Medtronic has issued a worldwide recall over their unused StrataMR valve devices after numerous complaints have been raised.<\/p>\n
In one of the complaints, one patient death is suspected<\/em> to be related to the device. The Medicines and Healthcare products Regulatory Agency (MHRA) has issued an urgent Field Safety Notice to distribute news of the recall in the U.K. Approved less than one year ago, the StrataMR valves are used to relieve fluid pressure from the brain. It’s normally used in patients who suffer from a condition called hydrocephalus: an excessive build-up of cerebrospinal fluid. This water-like fluid acts like a cushion for the brain inside the skull. It provides physical and immunological protection for the brain. However, with too much of the fluid in their brain, sufferers of hydrocephalus are at risk of coma and even death.<\/p>\n The StrataMR valve implants were originally supposed to help drain the excessive liquid, relieving the pressure around the brain. However, the complaints alleged the devices didn’t work and led to an “underdrainage” of the cerebrospinal fluid. With the defective implants, patients with “underdrainage” are once again at risk of coma or death. Whilst one fatality has been linked to the implant, it has not been confirmed whether or not the valve is indeed the cause of the death.<\/p>\n The defect is related to the rotor mechanism being reportedly in the wrong position during the adjustment process of the device. “The incorrect valve rotor orientation can be caused by misalignment and\/or off centre positioning of the StrataMR Locator Tool, relative to the valve mechanism”. When the parts inside the device aren’t where they’re supposed to be, the pressure flow can be affected, and in effect the fluid drainage is reduced.<\/p>\n In the voluntary recall, the medical device makers have instructed patients to locate and return the unused devices back to Medtronic. It’s believed that between October 2015 and November 2016, around 2,622 of the affected devices were distributed worldwide. Other devices by Medtronic like Strata II and the Strata NSC hydrocephalus valves are not believed to be affected by the recall.<\/p>\n It is likely and expected that Medtronic will be conducting vigorous testing on more of their products to make sure they are all fit for purpose.<\/p>\n The MHRA issued an Urgent Field Safety Notice recalling the Medtronic StrataMR Adjustable Valves and Shunts. The Notice explains that patients with “underdrainage” may experience symptoms such as:<\/p>\n
\n<\/p>\nWhat are the devices used for?<\/h2>\n
The issue<\/h3>\n
The recall<\/h3>\n
Regulators issue notifications<\/h3>\n