ArticleNeuromodulation : journal of the International Neuromodulation Society2021
Adverse Events and Complications Associated With Intrathecal Drug Delivery Systems: Insights From the Manufacturer and User Facility Device Experience (MAUDE) Database.
Article in Neuromodulation : journal of the International Neuromodulation Society, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers.
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Who cites it
13 citing papers in PubMed, 29 citations in OpenAlex.
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- Outcomes of Low Back Placement of Intrathecal Pumps for Patients with Chronic Pain.Pain and therapy · 2026Article
- Troubleshooting intrathecal pumps in pain management: A clinical review.Interventional pain medicine · 2026Review
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- Pharmacovigilance in Cell and Gene Therapy: Evolving Challenges in Risk Management and Long-Term Follow-Up.Drug safety · 2026Review
- Ensuring the Safety of MRI Patients With Medical Implants or Devices In Situ: A Snapshot in Time of the Role and Responsibilities of New Zealand and Australian MRI Technologists (Radiographers).Journal of medical radiation sciences · 2025Article
- The pharmacotherapeutic potential of neuropeptide Y for chronic pain.Journal of internal medicine · 2025Review
- Intrathecal drug delivery systems: A case series advancing surgical, clinical, and technological safety with broader implications for invasive neuromodulation therapies.SAGE open medical case reports · 2025Article
- Intrathecal Immunoselective Nanopheresis for Alzheimer's Disease: What and How? Why and When?International journal of molecular sciences · 2024Review
- Strategies for enhanced gene delivery to the central nervous system.Nanoscale advances · 2024Review
- Phase I Safety and Feasibility Pilot of Hepatic Artery Infusion Chemotherapy in a Rural Catchment Area Using The Codman Vascular Catheter with The Medtronic SynchroMed II Pump for Intrahepatic Cancers.Annals of surgical oncology · 2024Article
- The American Society of Pain and Neuroscience (ASPN) Evidence-Based Clinical Guideline of Interventional Treatments for Low Back Pain.Journal of pain research · 2022Review
- Article
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Authors and funding
8 authors at 5 institutions in 1 country.
Funding
Abstract
backgroundModern 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.
objectivesTo 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
methodsMAUDE 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.
resultsA 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.
conclusionsAnalysis 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.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.