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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC STRATA I VALVE REGULAR SIZE; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
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MEDTRONIC STRATA I VALVE REGULAR SIZE; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS Back to Search Results
Device Problems Break (1069); Defective Device (2588); Material Protrusion/Extrusion (2979)
Patient Problems Fatigue (1849); Fatigue (1849); Headache (1880); Headache (1880); Nausea (1970); Nausea (1970); Pain (1994); Pain (1994); Dizziness (2194); Discomfort (2330); Discomfort (2330); Ambulation Difficulties (2544)
Event Date 08/10/2016
Event Type  malfunction  
Event Description
On (b)(6) 2016, i had medtronic shunt put in my brain due to nph, within 3 months, i knew something was wrong as i was getting worse instead of getting better and had a shunt for 8 years and knew the symptoms of something wrong.My internist had a ct scan done and it showed the ventricles were very enlarged and he called my dr, dr.(b)(6) - my ns at (b)(6), as he was most concerned.Dr.(b)(6) did a procedure in his office and said my shunt was working and there was nothing he could do.I proceeded to get much worse but he would not see me and stated "there is nothing more i can do for you" and referred me to dr.(b)(6) at the same hospital.Since that time i have proceeded to get much worse and have called dr.(b)(6) who tried adjusting my shunt so that it would drain more.This seemed to work for about 2 weeks then i would end up with the same symptoms.Great fatigue, headaches (which i never had before) at night, terrible feeling of nausea during the day.The fatigue and lethargy were so bad i have spent most of the past year in bed, sleeping and barely making it through the day.It took every bit of will power and determination to just make it through the day.I feel terrible and feel great pressure in my head.I went to my internist again and again.He did a ct scan and again, it showed the ventricles too large and again he said i had to get to my ns immediately.At this time i have called my ns, dr.(b)(6) again and have had no response from him.I feel like he does not believe me but i am (b)(6) and i know something is terribly wrong with my shunt and that it is not working correctly.I am at the point where i can barely make it through the day, and my ns will not do anything.I am reporting that to you because i feel like my shunt is defective and i need help.My dr is simply not taking me seriously, but i know my medtronic programmable shunt is not working correctly, also three times now i have had little sharp things poke through my shunt area and they feel like little wires which are most painful when they start poling through the skin by where the shunt is, once through the skin the tiny sharp item then breaks off and the discomfort is gone but this had happened 3 times.At this point i do not know what to do as my dr is not taking me seriously.I have just learned that some of the medtronic shunts have been recalled and reading the symptoms leads me to believe i have a shunt tha thas been recalled.My headaches are bad and seem to be only at night but during the day.I feel great pressure in my head and just feel terrible.I do not know what medtronic shunt i have but dr.(b)(6) that put in my shunt on (b)(6) 2016 can be reached at (b)(6) and my number is (b)(6).I am at the point where it is so difficult for me to make it through the day.I feel so bad and i am one that rides my bike on the trails for 12 miles or 22 miles almost everyday, weather permitting.Please help me somehow.Thank you, (b)(6).
 
Event Description
Additional information received from report is that she did not have exact name of shunt when she initially made the first report.She however got in touch with (b)(6) from medtronic tel.Number (b)(6), reference number (b)(4), who advised, she has a strata i valve regular size shunt.This shunt was placed to manage hydrocephalus.Medtronic advised the only problem they were aware of was possible disintegration during mri.However, reporter has not had an mri and still experienced nausea, terrible headaches, fatigue, dizziness and ambulating difficulties.She felt like a year of her life was taken from her.Reporter wants the public to know of these side effects she experienced from this shunt.
 
Event Description
On (b)(6) 2016, i had medtronic shunt put in my brain due to nph, within 3 months, i knew something was wrong as i was getting worse instead of getting better and had a shunt for 8 years and knew the symptoms of something wrong.My internist had a ct scan done and it showed the ventricles were very enlarged and he called my dr, dr.(b)(6) - my ns at (b)(6), as he was most concerned.Dr.(b)(6) did a procedure in his office and said my shunt was working and there was nothing he could do.I proceeded to get much worse but he would not see me and stated "there is nothing more i can do for you" and referred me to dr.(b)(6) at the same hospital.Since that time i have proceeded to get much worse and have called dr.(b)(6) who tried adjusting my shunt so that it would drain more.This seemed to work for about 2 weeks then i would end up with the same symptoms.Great fatigue, headaches (which i never had before) at night, terrible feeling of nausea during the day.The fatigue and lethargy were so bad i have spent most of the past year in bed, sleeping and barely making it through the day.It took every bit of will power and determination to just make it through the day.I feel terrible and feel great pressure in my head.I went to my internist again and again.He did a ct scan and again, it showed the ventricles too large and again he said i had to get to my ns immediately.At this time i have called my ns, dr.(b)(6) again and have had no response from him.I feel like he does not believe me but i am (b)(6) and i know something is terribly wrong with my shunt and that it is not working correctly.I am at the point where i can barely make it through the day, and my ns will not do anything.I am reporting that to you because i feel like my shunt is defective and i need help.My dr is simply not taking me seriously, but i know my medtronic programmable shunt is not working correctly, also three times now i have had little sharp things poke through my shunt area and they feel like little wires which are most painful when they start poling through the skin by where the shunt is, once through the skin the tiny sharp item then breaks off and the discomfort is gone but this had happened 3 times.At this point i do not know what to do as my dr is not taking me seriously.I have just learned that some of the medtronic shunts have been recalled and reading the symptoms leads me to believe i have a shunt tha thas been recalled.My headaches are bad and seem to be only at night but during the day.I feel great pressure in my head and just feel terrible.I do not know what medtronic shunt i have but dr.(b)(6) that put in my shunt on (b)(6) 2016 can be reached at (b)(6) and my number is (b)(6).I am at the point where it is so difficult for me to make it through the day.I feel so bad and i am one that rides my bike on the trails for 12 miles or 22 miles almost everyday, weather permitting.Please help me somehow.Thank you, (b)(6).
 
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Brand Name
STRATA I VALVE REGULAR SIZE
Type of Device
SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
Manufacturer (Section D)
MEDTRONIC
MDR Report Key6587068
MDR Text Key75967463
Report NumberMW5069984
Device Sequence Number1
Product Code JXG
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial,Followup
Report Date 05/23/2017
1 Device was Involved in the Event
2 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received05/23/2017
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received05/26/2017
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number0
Patient Outcome(s) Other;
Patient Weight61
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