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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