The Food and Drug Administration has classified the recall of a deep brain stimulation device (DBS) as Class I, meaning that the agency believes there is “a reasonable probability” that the use of the product “will cause serious adverse health consequences or death.”
In an interesting twist, in response to the FDA’s warning Medtronic has denied that any patients with the device are in danger. DBS is used to treat conditions such as Parkinson’s disease.
The FDA issued the classification last week, a belated response to Medtronic Inc.’s Urgent Medical Device Correction notification in February, which warned physicians about “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.”
According to the FDA’s press release, Minneapolis-based 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, the FDA said. 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, according to the FDA. 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.
DBS therapy uses a surgically implanted medical device, similar to a pacemaker, 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.
Despite the FDA’s warning, on Friday Medtronic and two doctors maintained that no patient is in danger of dying because of the company’s DBS device, according to the Minneapolis Star Tribune.