I really feel for chronic pain patients. Over the course of my 32 years in practice, I have seen so many fine folks who are in pain 24/7/365. The lives of chronic pain patients center around what they can do to get relief. They often look to anything that can help reduce or relieve their pain.
Medical technology has entered the pain field and offered many solutions to pain patients, that are alternatives to powerful and highly addictive narcotics. Medtronic designed an implantable pain pump that would deliver medication directly to the patient at pre-set intervals. This could have several advantages, including providing consistent levels of medication and avoiding the risk of the patient accidentally over-medicating or over-dosing themselves.
The pump was designed to be implanted directly into the patient’s abdomen and connected internally by a catheter to the intrathecal space of the spine. In this way, the medication can be directly targeted to the pain receptors in the spine. The pump was only approved for use in certain patient populations and with certain drugs. For example, it could be used to deliver morphine for the treatment of intractable chronic pain or methotrexate for the treatment of pain associated with primary or metastatic cancer. As well, it was approved for delivery of Baclofen for treatment of severe spasticity.
However, the Medtronic Synchromed II Pump has faced many problems, leading up to an FDA recall. According to the FDA, Medtronic was required to recall the SynchroMed II pump, because “a software problem may cause unintended delivery of drugs during a priming bolus procedure, used to quickly deliver a large dose of medication from the device to the patient’s spine.” During this time, patients may also “receive the drug unintentionally at a high rate of infusion in the cerebrospinal fluid followed by a period of reduced drug delivery after the priming bolus.
During this time, patients may also “receive the drug unintentionally at a high rate of infusion in the cerebrospinal fluid followed by a period of reduced drug delivery after the priming bolus.
Other problems which have been observed with the pumps include:
- Motor stalls.
- Catheter becomes clogged.
- Catheter disconnects from the pump.
- Battery dies prematurely.
- Soft ware misdirects the amount of medication.
- Pump short-circuits.
- Priming bolus fails.
Sadly, a malfunctioning pain pump can lead to a host of problems, including delivery of a fatal drug overdose to the unsuspecting patient!
The FDA, reacting to complaints, conducted multiple inspections of Medtronic’s manufacturing facilities between 2006-2013 and revealed many concerns. Part of the problem was the way in which Medtronic dealt with complaints about devices that were reported to have malfunctioned or caused serious injury to a patient. AS the FDA stated, the manufacturer is required to investigate and implement changes under these circumstances. But, the FDA didn’t stop there. They asked the Justice Department to get involved. That led to DOJ filing a complaint which alleged that Medtronic and two of its senior executives had been distributing medical devices into interstate commerce that were adulterated because they were not manufactured in accordance with current good manufacturing processes. The DOJ action led to a consent decree in which Medtronic and its leadership committed to make changes in their process that will “benefit the American public by ensuring that their products are safe and effective for patients.” According to counsel for the DOJ, “The DOJ will not permit medical device manufacturers to shirk their responsibility to ensure that the devices that patients rely upon are safe.” I say, GO DOJ!
“The DOJ will not permit medical device manufacturers to shirk their responsibility to ensure that the devices that patients rely upon are safe.” I say, GO DOJ!
In conclusion, I suppose this isn’t the first time you’ve heard about a defective medical device and I can almost promise you it won’t be the last. As patients, we have very little control over what products are put inside our bodies and we therefore, must place extreme trust in corporations who manufacture these products. Unfortunately, we see time and time again, that corporations are perfectly willing to put profits over patient safety until they are forced to stop and made to pay for the harm they have caused.
Don’t you wish the bad behavior would end so that I would run out of things to write about? Until then, friends and colleagues, stay safe out there! Kay Van Wey
Comments 4
I’m canceled my third pain pump due to prior failures and massive scar tissue.do no get it. Move wrong once and the medication goes no ware. It’s all about the money
I had a Medtronic Pain Pump since July 2000, several replacements over the years with one complete catheter revision about 15yrs. ago. Several weeks ago my Dr. did a dye study on my pump and thought he found a kink at the pump site. This past year or so when the he would drain my pump he would get way too much medicine out and was still at a high rate of pain and at 15mcg. I have a type of Neuropathy and have had all types of meds thru my pump before finally getting Preilat. Today I had a surgeon remove my pump, which was due to be renewed and since my catheter had blown a hole in it, he left the old one in place and put in a new one. In the past the other surgeons removed the old catheter before placing new one. I’m asking is this a new common practice now among surgeons? I already haven pieces of the blown cath. floating around in my body as it is, I really don’t like the idea of having an extra non-functioning item in my spine. I would appreciate a response. Respecfully, Concerned in Arkansas
I got a medtronic pump around 3 years ago. It made me go septic. After they put a new one in it worked fine until 3 months ago. I kept telling every dr i saw i was in so much more pain. Here the stupid pump had an issue with the catheter. It put me in the hospital due to my blood pressure rising so high (243/160) because of the pain. To top it off they wouldn’t give me pain meds because of the pump. I found out the pump was at fault when at my pump fill they pulled 35ml out of a 40ml pump.
I had a medtronic pain device serial#NGV708001H Model#8637-40 implanted 21-Oct-2019 and taken out Oct. 2020 due to a malfunction. The morphine and lidacaine leaked into my veins and paralyzed me almost completely! If my pain Doctor hadn’t come to hospital and put me in ICU I wouldn’t be writing you this letter now! He found the problem and drained the medicine out of my body and what was left in the pump. The agony I felt and still feel was to say the least was excruciating, not to mention what my husband and family went through! My eyes aren’t the same, my eye Dr. said it’s from the paralysis. Needless to say I’m back on opioids again and the pain is much worse! I didn’t realize how much pain the pump helped me until it was gone! I never want to go through this again and will never have another pump or device put into me again! I’ve gone through physical therapy but still walk with a cane. Medtronic has not got back to the Dr. or myself to explain what went wrong. I want to be compensated for my near death experience and the pain I must endure for the rest of my life!! Any advice from you would be appreciated! thank you, sincerely Terri Theodore