Precision Spectra™ System Information for Prescribers CAUTION: Federal law restricts this device to sale, distribution and use by or on the order of a physician.
Information for Prescribers Copyright © 2012 Boston Scientific Corporation or its affiliates. All Rights Reserved. These documents are the property of Boston Scientific Corporation and shall not be reproduced, distributed, disclosed, or used for manufacture or sale of device without the express written consent of Boston Scientific Corporation.
Table of Contents Table of Contents Device and Product Description .................................................................. 1 Precision Spectra System Clinical Summary........................................................ 1 Contraindications ........................................................................................... 6 Safety Information .......................................................................................... 6 Instructions for the Patient ......................
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Device and Product Description Device and Product Description The Precision Spectra™ Spinal Cord Stimulation System consists of an Implantable Pulse Generator (IPG), temporary and permanent Percutaneous Leads, Surgical Paddle Leads, Lead Extensions, OR Cables, Trial Stimulator, Remote Control, Clinician Programmer, and Programming Wand, each packaged as a separate kit. Single use accessories and disposable tools are also included in these kits.
Information for Prescribers The prospective study by Ohnmeiss et al. 1996, examined the long-term effectiveness of SCS in patients with intractable leg pain. Forty patients were implanted with SCS systems and evaluated at 6 weeks, 12 months, and 24 months follow-up. Outcome measures included the VAS, pain drawings, medication use, SIP (Sickness Impact Profile), isometric lower extremity testing, and patient questionnaires. An intent-to-treat analysis was performed.
Precision Spectra System Clinical Summary treatment reduced the pain by 50%, the systems were internalized. A retrospective analysis of patients with unilateral leg and/or buttock pain treated initially with SCS and bilateral leg or mainly low back pain treated initially with spinal infusions of opioids was then done. In this study, 42 patients were screened; 26 (62%) patients received spinal stimulation; 16 (38%) received opioids via a spinal infusion pump.
Information for Prescribers Table 1: Summary of Risks Identified in the Retrospective Clinical Studies Risks Lead Migration Infection # Patients With Adverse Event 175 39 Intent-to-Treat Basis N = 1056 16.6% 3.7% Implanted Patient Basis N = 880 19.9% 4.4% Epidural Hemorrhage Seroma Hematoma Paralysis CSF Leak Over/Under Stimulation, Ineffective Pain Control Intermittent Stimulation Pain Over Implant 0 0 1 0 5 46 0% 0% 0.1% 0% 0.5% 4.4% 0% 0% 0.1% 0% 0.6% 5.2% 0 16 0% 1.5% 0% 1.
Precision Spectra System Clinical Summary Table 2: Clinical Experience Safety Type Lead Migration Number of Patients 1 Resolution Lead repositioning and subsequent replacement Output malfunction 1 Device replaced Infection Pain 1 1 Infection treated Lead explanted Other minor adverse events reported by at least one patient included: receiver malfunction, skin irritation, unpleasant stimulation, CSF leak, infection at implant site, lead migration, and OR cable malfunction.
Information for Prescribers Rainov, N.G., V. Heidecke, and W. Burkert. “Short Test-Period Spinal CordStimulation for Failed Back Surgery Syndrome.” Minim Invasive Neurosurg, 39(2):41-44, 1996. Segal, R., B. Stacey, T. Rudy, S. Basser, J. Markham. “Spinal Cord Stimulation Revisited.” Neurological Research, 20:391-396, 1998. Spieglemann, R. and W.A. Friedman. “Spinal Cord Stimulation: A Contemporary Series.” Neurosurg 28:65-71, 1991. Villavicencio, A.T., J.C. Leveque, L. Rubin, K. Bulsara, and J.P. Gorecki.
Safety Information Pediatric Use. The safety and effectiveness of spinal cord stimulation has not been established for pediatric use. Diathermy. Shortwave, microwave and/ or therapeutic ultrasound diathermy should not be used on SCS patients. The energy generated by diathermy can be transferred through the Stimulator system, causing tissue damage at the lead site and resulting in severe injury or death. The IPG, whether it is turned on or off, may be damaged. Implanted Stimulation Devices.
Information for Prescribers Precautions Physician training is required. Medical Devices/Therapies. The following medical therapies or procedures may turn stimulation off or may cause permanent damage to the Stimulator, particularly if used in close proximity to the device: • • • • • • lithotripsy electrocautery (See “Instructions for the Physician” on page 11) external defibrillation radiation therapy (Any damage to the device by radiation may not be immediately detectable.
Safety Information Stimulator Location. Patients should never attempt to change the orientation or “flip” (rotate or spin) the Stimulator. Patients should not “finger” or play with the Stimulator. If the Stimulator flips over in the Patient’s body, it cannot be charged. If the Patient knows that the device has turned, or if stimulation cannot be turned on after charging, the Patient should contact his or her physician to arrange an evaluation of the system.
Information for Prescribers Remote Control, Charging System, External Trial Stimulator and Wand Cleaning. The charging system components can be cleaned using alcohol or a mild detergent applied with a cloth or tissue. The Remote Control, External Trial Stimulator and Programming Wand can be cleaned using a mild detergent applied with a lightly dampened cloth or tissue. Residue from soapy detergents should be removed with a cloth lightly dampened with water. Do not use abrasive cleansers for cleaning.
Instructions for the Physician Instructions for the Physician Implanted Stimulation Devices. If such implanted devices are indicated for the patient, careful screening is required to determine if safe results can be achieved before permanently implementing concurrent electrical therapies. Postural Changes. Depending on the activity level of the patient, postural changes may affect stimulation intensity.
Information for Prescribers Sterilization All Precision Spectra™ System implantable and surgical components are sterilized with ethylene oxide. • • • • • • • Inspect the condition of the sterile package before opening the package and using the contents. Do not use the contents if the package is broken or torn, or if contamination is suspected because of a defective sterile package seal. Do not use any component that shows signs of damage. Do not resterilize the package or the contents.
Sterilization FCC Rules The following is federal government communications regulation information about the Precision Spectra™ Spinal Cord Stimulation System. This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) This device must accept any interference received including interference that may cause undesired operation.
Information for Prescribers End of Programmed Service The Precision Spectra™ System IPG software is programmed to end service after 12 years.
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