Medtronic recalled all StrataMR valves due to a flow-resistance problem that could cause under-drainage of cerebrospinal fluid, coma, and other serious injuries or death.
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Medtronic Neurosurgery (Brain Therapies) manufactures StrataMR Adjustable Pressure Valves & Shunt Systems for the treatment of hydrocelphalus, or “water on the brain,” a congenital disorder that causes excess cerebrospinal fluid in the skull.
Complications of Hydrocephalus
Hydrocephalus causes a build-up of fluid in the cavities deep within the brain called ventricles. The ventricles become very swollen as fluid accumulates, which puts pressure on the brain, increases the size of the skull, and causes severe brain damage. Treatment involves draining off excess cerebrospinal fluid to relieve intracranial pressure.
StrataMR Valve Recall
Medtronic issued a Class I recall for StrataMR Valves because a design flaw may result in under-drainage of cerebrospinal fluid and symptoms of hydrocephalus. The FDA issued a Safety Warning in April 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.”
What is the Problem?
The StrataMR valve mechanisms can be adjusted to an incorrect position that causes fluid flow-resistance problems. This can result in under-drainage of cerebrospinal fluid and the return of hydrocephalus symptoms as pressure gradually increases inside the skull.
What is the Risk?
One death was reported in a patient with a StrataMR valve, but it is unknown if the death was caused by a device malfunction. As of April 1, 2017, the complaint-rate is 2.75%, or approximately 72 complaints out of the 2,622 units distributed worldwide since January 7, 2016.
StrataMR Magnetic vs. Fixed-Pressure Valves
StrataMR valves are unique because they use magnets to calibrate the flow of cerebrospinal fluid. The doctor simply places a strong magnet on the back of the patient’s head and turns the dial to adjust it. In comparison, traditional fixed-pressure valves had to be carefully calibrated before they were surgically implanted in a patient’s skull, and adjusting it required another surgery and the use of a scalpel.
Recalled Product Information
Medtronic issued an Urgent Field Safety Notice to warn surgeons about flow-resistance problems with StrataMR valves on February 22, 2017. The recall involves the following products:
- StrataMR Adjustable Valves and Shunts
- Manufacturing Dates: October 27, 2015 to November 11, 2016.
- Distribution Dates: January 7, 2016 to February 21, 2017
- 1,796 units recalled in United States
- Model Numbers 42955, 42965, 45905, 46955, 46960, 46965, and 46970
- Lot Numbers E03581, E03582, E04352, E04353, E05120, E05121, E06015, E06016, E06138, E06139, E06412, E06476, E09475, E09619, E11655, E11656, E12041, E12265, E12266, E12272, E12273, E12556, E12620, E12752, E12753, E12779, E12780, E12932, E12933, E12934, E12935, E12950, E12951, E12952, E12953, E13482, E13483, E13484, E13485, E13573, E13576, E13641, E13698, E14270, E14518, E14519, E14748, E16247, E18555, E18556, E18557, E18558, E18559, E18560, E19084, E19540, E19670, E19671, E19866, E19867, E22208, E22242
Symptoms of Hydrocephalus and Fluid Under-Drainage
The symptoms of hydrocephalus are similar to the symptoms of fluid under-drainage due to a defective StrataMR valve or shunt system. In young children and infants, these symptoms may include:
- Distended scalp veins
- Downward gaze (sometimes called “sunset eyes”)
- Enlargement of the head
- Enlarged and bulging fontanel
- Feeds poorly/Decrease in appetite
- High-pitched cry
- Recurrent vomiting
In adults and older children, the symptoms may include:
- Decrease in appetite
- Deteriorating mental capabilities
- Difficulty in walking
- Double vision
- Increased intracranial pressure
- Personality changes
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The Clark Firm has assembled a team of trial lawyers with more than 100 years experience, participation in over 600 jury trials and $260 million in verdicts and/or settlements. Please use the form below to contact our Texas StrataMR valve lawyers for a free lawsuit review.