​FDA Warns That Magnetic Interference May Occur between Programmable Cerebrospinal Fluid Shunt Systems and Hearing Implants That Contain Magnets

July 24, 2019 | Risk Management News

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ECRI Institute's complete weekly summary of medical device hazard and recall information is available in ECRI Institute's Health Device Alerts. For more information contact us at clientservices@ecri.org.

In a July 16, 2019, Letter to Health Care Providers, FDA states that magnetic interactions between programmable CSF shunt systems and some hearing implants that contain magnets, such as cochlear implants, bone conduction hearing devices, or middle ear hearing devices, can occur when they are implanted in close proximity to each other. The magnetic interference can cause unintended changes to the programmable CSF shunt valve settings. Unintended changes to the programmable CSF shunt valve settings may lead to over-drainage or under-drainage of CSF. These problems could cause patients to experience symptoms such as altered mental status, headaches, lethargy, irritability, vomiting, changes in vision, and difficulty walking. If symptoms are left untreated, they could progress to include loss of consciousness, seizures, hemorrhage, or death. Previously, FDA posted information about magnetic field interference with programmable CSF shunt valves and potential...

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