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 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?
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