Important Safety Information DBS THERAPY FOR DYSTONIA

OVERVIEW

Medtronic DBS Therapy for Dystonia: Patients should always discuss the potential risks and benefits with a physician.


INDICATIONS

Unilateral or bilateral stimulation of the internal globus pallidus (GPi) or the subthalamic nucleus (STN) using Medtronic DBS Therapy for Dystonia is indicated as an aid in the management of chronic, intractable (drug refractory) primary dystonia, including generalized and/or segmental dystonia, hemidystonia, and cervical dystonia (torticollis), in patients seven years of age or above.


Contraindications

Medtronic DBS Therapy 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 they have an implanted Soletra™ Model 7426 Neurostimulator, Activa™ SC Model 37602 Neurostimulator, or Model 64001 or 64002 pocket adaptor.


Warnings and Precautions

There is a potential risk of brain tissue damage 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 cardiac pacemakers or therapies, cardioverter/ defibrillators, external defibrillators, ultrasonic equipment, electrocautery, or radiation therapy. MRI conditions that may cause excessive heating at the lead electrodes which can result in serious 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). The safety of electroconvulsive therapy (ECT) in patients receiving DBS Therapy has not been established. Tunneling the extension too superficially or too deeply may result in nerve or vascular injury, or tunneling through unintended anatomy. The lead-extension connector should not be placed in the soft tissues of the neck due to increased incidence of lead fracture. 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). Onset of status dystonicus, which may be life-threatening, may occur during ongoing or loss of DBS therapy. Loss of coordination in activities such as swimming may occur. Depression, suicidal ideations and suicide have been reported in patients receiving Medtronic DBS Therapy, although no direct cause-and-effect relationship has been established.


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 and weight gain or loss.

Safety of this device for use in the treatment of dystonia with or without other accompanying conditions (e.g., previous surgical ablation procedures, dementia, coagulopathies, or moderate to severe depression, or for patients who are pregnant) has not been established. Age of implant is suggested to be that at which brain growth is approximately 90% complete or above.


Humanitarian Device

Authorized by Federal Law as an aid in the management of chronic, intractable (drug refractory) primary dystonia, including generalized and/or segmental dystonia, hemidystonia, and cervical dystonia (torticollis), in patients seven years of age or above. The effectiveness of the devices for treating these conditions has not been demonstrated.

USA Rx only

Rev 11/17