Activa Parkinson's Control Therapy, Tremor Control Therapy, and Dystonia Therapy: Product technical manual must be reviewed prior to use for detailed disclosure.
Reclaim™ DBS Therapy for Obsessive-Compulsive Disorder: Product technical manual must be reviewed prior to use for detailed disclosure.
Product manuals must be reviewed prior to use for detailed disclosure.
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.
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.
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 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 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 tissue damage and can result in severe injury or death. Diathermy can damage parts of the neurostimulation system.
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.
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.
USA Rx only Rev 0209
Product manuals must be reviewed prior to use for detailed disclosure.
The Medtronic Reclaim DBS Therapy is indicated for bilateral stimulation of the anterior limb of the internal capsule, AIC, as an adjunct to medications and as an alternative to anterior capsulotomy for treatment of chronic, severe, treatment-resistant obsessive compulsive disorder (OCD) in adult patients who have failed at least three selective serotonin reuptake inhibitors (SSRIs).
Contraindications include patients who are unable to properly operate the neurostimulator, and patients who will be exposed to MRI or diathermy. MRI and diathermy (e.g., shortwave diathermy, microwave diathermy or therapeutic ultrasound diathermy) are contraindicated because the 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. Transcranial Magnetic Stimulation (TMS) is contraindicated for patients with an implanted DBS System.
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. Severe burns could result if
the neurostimulator case is ruptured or pierced. The safety of somatic psychiatric therapies using
equipment that generates electromagnetic interference (e.g., vagus nerve stimulation) has not been
established. The Reclaim 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. Patients should be monitored for at least 30 minutes
after a programming session, for side effects, including: autonomic effects (e.g., facial flushing, facial
muscle contractions, or increased heart rate), hypomania, increased disease symptoms, sensations such
as tingling, smell, or taste. In addition, during treatment, patients should be monitored closely for
increased depression, anxiety, suicidality, and worsening of obsessive-compulsive symptoms. The safety
and probable benefit of this therapy has not been established for patients with: Tourette’s syndrome,
OCD with a subclassification of hoarding, previous surgical ablation (e.g., capsulotomy), dementia,
coagulopathies or who are on anticoagulant therapy, neurological disorders, and other serious medical
illness including cardiovascular disease, renal or hepatic failure, and diabetes mellitus. In addition, the
safety and probable benefit has not been established for these patients: those whose diagnosis of OCD is
documented to be less than 5 years duration or whose YBOCS score is less then 30, who have not
completed a minimum of 3 adequate trials of first and/or second line medications with augmentation,
who have not attempted to complete an adequate trial of cognitive behavior therapy (CBT), who are
pregnant, under the age of 18 years, and who do not have comorbid depression and anxiety. Physicians
should carefully consider the potential risks of implanting the Reclaim DBS System in patients with
comorbid psychiatric disorders (e.g., bipolar, body dysmorphic, psychotic) as the Reclaim DBS System
may aggravate the symptoms. Additionally, the abrupt cessation of stimulation for any reason should be
avoided as it may cause a return or worsening (i.e., “rebound” effect) of disease symptoms. Serious
adverse events related to the therapy, device, or procedure can include: suicidality/ increased depression,
increased OCD/fluctuating results, intracranial hemorrhage, lead/extension failure, aggression/ violent
behavior, accident proneness, irritability, death, hypomania, infection, pyelonephritis, and post-operative
seizure. Adverse events related to the therapy, device, or procedure can include: coma, paralysis, pain or
discomfort at incision/implant sites, general post-op discomfort, GI symptom (post op), increased
anxiety, insomnia, cognitive disturbance (clouding), induced muscle contraction, restlessness,
stimulation induced paresthesia, device migration, shocking or jolting stimulation, induced sensation of
taste/smell, weight gain, increased fatigue, upper respiratory infection, headaches, dizziness, dry mouth,
itching at surgical site(s), nausea, sedation, and weight loss.
Authorized by Federal (U.S.A) law for use as an adjunct to medications and as alternative to anterior capsulotomy for treatment of chronic, severe, treatment-resistant obsessive compulsive disorder (OCD) in adult patients who have failed at least three selective serotonin reuptake inhibitors (SSRIs). The effectiveness of this device for this use has not been demonstrated.
USA Rx only Rev 0209