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Important Safety Information

Parkinson's

 

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

Medtronic DBS Therapy for movement disorders

Indications: Medtronic DBS Therapy for Movement Disorders is indicated for patients with disabling tremor or symptoms of Parkinson's disease. Studies have shown that deep brain
stimulation with Medtronic DBS Therapy components is effective in controlling essential
tremor and symptoms of Parkinson's disease that are not adequately controlled with
medications. Additionally, deep brain stimulation is effective in controlling dyskinesias
and fluctuations associated with medical therapy for Parkinson's disease.

Medtronic DBS Therapy for Movement Disorders is also indicated as an aid in the management of chronic, intractable (drug refractory) primary dystonia, including
generalised and segmental dystonia, hemidystonia, and cervical dystonia (torticollis) for
individuals 7 years of age and older.


Clinicians, refer to the appropriate information for prescribers booklet for
contraindications, warnings, precautions, adverse events summary, patient selection,
and component disposal.

Patients, refer to your Medtronic DBS patient therapy guide for contraindications,
warnings, precautions, and other risk information.

Contraindications

Implantation of a DBS system is contraindicated for:

Diathermy - Patients exposed to diathermy. Do not use shortwave diathermy, microwave diathermy or therapeutic ultrasound diathermy (all now referred to as diathermy) on patients implanted with a neurostimulation system. Energy from diathermy can be transferred through the implanted system and can cause tissue damage at the location of the implanted electrodes, resulting in severe injury or death.

Diathermy can also damage the neurostimulation system components, resulting in loss of
therapy and requiring additional surgery for system explantation and replacement. Advise
your patient to inform all their health care professionals that they should not be exposed
to diathermy treatment.

Injury to the patient or damage to the device can occur during diathermy treatment when:
▪ the neurostimulation system is turned on or off.
▪ diathermy is used anywhere on the body — not just at the location of the
neurostimulation system.
▪ diathermy delivers heat or no heat.
▪ any component of the neurostimulation system (lead, extension, neurostimulator)
remains in the body.

Certain magnetic resonance imaging (MRI) procedures - Use of a full body transmit
radio-frequency (RF) coil, a receive-only head coil, or a head transmit coil that extends
over the chest area is contraindicated for patients with the following implanted DBS
systems or system components:
▪ Soletra Model 7426 Neurostimulator
▪ Kinetra Model 7428 Neurostimulator
▪ Activa SC Model 37602 Neurostimulator
▪ Model 64001 and Model 64002 pocket adaptors implanted with any DBS system

Tissue lesions from component heating, especially at the lead electrodes, resulting in
serious and permanent injury including coma, paralysis, or death, can occur if a
contraindicated MRI scan is performed on a patient with any of these DBS systems.
Refer to the MRI guidelines for Medtronic neurostimulation systems for deep brain
stimulation instructions for use manual associated with this product for
comprehensive safety information and instructions.


Unable to operate patient devices - Patients who are unable, or do not have the
necessary assistance, to properly operate the DBS Therapy patient programmer, magnet, or a charging system (applicable to rechargeable DBS Systems only).
Transcranial magnetic stimulation (TMS) - Contraindicated for use in patients with an
implanted DBS System.