Recall Z-1190-2013— 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 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.. 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.