Medtronic announces FDA Class I recall of deep brain stimulation lead cap

180

Medtronic has issued an Urgent Medical Device Correction notification in February 2013 to provide physicians with information concerning the potential for deep brain stimulation lead damage associated with the use of the lead cap provided in Medtronic DBS lead kits and dystonia therapy kits. The US Food and Drug Administration (FDA) has classified the communication as a Class I Recall.

Medtronic, according to a company release, has received reports of deep brain stimulation leads being damaged due to twisting of the connector within the lead cap during the surgical procedure. The lead cap is included in deep brain stimulation lead kits and dystonia therapy kits and is sometimes used temporarily to protect the end of a deep brain stimulation lead after it has been implanted. The deep brain stimulation lead cap is not used in all deep brain stimulation 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, Medtronic advised, 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 deep brain stimulation lead caps.

Any malfunctions or adverse events related to a device should be reported to Medtronic Neuromodulation Technical Services at 1-800-707-0933, and the FDA’s MedWatch Program at www.fda.gov/MedWatch.