The U.S. Food and Drug Administration (FDA) is issuing a safety communication to provide information to patients and healthcare 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, states an agency press release.
The U.S. Food and Drug Administration (FDA) would like to remind patients and healthcare 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 include:
· 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 healthcare provider if your symptoms get worse or you experience loss of coordination during water activities. Discuss your device’s settings with your healthcare provider and do not make any changes to your system without consulting your physician.
Recommendations for Healthcare Providers include:
· 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, the 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, the 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, two patient deaths from drowning while in a bathtub and two 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.
The FDA is continuing to monitor reports and will update the public informed if significant new information becomes available.
