Medtronic Deep Brain Stimulation Lead Cap Communication FDA Classification

BY Editor

Medtronic Deep Brain Stimulation Lead Cap Communication -May 03, 2013– Minneapolis, USA  (Techreleased) – In keeping with its commitment to keep physicians informed about product performance and safety, Medtronic, Inc.   issued an Urgent Medical Device Correction notification in February 2013 to provide physicians with information concerning the potential for deep brain stimulation (DBS) lead damage associated with the use of the lead cap provided in Medtronic DBS lead kits and dystonia therapy kits. The U.S. Food and Drug Administration (FDA) has classified the communication as a Class I Recall.

Medtronic

Medtronic has received reports of DBS leads being damaged due to twisting of the connector within the lead cap during the surgical procedure. The DBS lead cap is included in DBS lead kits and dystonia therapy kits and is sometimes used temporarily to protect the end of a DBS lead after it has been implanted. The DBS lead cap is not used in all DBS procedures, and is not permanently implanted. Depending on the extent of lead damage due to twisting of the connector during the placement and removal of the lead cap, lead replacement may be required or optimal therapy may not be achieved.

In the case of lead damage, if at the beginning of therapy patients are receiving therapy as expected, they are not likely to be affected by this issue. Patients with questions relating to this issue are encouraged to talk with their physicians.

A manufacturing change intended to address the issue is currently under FDA review, and in the meantime Medtronic has issued modified instructions to physicians who may use DBS lead caps.