Reported May 8, 2013 · Terminated
Medtronic DBS Therapy for Dystonia Kit, models 3317, 3319, 3337 and 3339. Sterile and Non-Pyrogenic. Product Usage:…
Medtronic Neuromodulation
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Medtronic Neuromodulation · 7000 Central Ave NE · Minneapolis, MN · 55432-3568
Is this the product you have?
Medtronic DBS Therapy for Dystonia Kitmodels 331733193337 and 3339. Sterile and Non-Pyrogenic
- Product UsageDystonia 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)
- Lot codes and dates
- 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.
- Amount recalled
- 30,000
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
- PR
Why it was recalled
Stop using this product now
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
Using this product could cause serious injury, illness or death — stop using it now.
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