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Important Safety Information

Medtronic DBS Therapy for Parkinson’s Disease, Tremor, and Dystonia: Patients should always discuss the potential risks and benefits with a physician.

Indications:

Medtronic DBS Therapy for Parkinson's Disease:

Bilateral stimulation of the internal globus pallidus (GPi) or the subthalamic nucleus (STN) using Medtronic DBS Therapy for Parkinson’s Disease is indicated for adjunctive therapy in reducing some of the symptoms of advanced, levodopa-responsive Parkinson’s disease that are not adequately controlled with medication.

Medtronic DBS Therapy for Tremor:

Unilateral thalamic stimulation using Medtronic DBS Therapy for Tremor is indicated for the suppression of tremor in the upper extremity. The system is intended for use in patients who are diagnosed with Essential Tremor not adequately controlled by medications and where the tremor constitutes a significant functional disability. The safety or effectiveness of this therapy has not been established for bilateral stimulation.

Medtronic DBS Therapy for Dystonia:

Unilateral or bilateral stimulation of the internal globus pallidus (GPi) or the subthalamic nucleus (STN) using Medtronic DBS Therapy for Dystonia is indicated as an aid in the management of chronic, intractable (drug refractory) primary dystonia, including generalized and segmental dystonia, hemidystonia, and cervical dystonia (torticollis), for individuals 7 years of age and older.

Contraindications:

Contraindications include patients who will be exposed to MRI using a full body radio-frequency (RF) coil or a head transmit coil that extends over the chest area, patients who are unable to properly operate the neurostimulator, or for Parkinson’s disease and Essential Tremor, patients for whom test stimulation is unsuccessful. Also, diathermy (e.g., shortwave diathermy, microwave diathermy or therapeutic ultrasound diathermy) is contraindicated because diathermy's energy can be transferred through the implanted system (or any of the separate implanted components), which can cause neurostimulation system or tissue damage and can result in severe injury or death. Transcranial Magnetic Stimulation (TMS) is contraindicated for patients with an implanted DBS System.

Warnings/ Precautions/Adverse Events:

There is a potential risk of tissue damage using stimulation parameter settings of high amplitudes and wide pulse widths. Extreme care should be used with lead implantation in patients with a heightened risk of intracranial hemorrhage. The lead-extension connector should not be placed in the soft tissues of the neck due to an increased incidence of lead fracture. Theft detectors and security screening devices may cause stimulation to switch ON or OFF, and may cause some patients to experience a momentary increase in perceived stimulation. Although some MRI procedures can be performed safely with an implanted DBS System, clinicians should carefully weigh the decision to use MRI in patients with an implanted DBS System. MRI can cause induced voltages in the neurostimulator and/or lead possibly causing uncomfortable, jolting, or shocking levels of stimulation.

The DBS System may be affected by or adversely affect medical equipment such as cardiac pacemakers or therapies, cardioverter/ defibrillators, external defibrillators, ultrasonic equipment, electrocautery, or radiation therapy. Safety and effectiveness has not been established for patients with neurological disease other than Parkinson’s disease or Essential Tremor, previous surgical ablation procedures, dementia, coagulopathies, or moderate to severe depression; or for patients who are pregnant, under 18 years, over 75 years of age (Parkinson’s Control Therapy) or over 80 years of age (Tremor Control Therapy). For patients with Dystonia, age of implant is suggested to be that at which brain growth is approximately 90% complete or above. Depression, suicidal ideations and suicide have been reported in patients receiving Medtronic DBS Therapy for Movement Disorders, although no direct cause and effect relationship has been established.

Abrupt cessation of stimulation should be avoided as it may cause a return of disease symptoms, in some cases with an intensity greater than was experienced prior to system implant (“rebound” effect). Adverse events related to the therapy, device, or procedure can include: stimulation not effective, cognitive disorders, pain, dyskinesia, dystonia, speech disorders including dysarthria, infection, paresthesia, intracranial hemorrhage, electromagnetic interference, cardiovascular events, visual disturbances, sensory disturbances, device migration, paresis/asthenia, abnormal gait, incoordination, headaches, lead repositioning, thinking abnormal, device explant, hemiplegia, lead fracture, seizures, respiratory events, and shocking or jolting stimulation. Patients using a rechargeable neurostimulator for Parkinson’s Control Therapy or Tremor Control Therapy should check for skin irritation or redness near the neurostimulator during or after recharging, and contact their physician if symptoms persist.

Humanitarian Device (Dystonia):

Authorized by Federal Law for the use as an aid in the management of chronic, intractable (drug refractory) primary dystonia, including generalized and segmental dystonia, hemidystonia, and cervical dystonia (torticollis), for individuals 7 years of age and older. The effectiveness of this device for this use has not been demonstrated.

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