![]() 2 Their use for the last 3 indications is not common in Australia. 2–4 They are commonly used for intractable back pain such as failed back surgery syndrome but are also used to treat other painful conditions including complex regional pain syndrome, angina, ischemic leg pain, and peripheral neuropathy. 1 They are promoted as providing long-term pain relief, particularly when other interventions including surgery have failed. 1 The impulses interfere with how nociceptive signals are interpreted by the brain. Spinal cord stimulators are devices implanted under the skin, which deliver electric impulses via leads placed in the epidural space. In view of the low certainty evidence of their long-term safety and effectiveness, our results raise questions about their role in providing long-term management of intractable pain. Spinal cords stimulators have the potential for serious harm, and each year in Australia, many are removed. The ratio of removals to implants was 4 per every 10 implanted. The most common action taken in response to an adverse event was surgical intervention with or without antibiotics (80%). Device malfunction was the most common event (56.5%). Most events were rated as severe (79%) or life-threatening (13%). Resultsįive hundred twenty adverse events were reported for spinal cord stimulators. Data on the number of stimulators implanted and removed were sourced from the Admitted Patient Care Minimum Data Set. MethodsĪdverse events were coded by seriousness, severity, body system affected, type of event, action taken, and attribution of fault. The aim of the study was to describe the adverse events relating to spinal cord stimulators reported to the Therapeutic Goods Administration of Australia between July 2012 and January 2019. Placebo-controlled trials of spinal cord stimulators typically involve short-term treatment and follow-up, so long-term safety and efficacy are unclear. Spinal cord stimulators are used to treat intractable pain. The work cannot be changed in any way or used commercially without permission from the journal. Direct URL citations appear in the printed text and are provided in the HTML and PDF versions of this article on the journal’s Web site ( This is an open-access article distributed under the terms of the Creative Commons Attribution-Non Commercial-No Derivatives License 4.0 (CCBY-NC-ND), where it is permissible to download and share the work provided it is properly cited. Supplemental digital contents are available for this article. The authors disclose no conflict of interest. Jones, Institute for Musculoskeletal Health/The University of Sydney, Level 10 KGV Bldg, Missenden Rd, Camperdown, NSW 2050, Australia (e-mail: ). ∥Monash Department of Clinical Epidemiology, Cabrini Institute, Malvern, Australia.Ĭorrespondence: Caitlin M. §Clinical Epidemiology, Monash University, Clayton ‡Orthopaedic Surgery, Ingham Institute for Applied Medical Research, South Western Sydney Clinical School, UNSW Sydney, Sydney From the ∗Institute for Musculoskeletal Health/The University of Sydney
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