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U.S. Department of Health and Human Services

Class 1 Device Recall Deep Brain Stimulation Lead Kit

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 Class 1 Recall
Deep Brain Stimulation Lead Kit
see related information
Date Posted May 01, 2013
Recall Status1 Terminated on May 22, 2014
Recall Number Z-1190-2013
Recall Event ID 64439
Premarket Approval
PMA Number
P960009
Product Classification Stimulator, Electrical, Implanted, For Parkinsonian Tremor - Product Code MHY
Product Medtronic DBS Lead Kit for Deep Brain Stimulation, models 3387, 3387S, 3389, 3389S, 3391, 3391S. Sterile and Non-Pyrogenic. Product Usage: The deep brain stimulation system delivers electrical stimulation to selected targets in the brain. DBS Leads are indicated for Dystonia, Essential Tremor (ET), Obsessive-Compulsive Disorder (OCD), Parkinsons Disease (PD), and epilepsy.
Code Information all product is affected as the lead kits are not being removed from the market. Medtronic is providing Additional Instructions for Capping the Lead and Removing the Lead Cap.
Recalling Firm/
Manufacturer
Medtronic Neuromodulation
7000 Central Ave NE
Minneapolis, Minnesota 55432-3568
For Additional Information Contact Technical Services
763-514-2000
Manufacturer Reason
for Recall
There is a potential for lead 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 damag
FDA Determined
Cause 2
PRODUCTION CONTROLS: Process Control
Action Medtronic sent an Urgent Medical Device Correction letter dated February 2013 to all affected customers. The letter identified the affected product, problem and actions to be taken. The letter instructed customers to follow the modified instructions if the lead cap is used during the implant procedure. For questions call Medtronic Neuromodulation Technical Services 1-800-707-0933. 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. On June 10, 2013 Medtronic representatives began visiting the identified accounts to facilitate removal of any unused product. The Medtronic Rep documented the hospital visits on an Account Specific Customer Confirmation Form and left a copy with the Hospital.
Quantity in Commerce 30,000
Distribution 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.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
PMA Database PMAs with Product Code = MHY and Applicant = MEDTRONIC INC.
PMAs with Product Code = MHY and Applicant = MEDTRONIC NEUROLOGICAL
PMAs with Product Code = MHY and Applicant = MEDTRONIC VASCULAR
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