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Medtronic DBS Lead Kit for Deep Brain Stimulation, models… recallZ-1190-2013 · Medtronic Neuromodulation · initiated Feb 8, 2013

Class I Terminated All recalls posted in May 2013

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Medtronic Neuromodulation or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

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

FDA root cause category: Process control

What the company is doing

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.

Recall details

Recall number
Z-1190-2013
Recall class
Class I (most serious)
Status
Terminated
Initiated by the company
Feb 8, 2013
Posted by the FDA
May 1, 2013
Recalling firm
Medtronic Neuromodulation
Quantity
30,000
Product code
MHY
FDA submissions
P960009
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.

Product description

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 (models, lots, serial numbers)

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.

Other devices under the same FDA submission

90 devices cleared under P960009 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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