Deep Brain Stimulation (DBS) device manufacturer Medtronic last week announced that the Food and Drug Administration (FDA) has issued a Class 1 Recall specific to a DBS lead cap, a tool which is sometimes used temporarily during the DBS implant procedure. The company has received reports of DBS leads (the electrodes implanted into the brain) being damaged due to the twisting of a part within the lead cap during this surgery.

Medtronic tells The Michael J. Fox Foundation (MJFF) that the reported adverse event occurs at a rate of 0.25 percent when a lead cap is used during surgery. The lead cap is a temporary installation which is not used in all DBS procedures (it’s employed about 20 percent of the time that the Medtronic technology is used, and is not permanently implanted). This means that the event cited by the FDA could occur about five times out of every 10,000 that DBS surgery is performed with Medtronic technology.

During these rare occurrences, the lead cap’s connector, which is used to protect the end of the lead after is has been placed in the brain, can get twisted. This can damage the lead itself. But physicians would likely immediately notice that the affected electrode wasn’t working properly, as they are able to monitor the amount of electricity being delivered into the brain in real time.   

Medtronic has submitted a manufacturing change designed to address the issue to the FDA, and these alterations are currently under review. The new changes have already been approved outside of the U.S., and the new device is already being delivered in certain countries.

The company has also issued new instructions for physicians who are using DBS lead caps. Some patients may need to have the lead itself replaced. Others might not be experiencing optimum therapeutic benefit because of the twisted wires. To date, there have been no reports of life-threatening impairment, or death, says Medtronic. If patients are receiving therapy as expected, they are not likely to be affected by this issue.

“The worst case scenario here is that less electricity gets into the brain, leading to less-than-optimal control of a person’s symptoms. In the best case, the technology works, which has already been proven to happen in more than 140,000 people,” explains Maurizio Facheris, MD, MSc, associate director of research programs at MJFF.

DBS is often used to effectively treat the symptoms of Parkinson’s disease (PD) but it may not be for everyone. It's important to talk about the procedure with a healthcare provider to discuss eligibility, and the pros and cons of having brain surgery.

Those individuals who are concerned about having already undergone DBS are encouraged to contact their physicians.