Recall Z-1191-2013— Medtronic Neuromodulation

Class I FDA medical device recall by Medtronic Neuromodulation, initiated 2013-02-08, terminated 2014-05-22. FDA's recall record names no specific 510(k) clearance for this event. Product: Medtronic DBS Therapy for Dystonia Kit, models 3317, 3319, 3337 and 3339. Sterile and Non-Pyrogenic. Product Usage: Dystonia 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).. Reason: 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.

Recalling firm

Medtronic Neuromodulation

Classification

Class I

Status

Terminated

Initiated

2013-02-08

Terminated

2014-05-22

Firm location

Minneapolis, MN, United States

Data sourced from openFDA. This site is unofficial and independent of the FDA.