Adverse Events and Complications Associated With Intrathecal Drug Delivery Systems: Insights From the Manufacturer and User Facility Device Experience (MAUDE) Database. Issue 7 (11th December 2020)

• Record Type: Journal Article
• Authors: Goel, Vasudha; Yang, Yan; Kanwar, Siddak; Banik, Ratan K.; Patwardhan, Amol M.; Ibrahim, Mohab; Sivanesan, Eellan; Shankar, Hariharan
• Is Part Of: Neuromodulaton. Volume 24:Issue 7(2021)
• Page Start: 1181
• Page End: 1189
• Publication Date: 2020-12-11
• Subjects: Chronic pain -- complications -- FDA -- implantable devices -- intrathecal drug delivery system; Central nervous system -- Physiology -- Periodicals; Central nervous system -- Diseases -- Periodicals; 616.8
• DOI: 10.1111/ner.13325
• Languages: English
• ISSNs: 1094-7159

Abstract

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 six months till August 2020 to evaluate for any additional reported cases during the index months. The two FDA approved IDDS, were included. AE were broadly classified into causes related to catheter malfunction, pump malfunction, biologic, and medication‐related AE. Results: A total of 1001 reports were included in the final analysis. The top three reasons for adverse report are infection/erosion (15.7%, n = 157), motor stall (12.4%, n = 125) and adverse medication reactions (11.8%, n = 119), respectively. There were five deaths among patients with IDDS. Epidural hematoma ( n = 3) after IDDS surgery resulted in a death and residual neurological deficits after surgical evacuation. Programming errors, medication concentration discrepancy, and failure to turn on the pump after reprogramming are various preventable causes of medication‐related IDDS AEs. Conclusions: Analysis of AE associated with IDDS from the MAUDE database provided a real‐world perspective different from reported registry complications. Awareness and vigilance of preventable IDDS‐related complications is the first step toward mitigating risks to provide safe and effective intrathecal drug delivery for chronic pain management.