Dystonia is a neurological movement disorder characterized by involuntary muscle contractions, which force certain parts of the body into abnormal, sometimes painful, movements or postures. Dystonia can affect any part of the body including the arms and legs, trunk, neck, eyelids, face, or vocal cords.
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• Dystonia is a neurological movement disorder characterized by involuntary muscle contractions, which force certain parts of the body into abnormal, sometimes painful, movements or postures.
•Dystonia can affect any part of the body including the arms and legs, trunk, neck, eyelids, face, or vocal cords.
• Abilities such as cognition, strength and the senses are normal in Dystonia sufferers, though speech can be impaired as a symptom.
•Dystonia is not fatal, but is a chronic disorder with often unpredictable prognoses.
•Dystonia is the third most common movement disorder after Parkinson’s Disease and Tremor.
•Dystonia does not discriminate: it affects people of every race and ethnic group and one-third of Dystonia patients are children.
•Dystonia affects more people than Muscular Dystrophy, Huntington’s Disease and Lou Gehrig’s Disease combined.
Medtronic: Class 1 Recall - Medtronic Deep Brain Stimulation Lead Kit and Activa Dystonia HDE Kit
AUDIENCE: Neurology, Nursing, Risk Manager, Surgery
ISSUE: Medtronic sent an Urgent Medical Device Correction letter to all affected customers notifying them of the potential for damage due to the use of the lead cap provided in DBS and Dystonia kits. Medtronic has received reports of DBS leads being damaged at the connector end of the lead when the lead cap is used. The connector end of the lead is the end of the lead connected to the lead extension. Tightening or loosening of the setscrew may twist the setscrew connector block and may damage the proximal connector end of the lead. If this happens, the damage would most likely occur at lead contact #3 which could affect electrode contact #3.Depending on the extent of lead damage and the need to use electrode #3, lead replacement may be required or optimal therapy may not be provided.
This recall covers 1,598 devices distributed in the United States between 04/2006 and 02/28/2013. Refer to the Recall Notice for a list of affected models.
BACKGROUND: The deep brain stimulation (DBS) system delivers electrical stimulation to selected targets in the brain. DBS leads are indicated for Dystonia, Essential Tremor, Obsessive-Compulsive Disorder, Parkinson’s disease, and epilepsy. Dystonia Therapy Kit is indicated for unilateral or bilateral stimulation of the internal globus pallidus or the subthalamic nucleus to aid in the management of chronic, intractable (drug refractory) primary dystonia including generalized and/or segmental dystonia, hemidystonia and cervical dystonia (torticollis).
RECOMMENDATION: If the lead cap is used during the implant procedure, customers should follow modified instructions (refer to the Urgent Medical Device Correction letter for details). For questions call Medtronic Neuromodulation Technical Services 1-800-707-0933. The firm is providing additional instructions for capping the lead and removing the lead cap and is not removing the product from market. There is no action required for existing patients in the absence of concern over potential lead damage.