Important Safety Alerts

This is an update to the safety alert on "Deep Brain Stimulators in Parkinson's Patients" issued on 31 July 2020.

Medical device manufacturer, Boston Scientific Corporation, has issued a medical device safety alert concerning its Deep Brain Stimulators (DBS).

In July 2020, FDA issued the safety communication, which was intended 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 device. Patients should also be cautious while bathing."

During the same period, FDA had been working with all DBS manufacturers in United States to standardize the language about this information in the Instructions for Use (IFU)s.

A manufacturer, Boston Scientific Corporation, is in the process of updating the IFUs with the content outlined below:

Addition to Patient IFUs

• Activities Requiring Coordination: Loss of coordination is a possible side effect of DBS therapy. They should use caution when doing activities that require coordination, even if they were able to do them before receiving therapy.
• Bathing: They should exercise reasonable caution when bathing.

Addition to Physician IFUs

• Patient Activities Requiring Coordination: Loss of coordination is a potential side effect of DBS therapy. Patients should exercise reasonable caution when participating in activities requiring coordination, including those that they were able to perform prior to receiving DBS therapy (e.g., swimming).
• Bathing: Patients should exercise reasonable caution when bathing.

Upon review of the July 2020 FDA communication, the Korea Ministry of Food and Drug Safety has requested all manufacturers to disseminate the information to the healthcare professionals. Therefore, the purpose of the manufacturer's safety communication is to provide users with the FDA communication as well as share the update that is being made to the Boston Scientific DBS IFUs. Affected users are advised to note that the indications and contraindications of the devices remain unchanged.

According to the manufacturer, no product batch/lot is being recalled in relation to the IFU updates. Additionally, the manufacturer has not received any reports of this type in their post-market surveillance activities. Affected users are advised to discuss this important information with the patients and any relevant person.

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

Posted on 21 September 2020