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Incidence and Avoidance of Neurologic Complications with Paddle Type Spinal Cord Stimulation Leads
Version of Record online: 3 OCT 2011
© 2011 International Neuromodulation Society
Neuromodulation: Technology at the Neural Interface
Volume 14, Issue 5, pages 412–422, September/October 2011
How to Cite
Levy, R., Henderson, J., Slavin, K., Simpson, B. A., Barolat, G., Shipley, J. and North, R. (2011), Incidence and Avoidance of Neurologic Complications with Paddle Type Spinal Cord Stimulation Leads. Neuromodulation: Technology at the Neural Interface, 14: 412–422. doi: 10.1111/j.1525-1403.2011.00395.x
Conflict of Interest: Dr. Levy consults for Medtronic, Spinal Modulation, Vertos, Boston Scientific, St. Jude Medical, Bioness, NuCurrent, and Codman & Shurtleff. Dr. Henderson has served as a consultant (paid) for NDI Medical, Johnson & Johnson (paid), and Proteus Biomedical (stock options). He serves on the Scientific Advisory Board of Nevro Corporation (stock options). He previously served on the Scientific Advisory Board of Intelect Medical (stock options, royalties), which was recently sold to Boston Scientific. He has received teaching honoraria from Medtronic, Inc. He has received research funding from the Michael J. Fox Foundation, the Davis Phinney Foundation, the John A. Blume Foundation, the Wallace Coulter Foundation, the Beckman Foundation, the Bob and Ruth Halperin Foundation, the Stanford Institute for Neuro-Innovation and Translational Neuroscience, and the National Institutes of Health. He is in negotiation with Boston Scientific for a consulting contract. Dr. Slavin is a paid consultant and has received honoraria, consulting fees, and/or research support from the following companies: St. Jude Medical; Medtronic; Boston Scientific; Bioness; Greatbatch. Mr. Simpson gave a talk last year, which was sponsored by St. Jude Medical, but the fee was paid to his department. Dr. Barolat is a consultant for Medtronic and St. Jude Medical and a Consultant/equity owner of QIG group. Ms. Shipley's employer (The Neuromodulation Foundation) has consulting agreements with and unrestricted educational grants from the companies that manufacture SCS equipment. Dr. North's current (Sinai Hospital of Baltimore) and former employers (Johns Hopkins University) received funding from industry (Boston Scientific, Inc.; Medtronic, Inc.; St. Jude Medical, Inc.) as does the non-profit Neuromodulation Foundation, of which he is an unpaid officer. He has consulting/equity interest in Algostim LLC.
- Issue online: 3 OCT 2011
- Version of Record online: 3 OCT 2011
- Received: June 10, 2011 Revised: June 29, 2011 Accepted: June 30, 2011
- Paddle lead;
- neurologic complications;
- epidural hematoma
Introduction: While reference is frequently made to the risk of spinal cord or nerve root injury with the surgical implantation of paddle type spinal cord stimulation (SCS) electrodes, data are lacking on the frequency, causes, and prevention of these complications.
Methods: To determine the incidence and frequency of neurologic complications, we performed 1) a comprehensive analysis of the literature to determine the incidence of complications that have caused or could lead to neurologic injury; 2) an analysis of the US Food and Drug Administration Manufacturer and User Facility Device Experience (MAUDE) data base; and 3) an investigation of manufacturers' data on surgically implanted paddle electrodes. We then convened an expert panel of neurosurgeons experienced in the surgical implantation of paddle electrodes to provide recommendations to minimize the risk of neurologic injury.
Results: The scientific literature describes the breadth of neurologic complications that can result from SCS electrode implantation but does not provide interpretable data with respect to the incidence and frequency of these complications. The MAUDE data base is not constructed to be sensitive or specific enough to provide these critical data. Primary data show a risk of neurologic injury from implantation of paddle electrodes below 0.6%.
Discussion: Preoperative, intraoperative, and postoperative measures to further minimize this risk are described.
Conclusions: This investigation, the first comprehensive evaluation of the incidence and frequency of neurologic injury as a result of SCS paddle electrode implantation, suggests that neurologic injury is a rare, but serious, complication of SCS. The incidence of these complications should be decreased by the adoption of approaches that improve procedural safety and by careful patient follow-up and complication management. Physicians should be aware of these approaches and take every precaution to reduce the risk of neurologic injury. Physicians also should report any adverse event leading to injury or death and work together to improve access to these data.