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Important Safety Information
Brief Summary Disclosure for Parkinson's Control, Tremor Control and Dystonia Therapies:
Activa® Parkinson's Control Therapy: Patients
should always discuss the potential risks and benefits
with a physician.
Indications:
Parkinson's Control Therapy: Bilateral stimulation
of the internal globus pallidus (GPi) or the subthalamic nucleus
(STN) using Medtronic® Activa® Parkinson’s
Control Therapy 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.
Tremor Control Therapy: Unilateral thalamic
stimulation by the Medtronic® Activa® Tremor
Control System 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 or Parkinsonian 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.
Dystonia Therapy: Unilateral or bilateral stimulation of the internal
globus pallidus (GPi) or the subthalamic nucleus (STN) by the Medtronic
Activa System 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, a receive-only head coil, or a head
transmit coil that extends over the chest area, patients who
are unable to properly operate the neurostimulator, or for Parkinsons’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
tissue damage and can result in severe injury or death. Diathermy
can damage parts of the neurostimulation 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. Do
not place the lead-extension connector in the soft tissues of the
neck. Placement in this location has been associated with 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
Activa System, clinicians should carefully weigh the decision to
use MRI in patients with an implanted Activa System. MRI can cause
induced voltages in the neurostimulator and/or lead possibly causing
uncomfortable, jolting, or shocking levels of stimulation. MRI image
quality may be reduced for patients who require the neurostimulator
to control tremor, because the tremor may return when the neurostimulator
is turned off.
Severe burns could result if the neurostimulator case is ruptured
or pierced. The Activa 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. Additionally,
the abrupt cessation of stimulation for any reason should be avoided
as it may cause a return of disease symptoms. In some cases, symptoms
may return 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.
Humanitarian Device (Dystonia Therapy):
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.
Rx only
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