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Comment
. 2023 Mar 1;19(2):e53-e54.
doi: 10.1097/PTS.0000000000001075. Epub 2022 Sep 28.

Spinal Cord Stimulator Complications Reported to the Australian Therapeutic Goods Administration

Richard Sullivan, Marc Russo, Nathan Taylor, Danielle Santarelli
Comment

Spinal Cord Stimulator Complications Reported to the Australian Therapeutic Goods Administration

Richard Sullivan et al. J Patient Saf. .
No abstract available

PubMed Disclaimer

Conflict of interest statement

R.S. discloses research agreements with Abbott, Medtronic, and Biotronik (paid to nonprofit research organization), and honoraria received for teaching and training from Medtronic and Abbott. He is the Regional Director Asia and Pacific for the International Neuromodulation Society, past President of the Neuromodulation Society of Australia and New Zealand, and on the Board of Examiners, Faculty of Pain Medicine, ANZCA. M.R. is the President of the International Neuromodulation Society and Director at Large of the Neuromodulation Society of Australia and New Zealand. He discloses research activities (paid to research institution) for Boston Scientific, Mainstay Medical, Medtronic, Nevro, Presidio Medical and Saluda Medical, historical equity interest in Stimwave, Lungpacer and SPR Therapeutics, and stock options in Saluda Medical and Presidio Medical. N.T. discloses consulting fees for Saluda Medical and honoraria received for speakers bureau/teaching from Abbott. D.S. discloses no conflict of interest.

Comment in

  • Author Response.
    Jones CMP, Abdel Shaheed C, Ferreira G, Mannix L, Harris IA, Buchbinder R, Maher CG. Jones CMP, et al. J Patient Saf. 2023 Mar 1;19(2):e55. doi: 10.1097/PTS.0000000000001099. Epub 2022 Dec 19. J Patient Saf. 2023. PMID: 36538290 No abstract available.

Comment on

References

    1. Jones CMP, Shaheed CA, Ferreira G, et al. Spinal cord stimulators: an analysis of the adverse events reported to the Australian Therapeutic Goods Administration. J Patient Saf . 2022;18:507–511.
    1. Deer TR, Mekhail N, Provenzano D, et al. The appropriate use of neurostimulation: avoidance and treatment of complications of neurostimulation therapies for the treatment of chronic pain. Neuromodulation Appropriateness Consensus Committee. Neuromodulation . 2014;17:571–597; discussion 97-8.
    1. Guidance: Safety Monitoring and Reporting in Clinical Trials Involving Therapeutic Goods . Canberra, Australia: National Health and Medical Research Council; 2016. Available at: https://www.nhmrc.gov.au/guidelines-publications/eh59 . Accessed June 28, 2022.
    1. Common Terminology Criteria for Adverse Events (CTCAE). Version 5.0: National Institutes of Health . Bethesda, MD: National Cancer Institute; 2017. Available at: https://ctep.cancer.gov/protocolDevelopment/electronic_applications/ctc.htm . Accessed June 28, 2022.
    1. Deer TR, Provenzano DA, Hanes M, et al. The Neurostimulation Appropriateness Consensus Committee (NACC) recommendations for infection prevention and management. Neuromodulation . 2017;20:31–50.

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