occurred during capacitor charging or reform, and the majority appears to have happened during normal ICD function. While the incidence of this problem is unknown, a management strategy should be adopted that includes routine follow-up every 3 months and device evaluation after a shock or exposure to external defibrillation or electrosurgical devices. This study suggests that additional data are needed to determine the incidence of this problem, and that our present methods for monitoring the performance of ICD's following market release are inadequate.
机译：因为它是一种救生设备，所以ICD的意外故障可能是灾难性的。我们报告了在一系列ICD脉冲发生器模型中，由于对高压杂波电路和其他电子组件的电气过应力损坏（EOS）而导致的ICD电子电路故障。数据来自FDA制造商和用户设施设备体验（MAUDE）数据库中的Pacemaker和ICD Pacemaker和Lead Leads多中心注册表以及制造商的不良事件报告。向注册表报告的16种非电池Guidant / CPI ICD脉冲发生器故障中，有6家（38％）已被制造商确认为与EOS相关，并且Guidant / CPI截至12/29/00向FDA报告了273种此类故障。 。失败的迹象包括遥测功能丧失和无法进行治疗，一些患者经历了严重的不良事件。混合电路损坏可能是在电容器充电或重整期间发生的，大多数似乎是在正常ICD功能期间发生的。虽然此问题的发生率未知，但应采取管理策略，包括每3个月进行例行随访，并对电击或暴露于外部除颤或电外科设备后的设备进行评估。这项研究表明，需要额外的数据来确定此问题的发生率，并且我们目前用于监视市场发布后ICD的性能的方法还不够。

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