WaveWriter Alpha™ and WaveWriter Alpha™ Prime Systems Information for Prescribers 92395224-01 Content: MP92395224-01 REV A CAUTION: Federal law restricts this device to sale, distribution and use by or on the order of a physician.
Information for Prescribers Guarantees Boston Scientific Corporation reserves the right to modify, without prior notice, information relating to its products in order to improve their reliability or operating capacity. Drawings are for illustration purposes only. Trademarks Wavewriter Alpha™ and Wavewriter Alpha™ Prime are registered trademarks of Boston Scientific Corporation or its affiliates. All other trademarks are the property of their respective owners.
Table of Contents Device and Product Description....................................................................1 Essential Performance....................................................................................1 System Clinical Summary .............................................................................1 Subperception Therapy - Clinical Summary.................................................5 Contraindications.........................................................................
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Device and Product Description Device and Product Description The WaveWriter Alpha™ and WaveWriter Alpha™ Prime Systems consist of an Implantable Pulse Generator (IPG), temporary and permanent Percutaneous Leads, Surgical Paddle Leads, Lead Extensions, OR Cables, External Trial Stimulator (ETS), Remote Control, and Clinician Programmer, each packaged as a separate kit. Single use accessories and disposable tools are also included in these kits.
Information for Prescribers diagnostic or therapeutic intervention for the same disease/conditions and patient population as the WaveWriter Alpha and WaveWriter Alpha Prime Systems. 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.
System Clinical Summary In this study, 7 (17%) patients suffered complications after implantation of the device; 5 (12%) patients required repositioning of catheter type electrodes and 2 patients required revision of the stimulator generator. Safety Evaluation Eleven studies were identified based on the detailed inclusion/exclusion criteria to demonstrate the safety of the WaveWriter Alpha and WaveWriter Alpha Prime Systems.
Information for Prescribers Table 2: Clinical Experience Safety Type Number of Patients Resolution Lead Migration 1 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.
Subperception Therapy - Clinical Summary Subperception Therapy - Clinical Summary Determination of the safety and effectiveness of the Boston Scientific Spinal Cord Stimulator (SCS) Systems for subperception therapy was based on a prospective, randomized, multicenter, crossover study with the primary endpoint of responder rate (proportion of subjects with 50% or greater improvement in overall pain) at 3 month post-device activation.
Information for Prescribers Instructions for the Patient Warnings Heat Due to Charging (for rechargeable IPGs). Patients should not charge while sleeping. This may result in a burn. While charging, the Charger may become warm. It should be handled with care. Failure to use the Charger with either the Charging Belt or an adhesive patch, may result in a burn. If patients experience pain or discomfort, they should cease charging and contact Boston Scientific. Magnetic Resonance Imaging (MRI).
Safety Information • • • • • • • • Theft detectors, tag deactivators and RFID devices, such as those used at department stores, libraries, and other public establishments: Patients should proceed with caution, ensuring that they move through the center of the detector as quickly as possible. Interference from these devices should not cause permanent damage to the implanted device.
Information for Prescribers Automobiles and Other Equipment. Patients using therapy that generates paresthesia should not operate motorized vehicles such as automobiles or potentially dangerous machinery and equipment with the stimulation on. Stimulation must be turned off first in such cases. For these patients, any sudden stimulation changes may distract patients from proper operation of the vehicle, machinery, or equipment. For therapy that does not generate paresthesia (e.e.
Safety Information Handle the system external components and accessories with care. Do not drop them or submerge them in water. Although reliability testing has been performed to ensure quality manufacturing and performance, dropping the devices on hard surfaces or in water, or other rough handling, can permanently damage these components. (See “Limited Warranty - IPG”.) Upon completion of the Patient Trial, remove the batteries from the ETS. Component Disposal.
Information for Prescribers • Exposure to magnetic resonance imaging (MRI) can result in discomfort or injury due to heat near the Stimulator or the leads, tugging or vibration of the implanted system, induced stimulation, damage to the device requiring its replacement, and may distort the image needed for diagnosis. • Undesirable stimulation may occur over time due to cellular changes in tissue around the electrodes, changes in electrode position, loose electrical connections and/or lead failure.
Safety Information When a user initiates a communication session, the system will typically respond in 1 to 6 seconds. The typical data throughput during active programming session will be more than 10 kbs. Troubleshooting Wireless Coexistence Issues Other wireless and RF technology based equipments operating in the close proximity that uses similar frequency band may degrade the range and responsiveness of the System.
Information for Prescribers Boston Scientific has developed a process to receive potential product security vulnerabilities from external sources in order to validate their existence and determine how to best respond to improve product security and safety. Please refer to the following webpage to report potential product security vulnerabilities to the Boston Scientific Product Security team: https://www.bostonscientific.com/en-US/customer-service/product-security/responsible-disclosure.
Safety Information Guidance and manufacturer’s declaration – electromagnetic immunity The WaveWriter Alpha and WaveWriter Alpha Prime Systems are intended for use in the electromagnetic environment specified below. The customer or the user of the WaveWriter Alpha or WaveWriter Alpha Prime System should assure that it is used in such an environment.
Information for Prescribers NOTE These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy.
Safety Information IEC 61000-4-3 1720 MHz, 1845 MHz, 1970 MHz: 28 V/m @ 217 Hz pulse modulation 28 V/m 2450 MHz: 28 V/m @ 217 Hz pulse modulation 28 V/m 5240 MHz, 5500 MHz, 5785 MHz: 9 V/m @ 217 Hz pulse modulation 9 V/m Recommended separation distance d = 30 cm NOTE: For the frequency bands in this table, use the specified recommended separation distance.
Information for Prescribers Sterilization All implantable and surgical components of the WaveWriter Alpha and WaveWriter Alpha Prime Systems, 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.
FCC Rules FCC Rules The following is federal government communications regulation information about the WaveWriter Alpha and WaveWriter Alpha Prime 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 WaveWriter Alpha and WaveWriter Alpha Prime Systems use a software programs the IPG to end service after 12 years.
End of Programmed Service IPG Battery Life Rechargeable Systems The rechargeable battery in the WaveWriter Alpha System IPG should provide at least five years of service.1 Battery life is dependent on your stimulation settings and conditions. In most cases, the Stimulator will need to be recharged at intervals ranging from once a week to once a month. Over time, the IPG battery will need more frequent recharges.
Information for Prescribers Longevity, Years Longevity, Years identify the longevity that corresponds to this Energy Use Index. Figures 1 and 2 take into account nominal non-therapy power consumption, including shelf-life and patient remote control use. If the estimate for longevity obtained by these Figures is below 12 months, consider evaluating a Boston Scientific rechargeable system.
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Legal Manufacturer Boston Scientific Neuromodulation Corporation 25155 Rye Canyon Loop Valencia, CA 91355 USA (866) 789-5899 in US and Canada (661) 949-4000, (661) 949-4022 Fax (866) 789-6364 TTY www.bostonscientific.com Email: neuro.info@bsci.
