Description

The Alterna High Output System is an advanced implantable neurostimulation solution designed to manage chronic pain and neurological conditions such as Parkinson's disease, essential tremor, and dystonia. This sophisticated system comprises several key components, including implantable pulse generators (IPGs), leads, extensions, and external devices such as clinician programmers and patient controllers.

Key Features

• Implantation Guidelines: The system requires specific surgical considerations, such as the exclusive use of bipolar electrosurgery during implant procedures. Electrosurgery should be completed before connecting leads or extensions to the neurostimulator to ensure optimal performance and safety.

• Device Handling: Care must be taken to keep the programmer and controller dry, as they are not waterproof. Additionally, only approved components should be used with the system to prevent potential damage.

• Sterility and Single Use: The system's components are intended for single use and are sterilized with ethylene oxide. They should not be resterilized or reused, and proper handling is essential to maintain sterility.

Safety Precautions

• Device Interactions: Patients with other implanted devices, such as pacemakers or defibrillators, should be aware of potential interactions. The system's safety for pediatric use, pregnancy, and nursing has not been established, and some materials may cause allergic reactions.

• Environmental Considerations: High-output devices and certain electronic equipment may affect the system's functionality. Patients are advised to exercise caution in environments with security devices, RFID devices, and wireless restrictions.

Potential Adverse Effects

Users may experience sensations or motor disturbances at high outputs, changes in stimulation, or lead migration. Other risks include infection, spinal cord compression, and cerebrospinal fluid leakage. Proper surgical technique and post-operative care are crucial to minimizing these risks.

Compatibility

The Alterna High Output System is noted for its compatibility with specific filtration products, enhancing its versatility in various medical settings. This feature underscores the importance of adhering to recommended guidelines to ensure seamless integration and optimal outcomes.

The Alterna High Output System represents a significant advancement in neurostimulation technology, offering tailored solutions for individuals with complex neurological needs. Its comprehensive design and robust safety measures provide healthcare professionals with a reliable tool to improve patient quality of life. The system's effectiveness hinges on meticulous adherence to handling and implantation guidelines, ensuring long-term success and patient satisfaction.