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Ely
Ely, Counselor at Law
Category: Legal
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Experience:  Private practice with focus on family, criminal, PI, consumer protection, and business consultation.
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Regarding recent warnings and numerous complaints concerning

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Regarding recent warnings and numerous complaints concerning the medical device, the "Medtronic Interstim Neurostimulator for the Bladder" over the preceding 5-7 years. Serious adverse events reported included SEVERAL instances of fractured leads resulting in malfunctioning, misfiring, and in some cases complete blockage of ANY impulse, thus rendering the device non-functional putting patients at risk for multiple issues (more info available). Also, another common reported adverse event were frequent unexpected "electrical shocks," which were painful, and occurred most often in the lower extremities. Many of these left permanent and documented nerve damage.The focus has been on the Sprint Fidelis leads (cardiac), dismissing, or barely covering ( despite the FACT multiple cases have been reported by patients, some seeking a class action lawsuit) the other "faulty leads." Are you familiar with this widespread issue of faulty leads in the Medtronic Interstim Device?? Thank you for your time, and I look forward to hearing from you... Susan, Texas "


 


P.S. Just wanted to add I am aware and have been following the House Bill 1346 that was


put in place some years back in reaction to the multiple reported cases of malfunctioning (some with life threatening "shocks") Sprint Fidelis leads in the Medtronic cardiac device. 


This HB affected all Medtronic devices as well.


 


Thank you

Hello, my name is Ely. I am here to help you. There may be a slight delay between your follow ups and my replies as I type out a reply. Please note: (1) this is general information only, not legal advice; and (2) my function is to give you honest information and not to tell you what you necessarily wish to hear.

I am a Texas-based expert and am familiar with the matter above. What is it that you are trying to know/achieve here, exactly, please?

This not an answer, but an Information Request. I need this information to answer your question. Please reply, so I can answer your question. I look forward to helping you.
Customer: replied 4 years ago.

Thank you for your response. I will try to verify my inquiry. Since late 2008, I have become keenly aware, and joined the ranks of hundreds ( likely many more) of patients who now have chronic conditions, as a result of a malfunctioning/faulty "lead" (documented in medical records of the lead fracture) as a result of the device in question, the Interstim by Medtronic. In many cases the Interstim leads fractured just as the Sprint Fidelis leads did resulting in a series of unscheduled, and sadly, for some of the cardiac patients, deadly "shocks." Are you aware (as I am) of the recent requests and comments by the FDA requesting more detailed reporting by Medtronic in solving the multiple complaints from patients regarding various devices, most recently the Syncromed Pain Pump issues? The Interstim has been reported hundreds of times to Medtronic, the FDA (available on line), and two very popular websites, which have endless and detailed depictions of adverse patient experiences, many with devastating outcomes.My question is, "Do you see on the horizon, anything changing in the pursuit of


justice for damages received as a result of a fractured lead in Medtronic's Interstim device?


 


Thank you,


 


Susan Texas


Are you aware (as I am) of the recent requests and comments by the FDA requesting more detailed reporting by Medtronic in solving the multiple complaints from patients regarding various devices, most recently the Syncromed Pain Pump issues?

Yes, I am. There has also been talk of a class-action lawsuit. This is a known problem:

http://www.aboutlawsuits.com/medtronic-synchromed-battery-problems-19504/

Do you see on the horizon, anything changing in the pursuit of justice for damages received as a result of a fractured lead in Medtronic's Interstim device?

Yes, I do. Actually, you do not need to wait for any specific legislation in order to seek a civil suit against the manufacturer of a faulty device. If you or someone you know has been injured here, then the manufacturer is liable for strict liability, which is actionable in Court.

If the care taken by the supplier of a product in its preparation, manufacture, or sale of a product is below par and leads to injury in the use for what it was intended for, then the manufacturer is liable. Turner v. General Motors Corp., 584 SW 2d 844 - Tex: Supreme Court 1979 (General discussion).

So you do not have to wait for a statutory relief via the bill, but pursue the manufacturer in Court NOW.

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