Device And Product Description; Contraindications; Safety Information; Instructions For The Patient - Boston Scientific WaveWriter Alpha Informacion Para Medicos

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.
Note: Surgical Paddle Leads are not approved for use in a Peripheral Nerve Stimulation (PNS) procedure. Information and instructions for Surgical
Paddle Leads do not apply to the Boston Scientific Systems for PNS.
Features of the WaveWriter Alpha and WaveWriter Alpha Prime System include:
• Automatic program cycling
• MicroBurst capability between 0 to 1 second range
• Programming of multi-areas at rates greater than 130 Hz
• Patient-provided Therapy Rating Stimulation electrode field navigation
• Up to thirty-two independent current-controlled electrodes
• Four programmable stimulation areas per program; sixteen possible programs
• Long-life operation
• High-range parameter capability
• Small size and rounded shape
• Wireless programming capabilities
• This product contains no detectable latex

Contraindications

Patients contraindicated for permanent Spinal Cord Stimulator or Peripheral Nerve Stimulation therapy are those who:
• are unable to operate the System
• have failed trial stimulation by failing to receive effective pain relief
• are poor surgical candidates
• are pregnant

Safety Information

WARNING: Unauthorized modification to the medical devices is prohibited. System integrity could be compromised and harm or injury to the patient
could occur if the medical devices are subjected to unauthorized modification.

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, as shown, may
result in a burn. If patients experience pain or discomfort, they should cease charging and contact their healthcare provider or Boston Scientific.
Magnetic Resonance Imaging (MRI) for SCS.
• The WaveWriter Alpha and WaveWriter Alpha Prime SCS Systems are "MR Conditional". An MRI examination can be conducted safely only
when using a 1.5 Tesla horizontal closed-bore whole-body MRI system for the MRI scan and following all instructions in the supplemental manual
"ImageReady™ MRI Full Body Guidelines for WaveWriter Alpha™ and WaveWriter Alpha™ Prime Spinal Cord Stimulator Systems". The 1.5T MRI
system can be configured to use the Full Body, Head, and Extremity transmit/receive RF quadrature coils, and receive only coils of any type. It is
important to read the information in the supplemental manual in its entirety before conducting or recommending an MRI examination on a patient
with a WaveWriter Alpha or WaveWriter Alpha Prime SCS System. The "ImageReady™ MRI Full Body Guidelines for WaveWriter Alpha™ and
WaveWriter Alpha™ Prime Spinal Cord Stimulator Systems" manual appears on the Boston Scientific websites
(www.bostonscientific.com/ImageReady and www.bostonscientific-elabeling.com). MRI examinations performed on patients with the WaveWriter
Alpha or WaveWriter Alpha Prime SCS System using open-sided MRI systems, or other types of MRI systems operating at other static magnetic field
strengths (higher or lower), have not been assessed and, as such, should not be performed.
• External Devices: External components (for example, the ETS, Remote Control, Battery Charger) are MR Unsafe. They must not be taken into
any MR environment such as the MRI scanner.
Magnetic Resonance Imaging (MRI) for Peripheral Nerve Stimulation. MRI-conditional labeling or full-body MRI labeling does not apply to PNS.
Patients implanted with any of the Boston Scientific Systems for PNS should not be subjected to MRI. MRI exposure may result in dislodgement of
implanted components, heating of the neurostimulator, damage to the device electronics and/or voltage induction through the Leads and Stimulator
causing an uncomfortable or "jolting" sensation.
Pediatric Use. The safety and effectiveness of stimulation has not been established for pediatric use.
Diathermy. Shortwave, microwave and/ or therapeutic ultrasound diathermy should not be used on patients with a stimulator. 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. Stimulators may interfere with the operation of implanted sensing stimulators such as pacemakers or cardioverter
defibrillators. The effects of implanted stimulation devices on neurostimulators is unknown.
Stimulator Damage. Burns may result if the pulse generator case is ruptured or pierced and patient tissue is exposed to battery chemicals. Do not
implant the device if the case is damaged.
Postural Changes. Patients should be advised that changes in posture or abrupt movements may cause decreases, or uncomfortable or painful
increases in the perceived stimulation level. Patients should be advised to turn down the amplitude or turn off the IPG before making posture
changes. If using therapy that does not produce a sensation, postural changes are less likely to affect the patient.
Wavewriter Alpha™ & WaveWriter Alpha™ Prime System Information for Prescribers
Device and Product Description
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