Indications, Safety and Warnings
Reclaim® Deep Brain Stimulation Therapy for Obsessive-Compulsive Disorder: Product labeling must be reviewed prior to use for detailed disclosure of risks.
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 will be exposed to MRI using a full body transmit radio-frequency (RF) coil, a receive-only head coil, or a head transmit coil that extends over the chest area if they have an implanted Soletra Model 7426 Neurostimulator, Kinetra Model 7428 Neurostimulator, Activa SC Model 37602 Neurostimulator, or Model 64001 or 64002 pocket adaptor, and patients who are unable to properly operate the neurostimulator. 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. Transcranial Magnetic Stimulation (TMS) is contraindicated for patients with an implanted DBS System.
Electroconvulsive Therapy (ECT) – The safety of ECT in patients who have an implanted deep brain stimulation (DBS) system has not been established. Induced electrical currents may interfere with the intended stimulation or damage the neurostimulation system components resulting in loss of therapeutic effect, clinically significant undesirable stimulation effects, additional surgery for system explantation and replacement, or neurological injury.
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. MRI conditions that may cause excessive heating at the lead electrodes which can result in serious injury or death, or that may cause device damage, include: neurostimulator implant location other than pectoral and abdominal regions; unapproved MRI parameters; partial system explants (“abandoned systems”); misidentification of neurostimulator model numbers; and broken conductor wires (in the lead, extension or pocket adaptor).
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