—#116147

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.

FDA product code: MHY — Stimulator, Electrical, Implanted, For Parkinsonian Tremor
Device class: Class 3
Medical specialty: Unknown
PMA numbers: P960009
Affected lot / code info: 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.

Why it was recalled

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

Root cause (FDA determination)

Process control

Action the firm took

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.

Recalling firm

Firm: Medtronic Neuromodulation
Address: 7000 Central Ave NE, Minneapolis, Minnesota 55432-3568

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2013-02-08
Posted by FDA: 2013-05-01
Terminated: 2014-05-22
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #116147. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.