Boston Scientific Vercise DBS Information For Prescribers
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Boston Scientific Vercise DBS Information For Prescribers

Deep brain stimulation systems
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Vercise™ Deep Brain
Stimulation Systems
Information for
Prescribers
CAUTION: Federal law
restricts this device to sale,
distribution and use by or
on the order of a physician.
Content: MP92366224-01 REV A
92366224-01

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Summary of Contents for Boston Scientific Vercise DBS

  • Page 1 Vercise™ Deep Brain Stimulation Systems Information for Prescribers CAUTION: Federal law 92366224-01 restricts this device to sale, Content: MP92366224-01 REV A distribution and use by or on the order of a physician.
  • Page 2 , and Vercise Read all instructions carefully before using the DBS System. For other device‑specific information not included in this manual, refer to the appropriate DFU for your Boston Scientific DBS System as listed in your DBS Reference Guide. 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.

  • Page 3: Table Of Contents

    Table of Contents Device Description ..................1 Intended Use / Indications for Use ................1 Safety Information ................... 2 Contraindications..................... 2 Warnings ......................... 3 Precautions ......................6 Adverse Events ....................... 12 Service and Maintenance................14 External Trial Stimulator (ETS) Maintenance ............14 Cleaning the Charging System ................
  • Page 4 Vercise™ Deep Brain Stimulation Systems Information for Prescribers This page intentionally left blank. Vercise™ Deep Brain Stimulation Systems Information for Prescribers 92366224-01 iv of iv...

  • Page 5: Device Description

    The Boston Scientific Deep Brain Stimulation (DBS) System provides a reversible therapy where structures in the brain are stimulated with small electrical pulses. A Boston Scientific DBS System utilizes current steering (also known as multiple independent current control or MICC) across eight or sixteen Contacts per DBS Lead to provide precise positioning of stimulation.

  • Page 6: Safety Information

    Safety Information Contraindications The Boston Scientific DBS System, or any of its components, is contraindicated for the following: Diathermy: Shortwave, microwave, and/or therapeutic ultrasound diathermy should not be used on patients implanted with the Boston Scientific DBS System, or any of the system components.

  • Page 7: Warnings

    DBS Extension Connector: Implanting the DBS Lead Extension Connector in the soft tissue of the neck may increase the chance of DBS Lead breakage. Boston Scientific recommends placing the DBS Lead Extension Connector behind the ear such that glasses or headgear do not interfere with the implanted DBS System.
  • Page 8 ImageReady™ MRI Guidelines for Boston Scientific DBS Systems are followed. The ImageReady™ MRI Guidelines for Boston Scientific DBS Systems manual appears on the Boston Scientific website www.bostonscientific.com/manuals or may be provided in your region. It is important to read the information in this supplemental manual in its entirety before conducting or recommending an MRI examination on a patient with a Boston Scientific DBS System.
  • Page 9 Therapeutic Ultrasound: Implanted components of the Boston Scientific DBS System should not be exposed to therapeutic levels of ultrasound energy. The implanted device may concentrate the ultrasound field and may cause patient harm.

  • Page 10: Precautions

    Ensure that the devices are not in use while performing service and maintenance tasks. Component Removal, Disposal, and Return: Any explanted components should be returned to Boston Scientific. The Stimulator should be explanted in the case of cremation and returned to Boston Scientific. Cremation may cause the Stimulator battery to explode.
  • Page 11 Replace the dropped Stimulator with a new, sterile Stimulator prior to implantation. Return the damaged Stimulator to Boston Scientific. • Do not use any component that shows signs of damage.
  • Page 12 Vercise™ Deep Brain Stimulation Systems Information for Prescribers Medical Devices/Therapies: The following medical therapies or procedures may turn stimulation off, cause permanent damage to the Stimulator, or may cause injury to the patient. If any of the procedures below is required by medical necessity, the procedure(s) should be performed as far from the implanted components as possible.
  • Page 13 Sterilization: Contents of the surgical kits are supplied sterile using an ethylene oxide process. Do not use if sterile barrier is damaged. If damage is found, call Boston Scientific Technical Support and return the damaged part to Boston Scientific.
  • Page 14 Vercise™ Deep Brain Stimulation Systems Information for Prescribers Stimulator Orientation: Orient the Stimulator parallel to the skin surface. Suboptimal placement of the Stimulator may result in a revision surgery. Patients should avoid touching the Stimulator site or incisions. If patients notice a change in the appearance of the skin at the Stimulator location, such as the skin becoming thin over time, they should contact their healthcare provider.
  • Page 15 Temperatures outside of the stated range can cause damage. If stored in conditions beyond the required storage temperature, do not use the components and return to Boston Scientific. The non‑rechargeable Stimulator will enter storage mode if its temperature falls below 5 °C. When the Stimulator is in storage mode, it will not connect to a Remote Control or Clinician Programmer.

  • Page 16: Adverse Events

    Vercise™ Deep Brain Stimulation Systems Information for Prescribers Adverse Events The following is a list of known risks with the use of deep brain stimulation. There may be risks that are unknown. Note that some of these symptoms may be resolved or reduced by current steering, changing stimulation parameters, or by changing the position of the Lead during surgery.
  • Page 17 Safety Information • Pain, headache or discomfort • Pneumonia from difficulty with swallowing or from inhaling fluid • Psychiatric disturbances such as anxiety, depression, lessened interest or emotion, hypersexuality, aggression, mania or hypomania, psychosis, emotional sensitivity, sleep problems, suicide, or suicidal thoughts or attempts •...

  • Page 18: Service And Maintenance

    Vercise™ Deep Brain Stimulation Systems Information for Prescribers Service and Maintenance External Trial Stimulator (ETS) Maintenance The ETS may be used to conduct intraoperative stimulation testing during the Lead implantation procedure. Refer to the DFU listed in your DBS Reference Guide for detailed procedure and guidelines for intraoperative testing.

  • Page 19: Cleaning The Charging System

    Service and Maintenance Cleaning the Charging System The components of the Charging System (Charger, Base Station, and Power Supply) can be cleaned using alcohol or a mild detergent applied with a cloth or tissue. Residue from soapy detergents should be removed with a damp cloth. Do not use abrasive cleansers for cleaning. Do not clean any of the accessories while they are directly or indirectly connected to a power outlet.

  • Page 20: Electromagnetic Compatibility

    Table 1: Guidance and Manufacturer’s Declaration Electromagnetic Emissions The Boston Scientific DBS System is intended for use in electromagnetic environment specified below. The customer or the user of the Boston Scientific DBS System should ensure that it is used in such an environment. Electromagnetic Environment...
  • Page 21 Electromagnetic Immunity The Boston Scientific DBS System is intended for use in the electromagnetic environment specified below. The customer or the user of the Boston Scientific DBS System should assure that it is used in such an environment. IEC 60601‑1‑2...
  • Page 22 40 % U Voltage dips, short environment. If the user of interruptions and (60 % dip in U (60 % dip in U the Boston Scientific DBS voltage variations on for 5 cycles for 5 cycles System requires continued power supply input operation during power lines IEC 61000‑4‑11...
  • Page 23 Electromagnetic Immunity The Boston Scientific DBS System is intended for use in the electromagnetic environment specified below. The customer or the user of the Boston Scientific DBS System should assure that it is used in such an environment. IEC 60601‑1‑2...
  • Page 24 Vercise™ Deep Brain Stimulation Systems Information for Prescribers Table 4: Immunity Testing RFID Readers The external electrical components of the Boston Scientific DBS System have been tested for immunity to interference from RFID readers per the following specifications. RFID Spec Per AIM 7351731...
  • Page 25 The Boston Scientific DBS System is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The users of the Boston Scientific DBS System can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Boston Scientific DBS System as recommended below, according to the maximum output power of the communications equipment.

  • Page 26: Essential Performance

    Vercise™ Deep Brain Stimulation Systems Information for Prescribers Essential Performance External Trial Stimulator The stimulation pulse shall meet the requirements for charge balance and amplitude while stimulation is on. Other External Devices Failure of the external electrical components will not result in an unacceptable risk to the user. Telemetry Information Vercise PC and Vercise Gevia DBS Systems The following parameters describe the wireless communication link between the Stimulator and...

  • Page 27: Quality Of Wireless Service

    Table 6: Table 6: Quality of Wireless Service of the Configure Tab (Vercise PC and Vercise Gevia) Typical Range Boston Scientific Between the Remote Control Between the Wand and Stimulator Type and Stimulator Stimulator Non‑Rechargeable...

  • Page 28: Troubleshooting Wireless Coexistence Issues

    Troubleshooting Wireless Coexistence Issues Other wireless and RF technology based equipment operating in close proximity to a similar frequency band may degrade the range and responsiveness of the Boston Scientific DBS System. If you experience issues with the wireless communication behavior between the...

  • Page 29: Wireless Security

    Creating a validated and encrypted communication link during each connection with a previously paired device. The additional application level authentication and encryption ensures that communication with the Stimulator is only accomplished by authorized Boston Scientific devices. Vercise™ Deep Brain Stimulation Systems Information for Prescribers 92366224-01...
  • Page 30 The CP logs and notifies the user upon detection of malicious software. 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.

  • Page 31: Fcc Compliance

    (1) This device may not cause harmful interference, and (2) This device must accept any interference received including interference that may cause undesired operation. The Boston Scientific DBS System components should only be serviced by Boston Scientific. Do not attempt to open or repair any of the components.

  • Page 32: Rechargeable Stimulator Battery

    Recharge Estimate Boston Scientific recommends any recharge schedule that fits the patient’s schedule and lifestyle while maintaining sufficient charge to maintain stimulation. Patients should expect a daily recharging time of 5 to 30 minutes per day or a periodic recharging time of 30 minutes to 4 hours every 1 to 2 weeks, but their recharge routine may vary depending on their stimulation parameters.

  • Page 33: Non-Rechargeable Stimulator Battery

    Non‑Rechargeable Stimulator Battery Non‑Rechargeable Stimulator Battery Stimulator Battery The longevity of the non‑rechargeable Stimulator battery depends on the following factors: • Programmed parameters • System impedance • Hours per day of stimulation • Changes to stimulation made by the patient For additional information on estimating the longevity of the non-rechargeable battery, refer to the appropriate Programming Manual as listed in your DBS Reference Guide.
  • Page 34 Legal Australian Sponsor EU Authorized Manufacturer Address Representative Boston Scientific Neuromodulation Boston Scientific (Australia) Pty Ltd Boston Scientific Limited Corporation PO Box 332 Ballybrit Business Park 25155 Rye Canyon Loop BOTANY Galway, Ireland Valencia, CA 91355 USA NSW 1455 T: +33 (0) 1 39 30 97 00...

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