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Terminated

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 Recall Z-1190-2013 · Posted 2013-05-01

Recalling FirmMedtronic Neuromodulation
Recall StatusTerminated
Product CodeMHY
Date Initiated2013-02-08
Date Terminated2014-05-22
Product Quantity30,000

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

Firm 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.

Root Cause

Process control

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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