Medtronic Addresses FDA Recall for Strata™ II/Strata™ NSC and StrataMR™ valves

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Medtronic StrataMR Shunt SystemDiscussion on social media around the FDA notification regarding the Strata™ II/Strata™ NSC and StrataMR™ valves has led to a number of questions from patients. There are two actions currently being taken by the FDA and Medtronic to address issues with each of these products respectively.

Strata™ II/Strata™ NSC Valves

Medtronic has proactively implemented a Field Corrective Action (FCA) for its Strata™ II/Strata™ NSC valves. This type of FCA is referred to by the FDA as a ‘Class II Recall’. No actual shunt products are being “recalled” by Medtronic from the medical community.  The FCA involves Medtronic updating their Instructions for Use (IFU) to make providers aware of a rare condition related to the Strata Valve that can lead to an inaccurate pressure level (PL) reading on the Strata™ Indicator Tool or StrataVarius™ system.  The condition occurs only if a patient has been exposed to 3T MRI magnetic field or greater, and if biological debris is present to an extent that the valve magnet adjustment mechanism is impacted. This recall was initiated as a result of reported problems with the shunts in patients which occurred at an extremely low incident rate. Moving forward, new instructions will include this information in the packaging so medical professionals are aware as they monitor their patients after shunt surgery.

StrataMR™ Valves

Medtronic has also made a proactive decision to physically recall StrataMR™ valves still in stock at hospitals and medical facilities. This is to address an issue where the valve pressure level may be higher than anticipated. Medtronic is not recommending patients with the StrataMR™ have the valve removed. All providers currently using the valve have been provided with instructions to monitor existing patients with StrataMR™ valves. If you have a Medtronic StrataMR™ valve, you may have already received a communication directly from your neurosurgeon or neurologist. Please follow the advice you are being sent in this letter.

Many of you are undoubtedly asking what these recalls mean to you.

First, it is important to know what type of shunt valve(s) you have and, if programmable, its current setting. We recommend recording this information in a place that is easily accessible, like our HydroAssist® mobile app or on a Patient Shunt Card you can carry in your wallet (available from your neurosurgeon or Medtronic).

Second, as is the case with most programmable shunts, your setting can change following an MRI procedure. If you are scheduled for an MRI procedure, or need to undergo an emergency procedure, always make sure that your shunt settings are checked and verified afterwards by your neurosurgeon or neurologist.

Three, if you currently have the StrataMR™ valve, be aware of any changes to how you are feeling and notify your neurosurgeon or neurologist if you have any concerns.

It is important to note that the Medtronic Delta® fixed-pressure valve and CSF-Flow Control valves are not included in this recall. The Strata™ II/Strata™ NSC valves were first made available in the U.S. beginning in February, 2002. The StrataMR™ valve was first made available in the U.S. beginning in June, 2016.

Medtronic has indicated that they will be posting a statement on these field corrective actions shortly.

 

Click HERE to read Medtronic’s press release.

12 Comments for : Medtronic Addresses FDA Recall for Strata™ II/Strata™ NSC and StrataMR™ valves
    • Andrea
    • March 10, 2018
    Reply

    My daughter has a strata 2 valve in place- we are currently in the hospital for shunt malfunction symptoms. This all originated from having cox sackies virus in November- where she had a dull headache with malaise for 2 days and had a Grand Mal seizure the next day. Where she was seen in the ER and admitted for 3 days blaming the seizure on a UTI as the head CT was normal. She does have epilepsy but never had a Grand Mal seizure before. Then she had another episode which was a ? seizure where she was really left in a daze- where she started to become confused and acting strangely – intermittent headaches.. we had been seen by the neurologist and had an EEG which was essentially negative. At that time symptoms started with dizziness then headache on the shunt side and then would start having ataxia. At that time I visited the Neurosurgeon and they had said the shunt is working fine. We went back to the neurologist where he ordered an MRI. The results didn’t show enlarged ventricles. We went back to the Neuro surgeon to reprogram the shunt valve back to 1.5 with the wand and was told the shunt was fine. It was thought that the symptoms she had was viral encephalitis from Cox sackie in November. Since the MRI in January her symptoms worsened and became more frequent until everyday. Where the Neurosurgeon needed to check the shunt. He checked open and closed pressures from a LP which were normal. No culture was sent. Symptoms worsened and it was decided to admit her and place a ICP monitor and EEG monitoring at the same time.. so EEG was cleared- although other seizure meds were added. They were going to take her to surgery to explore the shunt until the ICP monitor came undone. The PA removed it and stapled her head. The valve setting was changed from 1.5 to 2 and she left . Advised if she has more changes or deteriorated she would need to come in. We still continued having the same symptoms but every time we ambulated and headache would worsen. During the night she became extremely symptomatic and her O2 sat dropped to 58%. The PA was called in she readjusted the valve setting back to 1.5 with the magnet device and then drew fluid off to prove the shunt was working. Her headache immediately went away and then was told surgery was off… well she continued to be more symptomatic with O2 desaturation when getting up and headache , dizziness with throbbing up her neck when she gets up. We had every specialist come in to see her and everything points back to the shunt. Then we decided to have a 2nd opinion from another Neuro surgeon- they ordered a X-ray for valve setting since that was really the only true way of knowing. We found out that the setting was still 2 where it was reset at 1.5- then I dug a little deeper to see the recall on the strata 2 . Due to her having viral encephalitis there could be debris to malfunction the valve. The Neuro surgeon was notified and refuses to come in stating he has signed off. Now we have been admitted for 10 days and no Neuro surgeon. Awaiting for a transfer to Mayo or Shands for a neurosurgeon there to take her..,

    • Jose Batista
    • November 16, 2017
    Reply

    I think it’s ridiculous that we even have to worry about this they need to come up with something to rectify the situation with her tree placement and removal.

      • Jose Batista
      • November 16, 2017
      Reply

      Whether it’s a replacement or removal all together. I had mine put in April 4 of 2017 I’ve never had one before but I know for sure that I don’t like it I don’t like the way it makes me feel it’s very unpredictable and it’s been extremely hard just trying to just live a halfway normal life. That is whatever “normal “is anymore?

  1. Reply

    Please be aware that the Strata Valve Regular 1 (Medtronic REF-92866 can cause sever problems without an MRI ever being done. I have one and it is definitely defective and has caused me great grief and a year of my life lost to terrible symptoms of: Nausea, headaches at night, terrific fatigue and lethargy, feeling so bad I could hardly make it through the day. A year of my life has been taken away from me due to this shunt. If you have experienced any of these problems with this shunt please contact the FDA immediately.

      • Becky ickes
      • July 9, 2017
      Reply

      Me too!! Ditto!

    • Reply

      My valve has been giving me issues with requiring resetting. My symptoms have been dull headache, lethargy, nausea and issues with sight ( pressure in eyes. ) Are these the same symptoms others have had? My doctor re-sets the valve but it only seems to work for 6 months and I am back for another round of resetting. I am having a hard time at work. What is solution to issue?

    • Daquasha Smith
    • April 23, 2017
    Reply

    I have been experiencing nausea nausea headache loud buzzing soundsnear my shunt behind my ear pressure in the head and behind the ear I went to my surgeon and he just keep telling me that it would take time for my body to adjust once the strata shunt move from a 1.point to 1.5 I felt like I was dying what can I do to make them understand this is a everyday pain buzzing in my ear every day I’m feeling this what can I do to convince them that this is real and pain meds dont help they only make u sleep.I have had the strata shunt six month there had berm no relieve chest pain and shortness of breath.

      • Robin Espinoza
      • August 8, 2017
      Reply

      I am sorry for your issues. I think they are common to all types of shunts. I have a Codman shunt since 2009 and my neurosurgeon is going to replace it with a Strata. I hope the symptoms improve for both of us!

    • William James Mason
    • March 27, 2017
    Reply

    I’m getting really worried about this issue. I’ve been having symptoms but not told my doctor because my family doctor called me a liar about having hydrocephalus.

      • Judy Hamby
      • March 29, 2017
      Reply

      I was diagnosed with NPH in 2005 after several months of going from doctor to doctor – none of which had a clue to my problem. I even went to a psychiatrist – – his first question….”Are you having an affair?” We finally found a wonderful neurosurgeon in charlotte, NC. In 2005 I had a Codman shunt inserted into my brain – AT LAST! I see my NS two times a year. My big question is – How long will my shunt continue to do “His/Her” job? How often should shunts be replaced?

    • Mike Stasinopoulos
    • March 15, 2017
    Reply

    How do I know if my strata II Valve is working correctly

    • Patricia Hakes
    • March 14, 2017
    Reply

    1. If the valve is giving an inaccurate reading on the Medtronic Strata Varius or indicator tool, how is the Dr. supposed to check the reading? That tool is what my Dr. uses to check the shunt setting. What are they supposed to use now that we know the indicator tool is not always reliable?

    2. What is biological debris and how can it get into the shunt valve or affect the shunt performance or reading? How can we or the Dr. know if biological debris is present?

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