What is a StrataMR device?
Medtronic StrataMR adjustable valves and shunts are used to manage hydrocephalus, a condition that affects the body’s ability to effectively manage the amount of fluid surrounding the brain.
The device works by draining cerebrospinal fluid (CSF) from the the brain, through a tube, into the heart. The StrataMR was designed to allow doctors to non-invasively adjust the device’s pressure using a magnetic tool. On, February 22 2017, Medtronic (the devices manufacturer) sent out an immediate Class II recall on the device urging doctors to immediately stop implanting StrataMR devices and to return any remaining devices. The recall notice also contained information on how to manage patients already implanted with the faulty device.
What is a hydrocephalus?
Hydrocephalus is a condition in which an abnormal amount of cerebrospinal fluid (CSF) accumulates within the brain, causing increased pressure inside the skull. Symptoms include headaches, double vision, poor balance, urinary incontinence, personality changes, or mental impairment. Less severe warning signs include vomiting, sleepiness, seizures and a downward pointing of the eyes. Babies and young children can see a rapid increase in head size from excess fluid. Hydrocephalus can be a birth defect as well as a condition developed later in life. It usually associated with meningitis, brain tumors, traumatic brain injury, intraventricular hemorrhage and subarachnoid hemorrhage. Hydrocephalus vastly increases the risk of brain injury and death.
How does StrataMR work?
The StrataMR device is a type of cerebral shunt manufactured by Medtronic. It is surgically implanted into the body in order to drain excess cerebrospinal fluid (CSF) from the head into the heart. The device features a magnetic adjustment valve designed to allow doctors to regulate pressure within the pump. The device has recently been linked to a number of serious injuries, prompting Medtronic to issue a Class II recall on the StrataMR unit.
FDA issues Class II StrataMR warning
The FDA recently issued a Class II recall / warning on StrataMR Adjustable Valves and Shunts. The federal agency urged doctors to:
- Discontinue use of the effected product
- Account for the number of product units implanted or discarded, and return any unused products
- Return unused products to Medtronic
- For any of the indicated products that have been implanted in patients, to see guided instructions for continuation of use
Who is at risk for StrataMR injury or death?
Anyone who has received a Medtronic brand implant to control hydrocephalus is urged to contact their doctor immediately in order to identify if their implant is affected by the Class II recall. The devices were manufactured between October 27, 2015 and November 11, 2016. These devices were distributed between January 7, 2016 and February 21, 2017. Approximately 1,796 devices are included in this recall, with over 40 lot numbers. At least one death has been reportedly linked to faulty Medtronic StrataMR devices.
What is being done for those injured by StrataMR?
There has been no clear-cut estimate as to how many people have been or will be injured by StrataMR adjustable valves and shunts. However, with close to two-thousand faulty devices in circulation, the threat of injury has been very real. Injured parties have begun to contact law firms like ours to discuss the possibility of pursuing litigation against the device’s manufacturer, Medtronic.