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