As most of you reading this may already know that for 22 years I have dealt with chronic back pain for an accident caused by a drunk driver and I apologize for doing it, again however with recent court orders I feel it’s necessary for everyone to know all the details of a product before trying one out. For just about 15 years of that I have had in my abdomin a Medtronic Pain Pump which 24/7 is dripping a narcotic directly into my spine to help control my pain. In that time I have had numerous issues with the pump which included but not limited to,
- The pump running out of medicine before its scheduled to.
- The pump not running at the speed it set for causing a large amount to be left in the pump when it should be time to refill it.
- Catheter end inside my spine clogging up causing reduced flow rate.
- Battery in pump lasts 5-6yrs and needs replacing. At one of these replacement surgeries, the device was inserted upside down causing no access to the fill port. 45 days after the insert surgery I had to have a “flip the pump over” surgery.
- When the pump was close to (4-5 days) it’s due date to be refilled there were times my body would go into withdrawals and oral meds did not help.
- Every 40-50 days the pump needed to be refilled via a needle inserted into refill port, left over meds removed and then a known amount (20cc) inserted and device reset with new amount.
- And the piece de resistance, Sept., 2013 I was in for a pump refill and when the doctor pulled back on the syrenge handle to remove the left over med (Fentynal, 100x more potent then Morphine) they pulled the needle tip out of the pumps fill port. When they went to refill the unit, the full 20cc of Fentynal was pushed directly into my abdominal tissue causing a major overdose. Which put me in the ICU for three days and the hospital another two.
We were even told by several lawyers that we approached, because my case was workers comp. related that there was nothing we could do, even though there we previous cases with the same issues and others even worse, deaths. Just recently in our local newspaper, The Sacramento Bee printed the following article pertaining to the internal pain management pump,
“April 27, 2015,
FDA: Medtronic must stop most sales of Synchromed drug pumps.
The Food and Drug Administration says Medtronic must stop most sales of its implantable drug pumps after years of uncorrected problems. The FDA has filed a court order against Medtronic that says the medical device giant must halt most production and distribution of its Synchromed II drug pumps, which are implanted devices used to treat patients with cancer, chronic pain and severe muscle spasms. Among other defects, some Synchromed pumps had to be recalled because they could lose battery power and fail, endangering patients. In other cases, the devices could cause patients to receive too much or too little medication. Medtronic generally did not recommend that patients have the devices removed, unless they were proven to be failing.
The devices are surgically implanted and deliver a drug solution to the area surrounding the spinal cord. They are prescribed for patients who do not respond to oral medications or who experience severe side effects when taking them. Medtronic said the agreement allows the company to make some drug pumps available on a limited basis to physicians. The Minneapolis-based company stressed it is not announcing any new recalls or safety alerts about its products.
“Patients with the Synchromed drug infusion system do not need to change their current course of therapy, have the pump removed, or take any other action as a result of this agreement,” Medtronic said in a statement.
The FDA’s consent decree was filed in the U.S. District Court of Minnesota and awaits the signature of a federal judge. The government says that Medtronic CEO Omar Ishrak and neuromodulation business chief Thomas Tefft sold medical devices that failed to meet federal manufacturing standards, enforced under the Food, Drug and Cosmetic Act.
A consent decree is a form of legal settlement in which a company agrees to court-ordered actions without admitting fault or guilt. The decree will remain in effect until the FDA determines Medtronic has fixed the problems outlined in the document. Medtronic will be legally required to hire an outside expert to help correct the problems. “Defendants are well aware that their practices violate the Act,” states the government filing. “FDA has repeatedly warned defendants, both orally and in writing, about their violative conduct.” The FDA issued the company three warning letters about quality control and manufacturing problems at its drug pump facility in Columbia Heights, Minnesota between 2006 and 2013. FDA inspectors visited the plant five times over that period, the agency said in a Monday statement.
- Medtronic plc is the world’s largest medical device company, specializing in implantable pacemakers, defibrillators, drug pumps and other medical equipment. Last year the company completed a $43 billion acquisition of Ireland’s Covidien. The company now has its executive offices in Dublin, where it benefits from Ireland’s lower corporate tax rates. The settlement was announced concurrently by the FDA and the U.S. Justice Department. Shares of Medtronic plc fell $1.40, or 1.8 percent, to close at $76.21.”
Before all this even we checked into having the device removed and go with just oral medications until something else could be found to treat the pain, surprisingly no one would take me due to “workers compensation.” And everyone was saying that, “There’s nothing that can come close to what the internal pump can do for your type of pain.” OKAY, so what do I do? My device is one that has the potential of doing more harm than good. One that has a mind of its own and works intermittently depending on its mood of the day.
I’m still unsure of how I am going to proceed from this point on. So far we have been searching for just about 2 to 2-1/2 years for something and will continue to do so. If Medtronics were to approach me with the option for a buy out and they’ll remove the unit and I just handle the pain management on my own, I think I would have to take it, with Trish’s input of course. Please feel free to respond to this with your thoughts on this issue. I look forward to reading any and all comments.