Medtronic recalled all StrataMR adjustable pressure valves after reports of one death and dozens of complaints about under-drainage of cerebrospinal fluid.
What You Can Do & How We Can Help
The Schmidt Firm, PLLC is currently accepting StrataMR induced injury cases in all 50 states. If you or somebody you know experienced a coma or symptoms of hydrocephalus, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Medical Device Litigation Group or call toll free 24 hours a day at (866) 920-0753.
What are StrataMR Valves?
StrataMR adjustable pressure valves are surgically implanted in the skull as part of a shunt system to relieve intracranial pressure. StrataMR valves control the drainage of cerebrospinal fluid through a tube in the abdomen, where the fluid is re-absorbed by the body.
What is Hydrocephalus?
StrataMR Valves and Shunts treat hydrocelphalus, a birth defect that causes too much cerebrospinal fluid inside the skull. The fluid puts pressure on the brain and causes swelling. Left untreated, hydrocephalus can cause permanent brain damage or death.
StrataMR Valve Recall
The FDA and Medtronic Neurosurgery (Brain Therapies) issued a Class I recall for all unused StrataMR Adjustable Valves and Shunts that drain fluid from the skull. According to an FDA 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?
Under-drainage of cerebrospinal fluid can occur if the StrataMR mechanism is adjusted to a position that causes too much flow-resistance. The problem can potentially lead to coma or death as pressure increases in the skull due to excess cerebrospinal fluid.
What is the Risk?
One death has been reported, although it is not clear if the death was caused by a malfunctioning StrataMR valve. As of April 1, 2017, the complaint-rate is 2.75% of the total number of units distributed, which suggests 72 complaints out of 2,622 StrataMR valves sold worldwide. They were made between October 27, 2015 and November 11, 2016.
Fixed-Pressure vs. Magnetic Shunt Systems
StrataMR valves are adjusted non-surgically with magnets. The valve is surgically implanted in the skull. A doctor uses a strong magnet on the back of the patient’s head and turns a dial to calibrate the valve. In comparison, older fixed-pressure shunt valves had to be carefully calibrated before they were surgically implanted in the patient’s skull. They could only be re-calibrated with a scalpel and another surgery.
What Products Were Recalled?
Recalled Product Name: StrataMR Adjustable Valves and Shunts.
Manufacturing Dates:: October 27, 2015 to November 11, 2016.
Distribution Dates: January 7, 2016 to February 21, 2017.
Number of Devices Recalled in the U.S.: 1,796 units.
Model Numbers: Valve, Small – 42955; Valve, Regular – 42965; Shunt Assembly, Small – 46955; Shunt Assembly, Regular – 46965, Snap Shunt Assembly, Small – 46960; Snap Shunt Assembly, Regular – 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
Patients and caregivers should be aware of the symptoms of hydrocephalus because they are similar to the symptoms of under-drainage of cerebrospinal fluid due to a defective StrataMR valve. The symptoms commonly found in infants and younger children 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
Hydrocephalus symptoms in older children, teens, and adults may include:
- Decrease in appetite
- Deteriorating mental capabilities
- Difficulty in walking
- Double vision
- Increased intracranial pressure
- Personality changes
Do I have a StrataMR Valve Lawsuit?
The Schmidt Firm, PLLC is currently accepting StrataMR valve induced injury cases in all 50 states. If you or somebody you know experienced a coma or symptoms of hydrocephalus, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Medical Device Litigation Group or call toll free 24 hours a day at (866) 920-0753.
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