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Patients should always discuss the potential risks and benefits with a physician.
Medtronic Reclaim™ DBS Therapy for Obsessive-Compulsive Disorder*: 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).
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.
Placing the DBS system requires brain surgery, which can have serious and sometimes fatal complications including bleeding inside the brain, stroke, seizures, and infection. Once implanted, infection may occur, parts may wear through your skin, and the lead and/or extension connector may move. Medtronic DBS Therapy could stop suddenly because of mechanical or electrical problems. Any of these situations may require additional surgery or cause symptoms to return or worsen. Medtronic DBS Therapy may cause new or worsening neurological or psychiatric symptoms.
In patients receiving Medtronic DBS Therapy, depression, suicidal thoughts, suicide have been reported.
This therapy is not for everyone. Implantation of a DBS system is contraindicated (not allowed) for patients who will be exposed to diathermy (deep heat treatment) or transcranial magnetic stimulation. Magnetic Resonance Imaging (MRI) should only be performed as described in the product labeling. The DBS system may interact with other medical devices and other sources of electromagnetic interference which may result in serious patient injury or death, system damage or changes to the neurostimulator or to stimulation.
A prescription is required. Not everyone who receives DBS Therapy will receive the same results.
*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.