MAUDE Adverse Event Report: CODMAN & SHURTLEFF CODMAN BACTISEAL SHUNT SYSTEM

Catalog Number 82-3072

Device Problems Break (1069); Detachment Of Device Component (1104); Defective Device (2588); Infusion or Flow Problem (2964)

Patient Problems Fatigue (1849); Headache (1880); Nausea (1970); Pain (1994); Swelling (2091); Discomfort (2330); Complaint, Ill-Defined (2331); Sleep Dysfunction (2517); Lethargy (2560)

Event Type  malfunction  

Event Description

On (b)(6) 2016, i had a medtronic shunt put in my brain due to nph, within 3 months i knew something was wrong as i was getting worse instead of better and had a shunt for 8 years and knew the symptoms of something wrong.My internist had a cat scan done and it showed the ventricles were very enlarged and he called dr.(b)(6) my ns at (b)(6) in (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 and during all day.The fatigue and lethargy were so bad i have spent most of the past year in bed sleeping and barely marking 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 cat 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 this 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 poking 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 has 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 that has 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 the 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).

• Brand Name: CODMAN BACTISEAL SHUNT SYSTEM
• Type of Device: SHUNT
• Manufacturer (Section D): CODMAN & SHURTLEFF
• MDR Report Key: 6600802
• MDR Text Key: 76436265
• Report Number: MW5070070
• Device Sequence Number: 1
• Product Code: JXG
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 10/31/2018
• Device Catalogue Number: 82-3072
• Device Lot Number: CTNBAN
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Weight: 61