Worldwide Distribution - USA Nationwide and the countries of: Algeria, Australia, Austria, Belarus, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Jordan, Korea, Latvia, Lebanon, Lithuania, Luxembourg, Malaysia, Malta, Mexico, Morocco, Netherlands, New Zealand, Norway, Peru, Philippines, Poland, Portugal, Puerto Rico, Romania, Russian Federation, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Venezuela, Viet Nam.ġ A record in this database is created when a firm initiates a correction or removal action. The Medtronic Rep documented the hospital visits on an Account Specific Customer Confirmation Form and left a copy with the Hospital. On JMedtronic representatives began visiting the identified accounts to facilitate removal of any unused product. UPDATE: Medtronic mailed an Urgent: Medical Device Removal notification to customers on June 07, 2013, who may have unused DBS lead kits that were manufactured prior to the process change to correct the issue. For questions call Medtronic Neuromodulation Technical Services 1-80. The letter instructed customers to follow the modified instructions if the lead cap is used during the implant procedure. The letter identified the affected product, problem and actions to be taken.
Medtronic sent an Urgent Medical Device Correction letter dated February 2013 to all affected customers. Tightening or loosening of the setscrew may twist the setscrew connector block and may damag The connector end of the lead is the end of the lead connected to the lead extension. Medtronic has received reports of DBS leads being damaged at the connector end of the lead when the lead cap is used. There is a potential for lead damage due to the use of the lead cap provided in DBS and Dystonia kits. Medtronic is providing Additional Instructions for Capping the Lead and Removing the Lead Cap. Sterile and Non-Pyrogenic.ĭystonia Therapy Kit is indicated for unilateral or bilateral stimulation of the internal globus pallidus (GPi) or the subthalamic nucleus (STN) to aid in the management of chronic, intractable (drug refractory) primary dystonia, including generalized and/or segmental dystonia, hemidystonia, and cervical dystonia (torticollis).Īll product is affected as the lead kits are not being removed from the market. Medtronic DBS Therapy for Dystonia Kit, models 3317, 3319, 33.
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Implanted subcortical electrical Stimulator (motor disorders) - Product Code MRU Class 1 Device Recall Activa Dystonia Therapy Kit
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