Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with medical devices.
- If you suspect a problem with a CSF shunt, we encourage you to file a voluntary report through MedWatch, the FDA Safety Information and Adverse Event Reporting program.
- 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.
- Device manufacturers must comply with the Medical Device Reporting (MDR) regulations.
To help us learn as much as possible about the adverse events associated with unintended changes in magnetic externally adjustable CSF shunt valve settings please include as much information in your report as possible. The following provides the type of information that is helpful to the FDA, but if this information is not available, it is still helpful for you to submit a report with the information you do have:
- Details of the valve setting change event, including the suspected distance of the shunt from the magnetic source if known
- Identify the suspected magnetic source(s)
- Severity of patient symptoms
- Change in valve setting value from intended setting
- Manufacturer and brand of magnetically adjustable shunt
- Patient age, gender, underlying diagnosis for shunt (e.g. trauma, hydrocephalus)
- Concomitant medical devices in region of shunt (i.e. cranial plate, cochlear implant)
- Device evaluation post-explant, if available
If you have questions about this communication, please contact the Division of Industry and Consumer Education (DICE) at DICE@fda.hhs.gov, or 800-638-2041, or 301-796-7100.