Deep Brain Stimulus Devices May Cause Loss Of Coordination In Parkinson’s Patients, FDA Warns

Individuals with Parkinson’s disease who have undergone deep brain stimulation procedures may face an increased risk of drowning or suffering a serious injury while performing water-related activities, according to a new warning issued by federal regulators, which highlights the potential for loss of coordination that may occur suddently.

The U.S. Food and Drug Administration (FDA) issued a Safety Communication this week, warning patients with Parkinson’s disease who use implanted deep brain stimulation devices to exercise caution during when partaking in water-related activities, such as swimming or even bathing.

Parkinson’s disease affects more than 500,000 Americans, with approximately 50,000 new cases each year. It is a brain disorder that affects the nervous system and impacts the individual’s ability to perform motors tasks, often leading to increased imbalance and shaking. In severe cases, some patients lose all motor function. There is no known cure for the disease, which is the 14th leading cause of death in the U.S.

While some patients with little to mild symptoms are able to use medications to find relief, many patients suffer from significant changes in motor symptoms, in which Deep Brain Stimulation (DBS) is often recommended.

DBS device implantation is similar to a pacemaker, but used in the patient’s brain. It is a surgical procedure where electrodes are implanted in the brain to deliver electrical impulses to precise locations to treat Parkinson’s disease, dystonia and as well as refractory epilepsy. Although the treatment is beneficial in many ways to patients, one of the side effects is patients may experience sudden losses of coordination.

The warning was issued after the FDA became aware of multiple water-related fatalities and injury reports involving Parkinson’s patients with implanted DBS devices.

Although the exact rate of this occurrence for Parkinson’s patients with implanted DBS is unknown, at least 16 near or actual drownings including six swimming deaths, two bath tub drownings, and two unknown water-related activity deaths have been reported to the FDA’s Medical Device Report (MDR) program since August 27, 2009.

According to the warning, several of the fatal adverse reports involved patients who were skilled swimmers prior to DBS device implantation.

The agency is warning that patients with implanted DBS may be at an increased risk of injury or death during water related activities because of sudden loss of coordination.

Patients are being encouraged to speak with their healthcare provider before participating in water-related activities and be aware that even a previously experienced swimmer with DBS could be at risk of drowning. The agency is recommending patients never swim alone and always have an adult present.