Medtronic. Lead Kit for Deep Brain Stimulation Implant Manual, Models 3387 and 3389 (Rx Only). Medtronic; publication information in PDF. https://trajectoryguide.greydongilmore.com/static/medtronic_lead_3387_3389_implant_manual_2008.pdf
US Food and Drug Administration. Summary of Safety and Effectiveness Data (SSED): Medtronic Activa Parkinson’s Control Therapy, including Models 3387/3389 DBS Leads. March 31, 2000. https://www.accessdata.fda.gov/cdrh_docs/pdf/p960009s007b.pdf
Rahimpour S, Khajavi K, Razavi S, et al. Deep brain stimulation and electromagnetic interference. Front Hum Neurosci. 2021;15:665475. doi:10.3389/fnhum.2021.665475. PMCID: PMC8081063. https://pmc.ncbi.nlm.nih.gov/articles/PMC8081063/
Schüpbach WMM, Chabardes S, Matthies C, Pollo C, Steigerwald F, Timmermann L, Volkmann J. Directional leads for deep brain stimulation: Opportunities and challenges. Mov Disord. 2017;32(10):1371-1375. doi:10.1002/mds.27096. PMID: 28843016. https://pubmed.ncbi.nlm.nih.gov/28843016/
Steigerwald F, Matthies C, Volkmann J. Directional deep brain stimulation. Neurotherapeutics. 2019;16(1):100-104. doi:10.1007/s13311-018-0667-7. https://www.sciencedirect.com/science/article/pii/S1878747923009996
Paff M, Chang P, Bankiewicz K, et al. Update on current technologies for deep brain stimulation in Parkinson’s disease. J Mov Disord. 2020;13(3):185-198. https://www.e-jmd.org/journal/view.php?number=302
Butson CR, McIntyre CC. Current steering to control the volume of tissue activated during deep brain stimulation. Brain Stimul. 2008;1(1):7-15. PMID: 19142235. https://pubmed.ncbi.nlm.nih.gov/19142235/
Butson CR, McIntyre CC. Role of electrode design on the volume of tissue activated during deep brain stimulation. J Neural Eng. 2006;3(1):1-8. doi:10.1088/1741-2560/3/1/001. PMID: 16510937. PMCID: PMC2583360. https://pubmed.ncbi.nlm.nih.gov/16510937/
Butson CR, Cooper SE, Henderson JM, McIntyre CC. Patient-specific analysis of the volume of tissue activated during deep brain stimulation. NeuroImage. 2007;34(2):661-670. doi:10.1016/j.neuroimage.2006.09.034. PMID: 17113789. https://pubmed.ncbi.nlm.nih.gov/17113789/
Patrick EE, Lujan JL, Kent AR, et al. Modeling the volume of tissue activated in deep brain stimulation: A review. Front Hum Neurosci. 2024;18:1333183. doi:10.3389/fnhum.2024.1333183. https://www.frontiersin.org/journals/human-neuroscience/articles/10.3389/fnhum.2024.1333183/full
Satzer D, Lanctin D, Eberly L, et al. Variation in deep brain stimulation electrode impedance over years following electrode implantation. Stereotact Funct Neurosurg. 2014;92(2):94-102. PMCID: PMC4531050. https://pmc.ncbi.nlm.nih.gov/articles/PMC4531050/
Lempka SF, Miocinovic S, Johnson MD, et al. In vivo impedance spectroscopy of deep brain stimulation electrodes. J Neural Eng. 2009;6(4):046001. PMCID: PMC2861504. https://pmc.ncbi.nlm.nih.gov/articles/PMC2861504/
Shukla AW, Okun MS. DBS programming: An evolving approach for patients with Parkinson’s disease. Neurol Ther. 2017;6(Suppl 1):S85-S99. PMCID: PMC5632902. https://pmc.ncbi.nlm.nih.gov/articles/PMC5632902/
Deeb W, Patel A, Okun MS, Gunduz A. Management of elevated therapeutic impedances on deep brain stimulation leads. Tremor Other Hyperkinet Mov (N Y). 2017;7:493. doi:10.5334/tohm.370. PMCID: PMC5628334. https://pmc.ncbi.nlm.nih.gov/articles/PMC5628334/
US Food and Drug Administration. Clinician Programmer Application for Deep Brain Stimulation. February 14, 2025. https://www.accessdata.fda.gov/cdrh_docs/pdf/P960009S478C.pdf
Morishita T, Hilliard JD, Okun MS, Neal D, Nestor KA, Peace D, et al. Postoperative lead migration in deep brain stimulation surgery: Incidence, risk factors, and clinical impact. PLoS One. 2017;12(9):e0183711. doi:10.1371/journal.pone.0183711. PMCID: PMC5597118. https://pmc.ncbi.nlm.nih.gov/articles/PMC5597118/
Dormont D, Cornu P, Pidoux B, et al. Neuroimaging and deep brain stimulation. AJNR Am J Neuroradiol. 2010;31(1):15-23. https://www.ajnr.org/content/31/1/15
Fernández FS, Seijo FJ, Alvarez Vega MA, et al. Lead fractures in deep brain stimulation during long-term follow-up. Stereotact Funct Neurosurg. 2010;88(2):131-137. PMCID: PMC2957221. https://pmc.ncbi.nlm.nih.gov/articles/PMC2957221/
De Vloo P, De Bruin N, et al. Open fracture of deep brain stimulation leads with normal-range electrical impedances: Case report and review. Brain Stimul. 2020. https://www.sciencedirect.com/science/article/pii/S1935861X20302576
Nurimanov C, et al. Managing lead fractures in deep brain stimulation: Clinical patterns and diagnostic approach. J Clin Med. 2024;13(24):7509. https://www.mdpi.com/2077-0383/13/24/7509
Reinacher PC, Krüger MT, Coenen VA, et al. Determining the orientation of directional deep brain stimulation electrodes using postoperative imaging. AJNR Am J Neuroradiol. 2017;38(6):1111-1116. https://www.ajnr.org/content/38/6/1111
Medtronic. SenSight Directional Lead Kit (Models B33005, B33015) Implant Manual. https://trajectoryguide.greydongilmore.com/static/medtronic_sensight_B33005_B33015_manual_2021.pdf
Boston Scientific. Vercise Deep Brain Stimulation Systems Surgical Implant Manual. Document 92328632-05B. https://www.bostonscientific.com/content/dam/elabeling/nm/92328632-05B_DBS_Surgical_Implant_Manual_US_EN_s.pdf
Abbott. Abbott Medical Infinity DBS System, lead specifications (document hosted on Regulations.gov). January 2, 2020. https://downloads.regulations.gov/FDA-2020-M-0097-0001/attachment_1.pdf
European Medicines Agency. Medical devices, overview of CE marking and conformity assessment. Updated December 10, 2025. https://www.ema.europa.eu/en/human-regulatory-overview/medical-devices
UK Government. Regulating medical devices in the UK. https://www.gov.uk/guidance/regulating-medical-devices-in-the-uk
Therapeutic Goods Administration (Australia). Reclassifying active implantable medical devices (AIMD). Updated April 1, 2021. https://www.tga.gov.au/resources/guidance/reclassifying-active-implantable-medical-devices-aimd
Health Canada. Regulatory Decision Summary, Deep Brain Stimulation (DBS) Leads (device licensing summary). https://hpr-rps.hres.ca/reg-content/regulatory-decision-summary-medical-device-detail.php?linkID=RDS14676