Important Safety Alerts

The United States Food and Drug Administration (FDA) has issued a safety communication concerning the risk of loss of coordination during water-related activities in Parkinson's patients with Deep Brain Stimulators (DBS).

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, DBS has proven to be a safe and effective option and has become a standard tool in the various treatments for Parkinson's Disease.

The FDA would like to remind patients and health care providers about the risk associated with using 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 devices. Patients should also be cautious while bathing. Although the rate is unknown, the FDA is aware of multiple reports of patients implanted with DBS for Parkinson's Disease experiencing difficulty swimming, including near and actual drownings.

The FDA is giving the following 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 doctor before participating in water-related activities.
• Be aware that patients may have difficulty performing water-related activities like swimming with the DBS device on even if patients were an experienced swimmer before received the device.
• Patients should not swim alone. When possible, consider having another adult in the water.
• Notify health care provider if symptoms get worse or experience loss of coordination during water activities.
• Discuss the device's settings with health care provider and do not make any changes to the system without consulting physician.

FDA is also giving the following recommendations for health care providers:

• Review the recommendations for patients and caregivers of patients who have these devices.
• Discuss the risk of a loss of coordination involving several sequential movements in a coordinated fashion during swimming.

For details, please refer to the following link:
https://www.fda.gov/medical-devices/safety-communications/risk-loss-coordination-during-water-related-activities-parkinsons-patients-deep-brain-stimulators

If you are in possession of the affected products, please contact your supplier for necessary actions.

Posted on 31 July 2020