Indications, Safety, and Warnings
Brief Statement: Reclaim™ DBS Therapy for OCD
Product labeling must be reviewed prior to use for detailed disclosure of risks.
INDICATIONS*: 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: Medtronic Reclaim™ DBS Therapy for OCD is contraindicated for patients who are unable to properly operate the neurostimulator. The following procedures are contraindicated for patients with DBS systems: diathermy (e.g., shortwave diathermy, microwave diathermy or therapeutic ultrasound diathermy), which can cause neurostimulation system or tissue damage and can result in severe injury or death; Transcranial Magnetic Stimulation (TMS); and certain MRI procedures 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 the patient has an implanted Soletra™ Model 7426 Neurostimulator, Kinetra™ Model 7428 Neurostimulator, Activa™ SC Model 37602 Neurostimulator, or Model 64001 or 64002 pocket adaptor.
WARNINGS: 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 brain tissue damage and other side effects using stimulation parameter settings of high amplitudes and wide pulse widths. Extreme care should be used with lead implantation in patients with an increased risk of intracranial hemorrhage. Sources of electromagnetic interference (EMI) may cause device damage or patient injury. 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. The DBS System may be affected by or adversely affect medical equipment such as implanted cardiac devices (e.g., pacemaker, defibrillator), external defibrillation/cardioversion, ultrasonic equipment, electrocautery, or radiation therapy. MRI conditions that may cause excessive heating at the lead electrodes which can result in serious and permanent injury including coma, paralysis, 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). Abrupt cessation of stimulation should be avoided as it may cause a return of disease symptoms, in some cases with intensity greater than was experienced prior to system implant (“rebound effect”).
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, and sensations such as tingling, smell, or taste. During treatment, patients should be monitored closely for increased depression, anxiety, suicidality, and worsening of obsessive-compulsive symptoms.
Patients should avoid activities that may put undue stress on the implanted components of the neurostimulation system. Activities that include sudden, excessive or repetitive bending, twisting, or stretching can cause component fracture or dislodgement that may result in loss of stimulation, intermittent stimulation, stimulation at the fracture site, and additional surgery to replace or reposition the component. Patients should avoid manipulating the implanted system components or burr hole site as this can result in component damage, lead dislodgement, skin erosion, or stimulation at the implant site. Patients should not dive below 10 meters (33 feet) of water or enter hyperbaric chambers above 2.0 atmospheres absolute (ATA) as this could damage the neurostimulation system, before diving or using a hyperbaric chamber, patients should discuss the effects of high pressure with their clinician.
PRECAUTIONS : The safety of somatic psychiatric therapies using equipment that generates electromagnetic interference (e.g., vagus nerve stimulation) has not been established. Loss of coordination in activities such as swimming may occur.
ADVERSE EVENTS : Adverse events related to the therapy, device, or procedure can include intracranial hemorrhage, cerebral infarction, CSF leak, pneumocephalus, seizures, surgical site complications (including pain, infection, dehiscence, erosion, seroma, and hematoma), meningitis, encephalitis, brain abscess, cerebral edema, aseptic cyst formation, device complications (including lead fracture and device migration) that may require revision or explant, extension fibrosis (tightening or bowstringing), new or exacerbation of neurological symptoms (including vision disorders, speech and swallowing disorders, motor coordination and balance disorders, sensory disturbances, cognitive impairment, and sleep disorders), psychiatric and behavioral disorders (including psychosis and abnormal thinking), cough, shocking or jolting sensation, ineffective therapy, sensory symptoms, autonomic symptoms and weight gain or loss.
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 than 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, who are 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.
*Humanitarian Device: : Authorized by Federal 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 the devices for this use has not been demonstrated.
