Vercise™ Deep Brain Stimulator Systems

Contraindications

The Boston Scientific Vercise™ DBS System, or any of its components, is contraindicated for: 

Diathermy. Shortwave, microwave and/or therapeutic ultrasound diathermy should not be used on patients implanted with the Vercise™ DBS System, or any of the system components. The energy generated by diathermy can be transferred to the Vercise™ DBS System, causing tissue damage at the contact site resulting in severe injury or death.

Electroconvulsive Therapy (ECT) and Transcranial Magnetic Stimulation (TMS). The safety of these therapies in patients implanted with the Vercise DBS System has not been established. It is possible that the energy generated by these therapies can be transferred to the Vercise DBS System, causing tissue damage that may result in severe patient injury or death.

Magnetic Resonance Imaging (MRI). Patients implanted with the full Vercise DBS System (Leads, Extensions, and Stimulator) should not be subjected to MRI. MRI exposure may result in:

• Dislodgement of implanted components.
• Heating of the contacts, or other system components, causing permanent tissue lesioning.
• Damage to the Stimulator’s electronics.
• Current induction through the DBS Leads and Vercise DBS System causing unpredictable levels of stimulation.
• Distortion of the diagnostic image.
• Personal injury or death.

Note: Vercise DBS Lead‑Only System (before Stimulator is implanted) is MR Conditional. An MRI examination can be conducted safely when all the instructions in the supplemental manual MRI Guidelines for Boston Scientific DBS Systems are followed. 

For the latest version of the manual go to www.bostonscientific.com/manuals.

Patient Incapability. Patients who are unable to properly operate the Remote Control and Charging System should not be implanted with the Vercise DBS System.

Poor Surgical Candidates. The Vercise DBS System is not recommended for patients who are poor surgical candidates.

Unsuccessful Test Stimulation. The Vercise DBS System should not be used in patients who experience unsuccessful test stimulation.

Unauthorized Modification. 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.

Intracranial Hemorrhage. Special precautions should be taken for patients who are prone to hemorrhage including patients with coagulopathy, with high blood pressure, or who are using prescribed anticoagulants. Microelectrode penetration and DBS Lead insertion can put patients who have a likelihood of intracranial hemorrhages at greater risk.

Charge Density. High levels of stimulation may damage brain tissue. Whenever possible, the current amplitude and pulse width should be programmed such that the charge density is below 30 µC/cm2 per stimulation phase. To maintain safety limits, the software will display a warning when the level of stimulation exceeds 30 µC/cm2 per stimulation phase; however, the software allows the stimulation to be adjusted above this level by the physician.

Patients may have the ability to change the amplitude with the Remote Control. Set and verify the maximum and minimum amplitude levels allowed by the Remote Control to ensure that current levels remain safe.

Electromagnetic Interference. Strong electromagnetic fields can potentially turn the Stimulator off, cause temporary unpredictable changes in stimulation, or interfere with the Remote Control communication. Patients should be counseled to avoid or exercise care around:

• Theft detectors, tag deactivators and RFID devices, such as those used at department stores, libraries, and other public establishments. The patient should proceed with caution, ensuring to move through the center of the detector as quickly as possible.
• Security screeners, such as those used in Airport Security or at entrances to government buildings, including hand-held scanners. The patient should request assistance to bypass the device. If the patient must pass through the security screener, they should move quickly through the device staying as far from the physical device as allowable.
• Power lines or power generators.
• Electric steel furnaces and arc welders.
• Large magnetized stereo speakers.
• Strong magnets.
• Automobiles or other motorized vehicles using a LoJack system or other anti-theft systems that can broadcast a radio frequency (RF) signal. The high energy fields produced by these systems may interfere with the operation of the Remote Control and its ability to control stimulation.
• Other sources of electromagnetic disturbance, such as RF transmitters at television or radio broadcast stations, Amateur Radio or Citizens Band radio transceivers, or Family Radio Service band transceivers.
  

Note: When in close proximity, equipment that generates strong electromagnetic fields might cause unintended stimulation or interfere with wireless communication even if they comply with International Special Committee on Radio Interference (CISPR) requirements.

DBS Extension Connector and Stimulator Placement. Implanting the DBS Extension connector in the soft tissue of the neck may increase the chance of DBS Lead breakage. Boston Scientific recommends placing the DBS Extension connector behind the ear such that glasses or headgear do not interfere with the system. Boston Scientific recommends that the Stimulator be placed subclavicularly.

Heat Due to Charging 
The Charger may become warm while charging the Stimulator. The Charger should be handled with care. Failure to use either the Charging Collar or an Adhesive Patch while charging, as directed, may result in a burn. The Patient should not charge while sleeping. This may result in a burn. If the patient experiences pain or discomfort, they should cease charging and contact their physician.

Stimulator Damage. Chemical burns may result if the Stimulator housing is ruptured or pierced, exposing the patient’s tissue to battery chemicals. Do not implant the Stimulator if the housing is damaged.

Suicide. New onset or worsening depression which may be temporary or permanent is a risk that has been reported with DBS therapy. Suicidal ideation, suicide attempts, and suicide are events that have also been reported. Therefore, physicians should consider the following:

• Preoperatively, assess patients for the risks of depression and suicide. This assessment should consider both the risk of depression and suicide as well as the potential clinical benefits of DBS therapy for the condition being treated.
• Postoperatively, actively monitor patients for new or worsening symptoms of depression, suicidal thoughts or behaviors, or changes in mood or impulse control.
• If a patient experiences new or worsening depression or suicidal ideation, manage these symptoms appropriately.
• Educate patients and caregivers about these potential risks prior to implantation, and be sure that they know about the importance of ongoing support and follow-up, including when to contact their health care provider.

Other Active Implantable Devices. Stimulators, such as the Vercise™ Stimulator, may interfere with the operation of implanted devices such as pacemakers, cardioverter defibrillators, or medication delivery pumps. The effects of implanted stimulation devices on neurostimulators, such as the Vercise DBS System, are unknown.

Automobiles and Equipment. Patients should operate automobiles, other motorized vehicles, or potentially dangerous machinery/equipment with caution after receiving the Vercise DBS System. Performing activities that would be dangerous if treated symptoms were to return, or instances in which stimulation changes occur, should be avoided.

Pregnancy. It is unknown whether this device may hurt an unborn baby.

Physician training is required for usage of the Vercise™ DBS System. The implanting physician should be experienced in the subspecialty of Stereotactic and Functional Neurosurgery. The following is a list of precautions that should be taken when implanting or using the DBS Stimulator.

Connections. Before inserting any DBS Lead or DBS Extension into any connector or header ports, including the Stimulator header, DBS Extension connectors, and operating room cable assembly, always wipe the DBS Lead with a dry cotton sponge. Contamination inside the ports may be difficult to remove and can cause high impedances, preventing electrical connectivity which may compromise the integrity of the stimulation circuit.

Components. The use of components other than those supplied by Boston Scientific and intended for use with the Vercise DBS System may: damage the system, diminish the effectiveness of therapy, and/or put the patient at unknown risk.

Excess DBS Extension. Coil excess DBS Extension around or below the Stimulator. Excess wire on top of the Stimulator may increase the potential for tissue erosion or damage during Stimulator replacement surgery and may interfere with charging.

Other Models of External Devices. Only the Remote Control, Clinician Programmer, and Charger that were provided with the Boston Scientific Vercise™ DBS System should be used with the Vercise DBS System. Other models of these devices will not function with the Vercise DBS System.

Stimulator Orientation. To ensure proper charging, orient the Stimulator parallel to the skin surface and at a depth less than 2 cm below the skin. The etched writing “This Side Up” must be facing out of the pocket towards the patients skin. Suboptimal placement of the Stimulator may result in the inability to recharge and/or a revision surgery.

Never attempt to change the orientation of or turn over the Stimulator. Patients should avoid touching the Stimulator site or incisions. If the Stimulator flips over in the body, then it cannot be charged. If stimulation cannot be turned on after charging, the Stimulator may have changed orientation or rotated; patients should contact their physician to arrange an evaluation of the system.

If a patient notices a change in appearance of the skin at the Stimulator location, such as the skin becoming thin over time, they should contact their physician.

Setscrews. Before tightening Setscrews, always test impedance to confirm electrical connectivity. Tightening a Setscrew onto a contact may damage the contact and may result in the need to replace the DBS Lead or DBS Extension.

Sutures. Do not apply sutures tightly around the DBS Leads, as this may damage the DBS Leads’ insulation and may result in DBS Lead failure.

Surgical Tape. If tape is used to temporarily secure the DBS Lead during surgery, caution should be used to ensure the Lead is not cut or damaged when removing the tape.

Device Failure. Implants can fail at any time due to random component failure, loss of battery functionality, or DBS Lead breakage. Suddenly stopping brain stimulation can cause serious reactions to develop. If the Stimulator stops working even after complete charging (up to four hours when properly aligned), patients should be instructed to turn off the Stimulator and contact their physician immediately so that the system can be evaluated and appropriate medical care given to manage the return of symptoms.

Tissue Reaction. Temporarily, there may be some pain in the area of the Stimulator as the incisions heal. If there is excessive redness around the wound area, it should be checked for infection. In rare cases, adverse tissue reaction to implanted materials can occur.

Cell Phones. While interference caused by cell phones is not anticipated, the full effects of interaction with cell phones are unknown at this time.

Patient Activities Requiring Coordination. Loss of coordination is a potential side effect of DBS therapy. Patients should exercise reasonable caution when participating in activities requiring coordination, including those that they were able to perform prior to receiving DBS therapy (e.g., swimming).

Bathing. Patients should exercise reasonable caution when bathing.

Patient Activity Following Surgery. During the two weeks following surgery, it is important for the patient to exercise extreme care so that appropriate healing will secure the implanted components. During this period, the patient should not attempt to move heavy objects. Instruct the patient to restrict head movements, including extension or flexion of the neck and rotation of the head, until healing is complete.

Massage Therapy. Patients should avoid receiving massage therapy near the implanted system components. If a patient does receive massage therapy, the patient should inform the masseuse that they have an implanted device and show him/her where the Stimulator, DBS Extension, and DBS Leads are located. The patient should have the masseuse avoid these areas and proceed with caution.

Environmental Precautions. Patients should avoid activities that could potentially involve large amounts of electromagnetic interference. Devices that contain permanent magnets, such as speakers, should not be placed near the Stimulator because they may cause the system to turn on or off.

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.

Stimulator function should be confirmed after the procedure. Ultimately, however, the Stimulator may require explanation as a result of damage to the device or patient harm.

• Electrocautery – Electrocautery can transfer destructive current into the DBS Leads and/or Stimulator.
• External Defibrillation – Safe usage of external defibrillation has not been established. 
• Lithotripsy – High frequency signals directed near the Stimulator may damage circuitry.
• MRI – Patients implanted with the full Vercise DBS System (Leads, Extensions, and Stimulator) should not be subjected to MRI to avoid damage to the device and patient harm.

Note: Vercise DBS Lead‑Only System (before Stimulator is implanted) is MR Conditional. An MRI examination can be conducted safely when all the instructions in the supplemental manual MRI Guidelines for Boston Scientific DBS Systems are followed.

For the latest version of the manual go to www.bostonscientific.com/manuals.

• Radiation Therapy – Lead shielding should be used over the Stimulator to prevent damage from high radiation. Any damage to the device by radiation may not be immediately detectable.
• X-ray and CT scans may damage the Stimulator if stimulation is on. X-Ray and CT Scans are unlikely to damage the Stimulator if stimulation is turned off.

Diagnostic ultrasonic scanning is unlikely to damage the Stimulator if stimulation is turned off.

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 your Boston Scientific representative and return the damaged part to Boston Scientific.

Single Use Only. Do Not Resterilize. For single patient use only. Do not reuse, reprocess or resterilize. Reuse, reprocessing or resterilization may compromise the structural integrity of the device and/or lead to device failure which, in turn, may result in patient injury, illness or death. Reuse, reprocessing or resterilization may also create a risk of contamination of the device and/or cause patient infection or cross-infection, including, but not limited to, the transmission of infectious disease(s) from one patient to another. Contamination of the device may lead to injury, illness or death of the patient.

Inspect Packaging Before Use. Check the expiration date on the package before opening the sterile package and using the contents. Do not use the contents if the current date is past the expiration date, if the package is opened or damaged, or if contamination is suspected because of a defective sterile package seal.

• Inspect the seal integrity of the outer tray before use.
• Inspect the seal integrity and sterile indicator on the inner tray. The sterile indicator will be green with red stripes if sterile. Yellow stripes indicate the tray is not sterile. If the tray is not sterile, do not use the components and return to Boston Scientific.
• Open the inner tray in the sterile field.
• If the Stimulator was dropped, do not implant it in a patient. The dropped Stimulator may have lost sterility, experienced a loss of hermeticity, or been otherwise damaged. 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.
• Do not use if “Use By” date has expired.

Operating Temperature. The operating temperature of the ETS and Remote Control is 5 °C to 40 °C (41 °F to 104 °F). For proper operation, do not use the Charging System if the ambient temperature is above 35 °C (95 °F).

Storage, Handling and Transport. Store implanted components like Stimulators, Leads, and Extensions between 0 °C to 45 °C (32 °F to 113 °F) in an area where they are not exposed to liquids or excessive moisture. 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. Store external components like the Remote Control, ETS, OR Cable and Extension, and Charging System between -20 °C to 60 °C (-4 °F to 140 °F). Do not expose them to excessively hot or cold conditions. Do not leave the devices in your car or outdoors for extended periods of time. The sensitive electronics can be damaged by temperature extremes, particularly high heat. Handle the system components and accessories with care. Do not drop them or submerge them in water. Accessories, including the Remote Control, Charger, and charging components must be kept dry and not be exposed to moisture. 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 the components. Keep the Remote Control, Charger, and charging components away from pests, pets, and children to avoid damage to the devices. Care must be taken to avoid damaging the DBS Lead with sharp instruments or excessive force during surgery. The following guidelines will help to ensure the longevity of components:

• Do not sharply bend or kink the DBS Lead or Extension.
• Do not tie suture(s) directly to the DBS Lead or Extension body.
• Avoid pulling an implanted DBS Lead taut; stress relief loops may help to minimize tension on the DBS Lead.
• Avoid handling the DBS Lead with sharp instruments; use only rubber-tipped forceps.
• Take care when using sharp instruments, such as hemostats or scalpels to prevent damaging the DBS Lead.

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.

The Remote Control or Charging System should not be disposed of in fire, as these components contain batteries which may explode causing injury when exposed to fire. Used batteries should be disposed of in accordance with local laws and regulations.

Dispose of non-implantable components and packaging in accordance with hospital, administrative and/or local government policy.

Cleaning the Charging Collar. Hand wash the Charging Collar with mild soap and warm water. Do not machine wash the charging collar. Let the Charging Collar air dry. Be sure to remove the Charger and Counterweight from the Charging Collar before washing the Charging Collar.

Cleaning the Remote Control, External Trial Stimulator (ETS), Charger, Base Station, & Power Supply. The components 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 the Charger, Base Station, or Power Supply while they are directly or indirectly connected to a power outlet.

The following is a list of known risks with the use of Deep Brain Stimulation for treatment of Parkinson’s disease. 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. If any of these events occur, patients should contact their physician as soon as possible to inform them.

Risks Associated With Surgical Procedure and Post‑Operative Period:

• Allergic reaction to anesthesia or antibiotics including anaphylaxis
• Blood clot formation in the extremities (e.g., in the veins of the legs)
• Blood clot or air forming in or traveling through the blood stream, which can block blood flow to parts of the lungs or other tissue that could be life-threatening
• Brain contusion (bruising)
• Brain or cerebral spinal fluid (CSF) infection or inflammation
• CSF leaking outside the skull or collecting inside the skull abnormally
• Confusion or problems with attention, thinking, or memory (acute or chronic)
• Death
• Fibrosis (thickened skin and scarring) around the Lead Extension (including tightening, tethering, and bowstringing)
• Hemiparesis (muscular weakness or partial paralysis on one side of the body)
• Hemiballism (uncontrollable involuntary movements of a limb or limbs on one or both sides of the body)
• Intracranial hemorrhage (which can lead to stroke, paralysis, or death)
• Intraparenchymal cyst
• Infection
• Injury to areas next to the implant, such as blood vessels, nerves, the chest wall, and the brain
• Injury to the nerves in the armpit (brachial plexus) leading to pain or weakness of the arm or hand
• Neurosurgery/anesthesia risks, including unsuccessful implant and pneumonia
• Pain at the surgical site(s), headache or discomfort
• Seizures
• Speech or language difficulties
• Subcutaneous hemorrhage or seroma (blood or fluid collection under the skin, including the skin over the skull)
• Stroke resulting in temporary or permanent problems
• Swelling or bruising of the muscles or skin in the area of the Lead or of the IPG implant

Possible Side‑Effects of Stimulation

• Confusion or problems with attention, thinking, or memory
• Gait difficulty (trouble walking) and falls
• New onset or worsening depression, which may be temporary or permanent, and suicidal ideations, suicide attempts, and suicide
• 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
• Seizures
• Sensory changes
• Speech or language problems
• Swallowing difficulty
• Systemic effects such as rapid heart beat, sweating, fever, dizziness, changes in kidney function, difficulty passing urine, sexual effects, nausea, difficulty having bowel movements, bloating
• Weakness, muscle spasms, shaking, restlessness, or problems with movement•      Undesirable sensations (e.g., tingling)
• Visual problems, eyelid or eye movement difficulties or other eye-related symptoms
• Weight changes

Device‑Related Risks

• Allergic or immune system response to implanted materials
• Failure or malfunction of any part of the device, including but not limited to: Battery leakage, battery failure, Lead or Extension breakage, hardware malfunctions, loose connections, electrical shorts or open circuits, and Lead insulation breaches, whether or not these problems require device removal and/or replacement
• Implant site complications such as pain, poor healing, redness, warmth, swelling or wound reopening
• Implanted device components (Stimulator, Lead, or Extension) may move from original implanted location or wear through the skin, which may lead to the need for additional surgery
• Infection
• Interference from external electromagnetic sources
• Loss of adequate stimulation
• Pain, headache or discomfort
• Skin irritation or burns at the Stimulator site
• Stiffness in muscles or joints
• Worsening of disease symptoms, potentially caused by loss of stimulation, medication changes, surgery, or illness. In rare cases worsening can become a life-threatening crisis associated with varied symptoms such as mental status changes, fever, and muscle rigidity
• Swelling, including fluid collecting around the device