Department of Neurological Surgery, Rutgers New Jersey Medical School, Newark, New Jersey, USA.
Department of Neurological Surgery, Rutgers New Jersey Medical School, Newark, New Jersey, USA.
World Neurosurg. 2020 Jul;139:e652-e657. doi: 10.1016/j.wneu.2020.04.070. Epub 2020 Apr 24.
Intrathecal baclofen (ITB) is an effective treatment for spasticity, and therapeutic levels may be optimized using surgically implanted pumps. Though these devices are effective, complications can pose significant challenges to patients, decreasing the therapeutic effect and potentially requiring reoperation. As such, it is critical that complications associated with ITB be effectively characterized.
We queried the Manufacturer and User Facility Device Experience (MAUDE) database for cases reported during the past 3 years documenting adverse events specifically related to ITB pumps. We identified 1935 adverse events that were individually analyzed and categorized by type of complication.
Out of the 1935 unique adverse events identified from the MAUDE database, 25.7% were device-related complications (n = 497). Of those, 50.3% were catheter-specific (n = 250), 21.3% (n = 106) were pump-specific, and 28.3% (n = 141) were included, more generally, in catheter or device erosion.
The MAUDE database may be a useful resource for evaluating ITB pump complications across a larger data set. By characterizing the complications and providing values for their total occurrences, patients and physicians may have more realistic expectations for the outcomes and morbidity of this device.
鞘内注射巴氯芬（ITB）是治疗痉挛的有效方法，通过植入的泵可以优化治疗水平。尽管这些设备有效，但并发症可能对患者造成重大挑战，降低治疗效果并可能需要再次手术。因此，有效地描述与 ITB 相关的并发症至关重要。
我们查询了制造商和用户设施设备体验（MAUDE）数据库，以获取过去 3 年中记录的与 ITB 泵相关的不良事件报告。我们确定了 1935 起不良事件，并对其进行了单独分析和分类，按并发症类型进行分类。
从 MAUDE 数据库中确定的 1935 起独特不良事件中，有 25.7%是与设备相关的并发症（n=497）。其中，50.3%是导管特异性的（n=250），21.3%（n=106）是泵特异性的，28.3%（n=141）更笼统地归类为导管或设备侵蚀。
MAUDE 数据库可能是评估更大数据集内 ITB 泵并发症的有用资源。通过对并发症进行特征描述并提供其总发生率的值，患者和医生可能对该设备的结果和发病率有更现实的预期。
