Adverse Events and Complications Associated With Intrathecal Drug Delivery Systems: Insights From the Manufacturer and User Facility Device Experience (MAUDE) Database.

ABSTRACT:

Background

Modern intrathecal drug delivery systems (IDDS) are technologically advanced to deliver medication through various automated and patient-controlled programs. They also are associated with unique complications ranging from post-operative complications, medication-related adverse events (AE), device malfunction, to refill associated AE.

Objectives

To systematically analyze real-world complications and AE reported on the Food and Drug Administration's Manufacturer and User Facility Device Experience database (MAUDE) associated with IDDS among patients predominantly with chronic pain disorders.

Materials and methods

MAUDE database was sampled for a month four times a year during the study period, February 2018 to February 2019. The database was resampled every

SUBMITTER: Goel V 

PROVIDER: S-EPMC9034464 | biostudies-literature | 2021 Oct

REPOSITORIES: biostudies-literature