The FDA monitors reports of adverse events and other problems with medical devices and alerts the public when needed to ensure proper use of devices and protect the health and safety of patients and users. The FDA is issuing this safety communication to provide information to patients and health care providers about the risk associated with using deep brain stimulation (DBS) devices for Parkinson’s Disease during water-related activities (such as swimming) because of the loss of coordination while using the device. This information is timely as some states and communities reopen businesses during the COVID-19 pandemic.

Date Issued: July 30, 2020

The U.S. Food and Drug Administration (FDA) would like to remind patients and health care providers about the risk associated with using deep brain stimulation (DBS) devices for Parkinson’s Disease. Patients may be at risk of injury during water-related activities (such as swimming) because of the loss of coordination while using the device. Patients should also be cautious while bathing.

Important Recommendations for Patients and Caregivers

• Be aware that, although reported infrequently, when the device is turned on some patients with Parkinson’s Disease who use implanted DBS have noted difficulties in performing complex coordinated movements associated with swimming and may be at risk of drowning.
• Consult with your doctor before participating in water-related activities.
• Be aware that you may have difficulty performing water-related activities like swimming with your DBS device on even if you were an experienced swimmer before you received the device.
• You should not swim alone. When possible, consider having another adult with you in the water.
• Notify your health care provider if your symptoms get worse or you experience loss of coordination during water activities. Discuss your device’s settings with your health care provider and do not make any changes to your system without consulting your physician.

Recommendations for Health Care Providers

• Review the Important Recommendations for Patients and Caregivers with patients who have these devices.
• Discuss the risk of a loss of coordination involving several sequential movements in a coordinated fashion during swimming.
• Monitor for patient reports of loss of coordination during activities requiring coordination and report adverse events to FDA MedWatch program, using the information in the "Reporting Problems with Your Device."

Potential Safety Risk Associated with Deep Brain Stimulation (DBS) for Parkinson’s Disease

Parkinson’s Disease is a weakening and progressive disease process that affects the nervous system and impacts a person’s ability to perform motor tasks among other things. Many patients often take medication to find relief from symptoms. However, many patients suffer from changes in motor symptoms related to medical therapy; for such patients, deep brain stimulation (DBS) has proven to be a safe and effective option and has become a standard tool in the various treatments for Parkinson’s Disease.

Although the rate is unknown, FDA is aware of multiple reports of patients implanted with DBS for Parkinson’s experiencing difficulty swimming, including near and actual drownings. From adverse event reports received through our Medical Device Report (MDR) program since August 27, 2009, as well as recent publications in the medical literature, to date, FDA is aware of 16 patients implanted with DBS for Parkinson’s Disease who experienced difficulty swimming and/or a near-drowning event. We are also aware of 6 deaths reported in association with swimming activities, 2 patient deaths from drowning while in a bath tub and 2 patient deaths from drowning where the water activity was not specified.

These events included several patients with Parkinson’s Disease who were skilled swimmers prior to DBS device implantation. In some cases, the ability to perform coordinated swimming motions improved with reprogramming or temporarily turning the device off. However, at the current time, due to the small number of cases and limited information available, we are unaware of any associations with:

• specific lead positioning (Globus Pallidus Interna, Ventralis intermedius, Posterior Subthalamic Area);
• lead type;
• pattern of stimulation; or
• medication usage or changes in dosage regimen.

FDA Activities

The FDA is continuing to monitor reports and will update the public informed if significant new information becomes available.

Reporting Problems to the FDA

Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with medical devices. If you experience a problem with your device, the FDA encourages you to report the problem through the MedWatch Voluntary Reporting Form. Please include the following information to the extent possible in your report.

• Implant and stimulation location, including anatomical target and laterality of the DBS implant if known.
• Details on whether difficulties with activities or coordination were resolved by turning off the device or adjusting the stimulation settings.
• Date when you (or the patient, if reported by a third party) experienced difficulties with activities or coordination.
• Date of Parkinson’s Disease diagnosis.

Health care personnel employed by facilities that are subject to the FDA's user facility reporting requirements should follow the reporting procedures established by their facilities.

Contact Information

If you have questions, email the Division of Industry and Consumer Education (DICE) at [email protected] or call 800-638-2041 or 301-796-7100.