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

Goel, Vasudha; Yan, Yang; Kanwar, Siddak S.; Banik, Ratan K.; Patwardhan, Amol; Ibrahim, Mohab; Sivanesan, Eellan; Shankar, Hariharan

doi:10.1111/ner.13325

Cited by 17 publications

(14 citation statements)

References 21 publications

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“…This reinforces our argument that it is not generalizable. Our study evaluating AEs associated with intrathecal drug delivery system (IDDS) among chronic pain patients was performed using the Food and Drug Administration's Manufacturer and User Facility Device Experience (MAUDE) database (1). IDDS devices can only be identified using the brand, model, and manufacturer names in the MAUDE database.…”

Section: To the Editorsmentioning

confidence: 99%

Response to Letter to the Editor Regarding: “Adverse Events and Complications Associated With Intrathecal Drug Delivery Systems: Insights From the Manufacturer and User Facility Device Experience (MAUDE) Database”

Goel

Shankar²

2021

Neuromodulation: Technology at the Neural Interface

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Section: To the Editorsmentioning

confidence: 99%

Response to Letter to the Editor Regarding: “Adverse Events and Complications Associated With Intrathecal Drug Delivery Systems: Insights From the Manufacturer and User Facility Device Experience (MAUDE) Database”

Goel

Shankar²

2021

Neuromodulation: Technology at the Neural Interface

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“…For instance, Stetkarova et al calculated a mean complication rate of 0.41 per implant, with catheter malfunctions as the most frequently reported cause (66%) and 7% pump‐related complications 2 . Malfunctions of the IDDS device can lead to overdose or withdrawal 3–5 …”

Section: Introductionmentioning

confidence: 99%

Loss of effectiveness with an implanted drug delivery system for intrathecal pain therapy due to corrosion

Reining

Kretzschmar

2022

Pain Practice

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Introduction: Intrathecal drug delivery is an established invasive treatment option. Most common complication is catheter malfunction, which can lead to overdose or withdrawal. Case Presentation: A 61-year-old female patient underwent an elective replacement of an intrathecal drug delivery pump. The patient complained about a loss of effectiveness over the past 2 years. Intraoperatively, a white mass corresponding to morphine precipitation in the pump pocket was found, which appeared to be due to corrosion at the pump-catheter connection site. Conclusions: Recommendations on how to deal with the decreasing effectiveness of intrathecal drug delivery and on intraoperative catheter handling are provided. K E Y W O R D S corrosion, implantable infusion pumps, intrathecal drug delivery system, opioid analgesicsHow to cite this article: Reining M, Kretzschmar M. Loss of effectiveness with an implanted drug delivery system for intrathecal pain therapy due to corrosion.

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“…The intrathecal drug delivery system (IDDS) is a safe and cost-effective therapeutic choice to treat those patients with chronic pain who have failed to show improvement with less invasive interventions [ 3 - 5 ]. Although relatively rare, IDDS complications occur and are attributed to intrathecal pump (ITP) and catheter malfunctions [ 6 , 7 ]. Catheter malfunctions include granuloma formation at the tip, migration of the tip, tear, inadvertent puncture, and connection loosening [ 6 , 8 ].…”

Section: Introductionmentioning

confidence: 99%

Pre- and Post-Interventional Changes in Physiological Profiles in a Patient Presenting With Opioid Withdrawal After Intrathecal Drug Delivery System Failure Related to Assumed Catheter Microfracture

Ehsanian¹,

Koshkin²,

Goins³

et al. 2021

Cureus

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The intrathecal drug delivery system (IDDS) is successfully utilized for the treatment of chronic pain conditions; however, they are associated with complications related to human error and system failure. A case report is presented of a patient with opioid withdrawal (OW) secondary to assumed catheter microfracture. Interrogation of the IDDS allowed for the collection of pre-and post-treatment/stabilization cerebrospinal fluid (CSF), which is used to investigate the possible physiological determinants of OW.A 46-year-old female with a history of low back pain after traumatic low back injury status post-IDDS placement for failed back surgery syndrome presented with signs and symptoms concerning for OW. After every other possible explanation was ruled out, it was hypothesized that there may be IDDS catheter microfracture(s), and catheter replacement led to symptom resolution. There were no significant differences in cytokine levels tested in pre-CSF versus post-CSF samples. Whole-cell patch-clamp electrophysiology analysis of human-induced pluripotent stem cell-derived nociceptors after treatment with pre-and post-CSF samples demonstrated modulation of action potential waveform.In patients presenting with acute OW attribution IDDS malfunction, catheter microfracture must be in the differential, and non-conventional interrogation of the IDDS catheter should be considered. The possible differences in pre-CSF and post-CSF may be more complicated than previously postulated, as there were no significant differences in cytokine profiles; however, treatment of in vitro neurons with pre-and post-CSF resulted in differential neuronal excitability, which may account for some of the symptoms of OW.

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

Cited by 17 publications

References 21 publications

Response to Letter to the Editor Regarding: “Adverse Events and Complications Associated With Intrathecal Drug Delivery Systems: Insights From the Manufacturer and User Facility Device Experience (MAUDE) Database”

Response to Letter to the Editor Regarding: “Adverse Events and Complications Associated With Intrathecal Drug Delivery Systems: Insights From the Manufacturer and User Facility Device Experience (MAUDE) Database”

Loss of effectiveness with an implanted drug delivery system for intrathecal pain therapy due to corrosion

Pre- and Post-Interventional Changes in Physiological Profiles in a Patient Presenting With Opioid Withdrawal After Intrathecal Drug Delivery System Failure Related to Assumed Catheter Microfracture

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