April 11, 2017 — The FDA announced a voluntary recall for all Medtronic StrataMR shunt valve systems because they may fail to drain cerebrospinal fluid, resulting in coma or death.
Medtronic issued a Field Safety Notice (PDF) to surgeons on February 22, 2017 after receiving at least 72 complaints (2.75% complaint-rate). One person died, but it is not known if a defective valve was to blame.
StrataMR® adjustable pressure valves are surgically implanted in the skull of people with hydrocephalus, or “water on the brain,” a congenital condition in which too much cerebrospinal fluid causes brain swelling. It can cause permanent brain damage or death.
Strata valves control the flow of fluid from the skull through a tube into the abdomen, where the fluid is re-absorbed by the body. Unlike older shunt valve systems, Strata valves do not require surgery to be calibrated. Instead, they use magnets. The doctor places a magnet on the patient’s skull and turns a dial to adjust the valve.
The problem is that if the valves are calibrated to a position where they cause too much flow-resistance, cerebrospinal fluid will build up. Patients can suffer coma or death as pressure increases in the skull. The FDA issued a Safety Alert about the problem on April 8, 2017:
Under-drainage of cerebrospinal fluid may result in the following adverse health consequences: headaches, nausea, vomiting and lethargy. If left untreated, under-drainage can potentially lead to coma and death.”
The recall involves 2,622 shunts manufactured by Medtronic between October 27, 2015 until November 11, 2016. The recall involves model numbers 42955, 42965, 45905, 46955, 46960, 46965, and 46970.
Patients with the valves should contact their doctor immediately if they experience headaches, nausea, vomiting, lethargy, or symptoms of hydrocephalus. These may be signs of a malfunctioning shunt valve.
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