April 11, 2017 — Medtronic recalled all StrataMR shunt valves after one person died and dozens of complaints involving flow-resistance problems that can cause under-drainage of cerebrospinal fluid.
Medtronic Neurosurgery (Brain Therapies) initiated a voluntary recall for all unused lots of the StrataMR valve and shunt systems on February 22, 2017 in a Field Safety Notice (PDF) to surgeons.
The Strata® adjustable pressure valves are used to treat hydrocephalus, or “water on the brain,” a birth defect in which excess cerebrospinal fluid accumulates in the skull. The system drains fluid from the brain through a tube into the abdomen, where the fluid is re-absorbed by the body.
Older shunt valve systems must be carefully calibrated before they are surgically implanted. They can only be adjusted with another surgery. Unlike those older systems, Strata valves are adjusted with magnets.
The problem is that if the mechanism is adjusted to a position that causes too much flow-resistance, the patient can suffer coma or death as cerebrospinal fluid in the skull increases pressure on the brain.
There was one report of a patient who died, although it is not clear if the valve malfunctioned and caused the death. Medtronic says the complaint-rate is 2.75% out of 2,622 shunts, or around 72 complaints.
The FDA announced the recall on April 8 and issued the following Safety Warning:
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 StrataMR valves and shunts with model numbers 42955, 42965, 45905, 46955, 46960, 46965, and 46970. They were manufactured from October 27, 2015 until November 11, 2016.
The FDA recommends that patients who were implanted with the StrataMR shunts who experience headaches, nausea, vomiting, lethargy, or other symptoms of a malfunctioning shunt valve should contact the doctor who implanted the valve immediately.
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