Doran Joseph, Ward Max, Ward Brittany, Paskhover Boris, Umanoff Michael, Mammis Antonios
Department of Neurological Surgery, Rutgers New Jersey Medical School, Newark, NJ, USA.
Rutgers New Jersey Medical School, Newark, NJ, USA.
Neuromodulation. 2018 Apr;21(3):296-301. doi: 10.1111/ner.12750. Epub 2018 Jan 18.
The objectives of this study are to utilize the MAUDE data base to enhance our understanding of the complication profile for Occipital Nerve Stimulation, a therapy for which the current level of evidence is limited. Additionally, it is our objective to describe a systematic approach to processing the MAUDE data, which addresses its flaws and enhances its utility.
From the FDA website, we accessed adverse events reports from the MAUDE data base for devices used in Occipital Nerve Stimulation between June 30, 2007 and June 30, 2017. All reports were sorted into an overall classification for types of adverse events, types of patient complaints, and types of specific device-related complications. We then evaluated for the total number of adverse event reports that contained each of the patient complains and device-related complications.
A total of 1233 adverse event records were obtained. Eight hundred twenty-two records were classified as surgically manageable post-operative complications, 121 as device malfunction, 29 as patient compliance issues, and 27 as intra-operative complications. Two hundred thirty-seven records were not classified. A total of 683 records contained patient complaints including 467 complaints of ineffective stimulation, 122 complaints of inappropriate or over-stimulation, 50 complaints of device-shock, and 44 complaints of IPG site pain. We found 581 post-operative device-related complications, which included 206 instances of lead migration, 157 reports of lead erosion, 155 infections, 46 lead-fractures, and 17 lead disconnections.
The MAUDE data base is a useful tool to investigate device related complications and helps fill the current gap in ONS data. Reviewing the types and frequencies of complications reported over the years allows clinicians with less personal experience to have a more realistic expectation of complications and make informed decisions based on the patient's unique needs. Additionally, patient complaint data are useful in establishing more realistic expectations for patient outcomes.
本研究的目的是利用MAUDE数据库，加深我们对枕神经刺激并发症情况的理解，目前该疗法的证据水平有限。此外，我们的目标是描述一种处理MAUDE数据的系统方法，该方法能解决其缺陷并提高其效用。
从美国食品药品监督管理局（FDA）网站，我们获取了2007年6月30日至2017年6月30日期间MAUDE数据库中用于枕神经刺激设备的不良事件报告。所有报告按照不良事件类型、患者投诉类型和特定设备相关并发症类型进行总体分类。然后我们评估包含每种患者投诉和设备相关并发症的不良事件报告总数。
共获得1233条不良事件记录。822条记录被归类为手术可处理的术后并发症，121条为设备故障，29条为患者依从性问题，27条为术中并发症。237条记录未分类。共有683条记录包含患者投诉，其中467条为刺激无效投诉，122条为不适当或过度刺激投诉，50条为设备电击投诉，44条为植入式脉冲发生器（IPG）部位疼痛投诉。我们发现581例术后设备相关并发症，其中包括206例导线移位、157例导线侵蚀报告、155例感染、46例导线断裂和17例导线断开。
MAUDE数据库是调查设备相关并发症的有用工具，有助于填补目前枕神经刺激数据的空白。回顾多年来报告的并发症类型和频率，使经验较少的临床医生对并发症有更现实的预期，并根据患者的独特需求做出明智的决策。此外，患者投诉数据有助于对患者预后建立更现实的预期。
