Overview of the Boston Scientific Spinal Cord Stimulator Systems User Manual
The Boston Scientific Spinal Cord Stimulator Systems are cutting-edge medical devices designed to assist in managing chronic intractable pain of the trunk and extremities. Indications for use include a range of painful conditions such as failed back surgery syndrome, Complex Regional Pain Syndrome (CRPS) Types I and II, intractable low back, and leg pain. These are especially suited for patients suffering from associated conditions, which may include:
- Radicular pain syndrome and radiculopathies resulting from failed back surgery or herniated disc.
- Epidural fibrosis.
- Degenerative disc disease that is resistant to both conservative and surgical treatments.
- Arachnoiditis.
- Multiplicity of back surgeries.
The manual denotes CRPS I was historically known as Reflex Sympathetic Dystrophy (RSD) and CRPS II as causalgia. For complete information on contraindications, warnings, precautions, potential adverse events, detailed physician instructions, system sterilization, component disposal, and further contact details, it refers users to the ‘Information for Prescribers’ manual that comes with their specific Spinal Cord Stimulator (SCS) system.
Additional specificity-related data not included in the ‘Information for Prescribers’ should be sought from the Device Functionality Update (DFU) applicable to the user’s SCS system. Similarly, the Reference Guide can be consulted for listed labeling symbols and warranty details.
The legal manufacturer details are provided by Boston Scientific Neuromodulation, with headquarters in Valencia, California, USA, and the Australian sponsor is Boston Scientific (Australia) Pty Ltd. Boston Scientific makes its presence known internationally, featuring an EU Authorized Representative, the Boston Scientific Limited in Galway, Ireland. Customer service contact numbers and addresses are also stated for the United States, Canada, and Australia, along with other relevant international contact details and resources.
This user manual reflects revision 91005946-02 Rev A, issued in August 2017, affirming Boston Scientific Corporation’s proprietary rights over the content. The text establishes a foundational reference point for professionals engaged in the delivery of neuromodulation treatments using Boston Scientific products, ensuring they are provided with detailed instructions and support in the medical management of chronic pain conditions.
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