Disproportionality analysis for signal detection of implantable cardioverter-defibrillator-related adverse events in the Food and Drug Administration Medical Device Reporting System
Disproportionality analysis for signal detection of implantable cardioverter-defibrillator-related adverse events in the Food and Drug Administration Medical Device Reporting System
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DOI：
10.1002/pds.2261
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发表时间：
2012-01-01
影响因子：
2.6
通讯作者：
Marinac-Dabic, Danica
中科院分区：
文献类型：
--
作者：
Duggirala, Hesha J.;Herz, Naomi D.;Marinac-Dabic, Danica
背景美国食品药品监督管理局（FDA）于2007年1月意识到与Sprint Fidelis电极导线相关的电极导线断裂和不当电击事件。该制造商于2007年10月宣布自愿退出市场。目的我们的目的是回顾性地评估这一安全信号，使用非线性分析，以估计非线性分析是否可以检测到这一特定的安全信号早于实际发生。材料和方法制造商和用户机构设备经验（MAUDE）数据库包含有关设备相关不良事件的报告，其中，林业发展局每年收到几十万美元。对于每个制造商，都会根据报告频率对顶级领先品牌进行排名。我们使用多项伽马泊松收缩（MGPS）方法进行分析。我们分离出11个报告最多的植入式心律转复除颤器（ICD）电极导线品牌。使用MGPS的方法，我们计算了单侧95%置信下限EB05的经验贝叶斯几何平均值的报告ratio.Results我们进行了个别MGPS分析，在2006年的ICD导线的不良事件报告的每一个顶部。Fidelis有最高的EB05分数为导线断裂和不适当shock.Discussion通过MAUDE数据库的非线性分析，我们能够识别与Medtronic Sprint Fidelis lead.Conclusion相关的已知安全信号，如果在当时使用，这种非线性分析将识别信号更早的导线断裂，过感知，高阻抗，和不适当的shock。版权所有（C）2011约翰威利父子有限公司
Background The Food and Drug Administration (FDA) became aware of lead fracture and inappropriate shock events related to Sprint Fidelis leads in January 2007. The manufacturer announced a voluntary market withdrawal in October 2007.Aim Our aim was to retrospectively evaluate this safety signal using disproportionality analysis to estimate whether disproportionality analysis could have detected this particular safety signal earlier than actually occurred.Materials and Methods The Manufacturer and User Facility Device Experience (MAUDE) database contains reports on device-related adverse events, of which, FDA receives several hundred thousand every year. For each manufacturer, a list of the top lead brand names was ranked by frequency of reports. We used the Multi-item Gamma Poisson Shrinker (MGPS) method for analysis. We isolated 11 top-reported implantable cardioverter defibrillator (ICD) lead brand names. Using MGPS methodology, we calculated the one-sided 95% lower confidence bound EB05 on the empirical Bayes geometric mean of the reporting ratio.Results We performed individual MGPS analysis for each of the top reported adverse events in 2006 for ICD leads. Fidelis had the highest EB05 scores for lead fractures and inappropriate shock.Discussion Through disproportionality analysis of the MAUDE database, we were able to identify known safety signals associated with the Medtronic Sprint Fidelis lead.Conclusion If utilized at the time, this disproportionality analysis would have identified signals earlier for lead fractures, oversensing, high impedance, and inappropriate shock. Copyright (C) 2011 John Wiley & Sons, Ltd.