Auditory brainstem implants: an analysis of adverse events in the MAUDE database

IF 1.5 4区医学 Q4 CLINICAL NEUROLOGY Neurochirurgie Pub Date : 2024-05-28 DOI:10.1016/j.neuchi.2024.101570

Olivia E. Speed , Soroush Farsi , Kaersti Rickels , Vijay A. Patel , Anna Bareiss , John Dornhoffer , Robert A. Saadi

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Abstract

Objective

Auditory Brainstem Implants (ABI) are used to restore hearing in patients lacking appropriate cochlear anatomy and/or cochlear nerve. The objective of this study was to examine the Manufacture and User Facility Device Experience (MAUDE) database to analyze adverse events.

Study design

This is a study of a multi-institutional database maintained by the US FDA.

Setting

A database analysis was performed via collaboration of multiple clinicians at tertiary referral centers.

Methods

The MAUDE database was queried for Medical Device Reports (MDRs) relating to ABIs. MDRs were identified using the advanced search term “Implant, Auditory Brainstem” and reviewing all reports with the basic search term “Brainstem Implant”. All collected reports were individually reviewed.

Results

A total of 265 individual patient reports were reviewed, of which 55 reports met inclusion criteria. Reports regarding audiologic outcome included failure to provide hearing benefit (n = 27), implant failure/device malfunction (n = 10), and device non-use (n = 6). Postoperative complications included local skin infection (n = 3), CSF leak (n = 3), elevated ICP (n = 1), surgical site dehiscence (n = 1), swelling (n = 1), seroma formation requiring drainage (n = 1), and meningitis (n = 2). Two patients had dislodged magnets during 1.5 Tesla MRI acquisition. There were 35 instances of full explantation of the device and 1 partial removal; 13 patients had a new device implanted following explantation.

Conclusions

Poor hearing results, device failure, and non-use were commonly reported causes for explanation in this analysis. This information can aid physicians in counseling patients and family members and managing device expectations.

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听性脑干植入：MAUDE 数据库中的不良事件分析。

目的：听性脑干植入体（ABI）用于恢复缺乏适当耳蜗解剖结构和/或耳蜗神经的患者的听力。本研究的目的是检查制造和用户设施设备经验（MAUDE）数据库，分析不良事件：研究设计：这是一项对美国 FDA 维护的多机构数据库的研究：通过三级转诊中心多位临床医生的合作进行数据库分析：在 MAUDE 数据库中查询与 ABI 相关的医疗器械报告 (MDR)。使用高级检索词 "植入物，听性脑干 "确定MDR，并使用基本检索词 "脑干植入物 "审查所有报告。对收集到的所有报告进行逐一审查：结果：共审查了 265 份患者报告，其中 55 份符合纳入标准。有关听力结果的报告包括未能提供听力益处（n = 27）、植入失败/设备故障（n = 10）和设备未使用（n = 6）。术后并发症包括局部皮肤感染（3 例）、CSF 泄漏（3 例）、ICP 升高（1 例）、手术部位开裂（1 例）、肿胀（1 例）、需要引流的血清肿形成（1 例）和脑膜炎（2 例）。两名患者在 1.5 特斯拉磁共振成像采集过程中磁铁脱落。有 35 例完全拆卸设备，1 例部分拆卸；13 例患者在拆卸设备后植入了新设备：结论：在本次分析中，听力效果不佳、装置故障和未使用是常见的解释原因。这些信息有助于医生为患者和家属提供咨询，并管理他们对装置的期望。

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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来源期刊

Neurochirurgie 医学-临床神经学

CiteScore

2.70

自引率

6.20%

发文量

100

审稿时长

29 days

期刊介绍： Neurochirurgie publishes articles on treatment, teaching and research, neurosurgery training and the professional aspects of our discipline, and also the history and progress of neurosurgery. It focuses on pathologies of the head, spine and central and peripheral nervous systems and their vascularization. All aspects of the specialty are dealt with: trauma, tumor, degenerative disease, infection, vascular pathology, and radiosurgery, and pediatrics. Transversal studies are also welcome: neuroanatomy, neurophysiology, neurology, neuropediatrics, psychiatry, neuropsychology, physical medicine and neurologic rehabilitation, neuro-anesthesia, neurologic intensive care, neuroradiology, functional exploration, neuropathology, neuro-ophthalmology, otoneurology, maxillofacial surgery, neuro-endocrinology and spine surgery. Technical and methodological aspects are also taken onboard: diagnostic and therapeutic techniques, methods for assessing results, epidemiology, surgical, interventional and radiological techniques, simulations and pathophysiological hypotheses, and educational tools. The editorial board may refuse submissions that fail to meet the journal''s aims and scope; such studies will not be peer-reviewed, and the editor in chief will promptly inform the corresponding author, so as not to delay submission to a more suitable journal. With a view to attracting an international audience of both readers and writers, Neurochirurgie especially welcomes articles in English, and gives priority to original studies. Other kinds of article - reviews, case reports, technical notes and meta-analyses - are equally published. Every year, a special edition is dedicated to the topic selected by the French Society of Neurosurgery for its annual report.