FDA approved this device under the Humanitarian Device Exemption (HDE) program. See the links below to the Summary of Safety and Probable Benefit (SSPB) and other sites for more complete information on this product, its indications for use, and the basis for FDA’s approval.
Product Name: Medtronic Activa® Dystonia Therapy
Manufacturer: Medtronic, Inc.
Address: 710 Medtronic Parkway N.E.
Approval Date: April 15, 2003
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf2/H020007a.pdf
What is it? A totally implanted brain stimulator to treat long-term primary dystonia (disordered muscle tone) that is not responsive to drug therapy.
How does it work? An implanted pulse generator (IPG) is connected with a lead (insulated wire) extension, to another lead with four electrodes. The electrodes are in contact with a specific structural area within the brain. The IPG is implanted under the skin of either the abdomen or under the collar bone, and sends programmable electrical stimulation pulses to the electrodes that were implanted in the brain. Two IPG device systems may be implanted, so that both sides if the brain can be stimulated to relieve symptoms on both sides of the body.
When is it used? The device is used in the management of long-term primary dystonia that is not responsive to drug therapy, in patients at least seven years of age.
What will it accomplish? It may improve some symptoms associated with primary dystonia. However, individual results vary and the specific benefit for an individual cannot be predicted.
When should it not be used? It should not be used in patients who will be exposed to diathermy, in patients who will be exposed to full-body MRI, or a head MRI.that extends over the chest, and in patients unable to properly operate the brain stimulator.
Additional information: The SSPB and Labeling is available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cftopic/pma/pma.cfm?num=H020007