In short
Back in February Medtronic, Inc. issued an Urgent Medical Device Correction notification relating to the use of potential damage associated with the lead cap provided in Medtronic Deep Brain Stimulation (DBS) lead kits and dystonia therapy kits. Now the U.S. FDA has classified the communication as a Class I Recall, its most serious category, despite the fact that no product is actually being recalled.
Background
DBS therapy uses a surgically implanted medical device to deliver mild electrical pulses to precisely targeted areas of the brain. The therapy is currently approved in many locations around the world, including Europe and the United States, for the treatment of the disabling symptoms of essential tremor, advanced Parkinson’s disease and chronic intractable primary dystonia, for which approval in the United States is under a Humanitarian Device Exemption (HDE).
Medtronic initiated its action after receiving 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.
So, what to do? 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.
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.
Source: FDA, Medtronic, Inc.
