Interventional Spine &Pain
Scheduling 419 522 1100 Fax 419 522 4118
POSITION STATEMENT on RECALLS: We are more than aware of the "recalls" and “warnings” from medical device manufacturers. Every piece of equipment used by ISPROC, Dr Stretanski is inspected and tested as best as is possible. Every patient with an implantable technology is followed long-term and is provided with Dr Mike's personal cell phone. Most of these "recalls" are really about silly things like making sure you implant the device completely and/or make sure you fill it in the center port. Up to this point we feel these "official warnings" seem to just be legal mumbo jumbo written by the manufacturer’s lawyers who want to sound important to their own bosses and so far our patients should really not worry. That being said, there is a reality that every machine eventually breaks down - this is true of cars, computers and something as simple as an ink pen or as complex as a pain pump. When and if there is a failure, we will deal with it at that time.
Please do not panic or believe the media hype you see on the news – we have had a ZERO failure rate with both Medtronic and Codman pumps. Also understand the reality that news/radio and media in general are paid to create drama and they are covering the news about the corporate lawsuit, not the care of the patient. Also understand that different companies make pumps and stimulators, so they will sling mud and say bad things about each other like Coke vs. Pepsi or any group of car manufacturers. And while some of this is just creative advertising, patients can be frightened by info that is simply not true, and they just want their competitors to just go away.
Patients with an implant need to know that one manufacturer might go as far as to call the patients who have been implanted by their competitor and tell them they have an emergency and need the current pump or stimulator taken out and replaced with their device – this is telemarketing, intimidation and fear mongering at its most unethical form. Please report any such calls to us so we can forward that information to the state attorney general as well as try and figure out how your personal information got into the hands of another company.
If there was any real problem with this technology, we would call you in and Dr Mike would stop inserting these devices. We review and follow the official FDA warnings carefully. The truth is that any piece of technology can fail - it can be as simple as an ink pen or as complex as a computer - when and if that were to ever happen to a pain pump, Dr Mike has a protocol in place to replace the pump and a back-up physician if he were to ever be unable or more than a day out of town. The likelihood of anything like this is very tiny. The other reality is that pumps are a solid state battery with a finite life. At every interrogation of the pump it reports what will be the ERI or elective replacement interval. This is not a "low battery" signal but rather a count down to what will be a low battery.
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Spinal Cord Stimulators, "Dorsal Column Stimulators"
As an intervention for chronic back and/or leg pain, spinal cord stimulation can be an effective alternative or adjunct treatment to other therapies that have failed to manage pain on their own.
An implantable system delivers electrical pulses via a lead to nerves in the dorsal aspect of the spinal cord. Pain signals are inhibited before they reach the brain and replaced with a tingling sensation (parasthesia) that covers the specific areas where the pain was felt.
A new technology called AdaptiveStim® reduces the need for patients to manually adjust their stimulation parameters when changing positions. AdaptiveStim, exclusively available with RestoreSensor®, recognizes and remembers the correlation between a change in body position and the level of stimulation needed. It records and stores the frequency of posture changes, providing feedback to clinicians to help understand how a patient’s stimulation requirements change over time.
A function of AdaptiveStim called AdaptiveStim Diary provides objective dataregarding patient activity. Clinicians can use this data to assess, evaluate, and optimize a patient’s neurostimulation experience.