Medtronic ordered to stop selling it
The US Food & Drug Administration (FDA) have catalogued problems with Medtronic’s SynchroMed pumps since 2006, but have now taken the drastic step to order the company to stop selling the pumps because of a failure to effectively address serious malfunctions that have been associated with death in some 14 cases.
These pumps can be used for the administration of intrathecal baclofen and some HSPers may be fitted with them.
UPDATE! The Therapeutic Goods Administration (TGA), Australia’s regulatory body for medicinal drugs and medical devices issued a press release in late May concerning the FDA’s banning of the Medtronic pump.
Here is an extract from the TGA’s press release:
The TGA is aware of regulatory action undertaken by the US Food and Drug Administration (FDA) in relation to the SynchroMed drug infusion system. The consent decree requires Medtronic to undertake the required actions globally and Medtronic Australasia will be implementing them in Australia from 15 June.The TGA is reviewing information supplied by Medtronic Australasia regarding this issue. The TGA will continue to monitor the safety and performance of SynchroMed drug infusion systems and will take appropriate regulatory action if a safety concern becomes apparent. In accordance with its usual procedures, the TGA will also continue to liaise closely with the FDA and other international regulators on this and similar issues.
The press release goes on to provide information for consumers and health professionals. Read the full press release from the TGA.
Below is extracted from 2 press releases in April in the USA:
MINNEAPOLIS _ Medtronic has entered an agreement with the Food and Drug Administration to stop selling an infusion pump except in rare cases because the company failed to fix manufacturing problems that may cause the implantable devices to deliver too much or too little medication.
The FDA on Monday announced the filing of a consent decree with the Ireland-based maker of medical devices, along with its chief executive Omar Ishrak and Thomas Tefft, president of the division that makes the Synchromed II implantable drug pump. The devices are made at a Minneapolis-area Medtronic’s plant.
The consent decree doesn’t say Medtronic is admitting liability, but it does halt most sales and manufacturing of the device until the FDA decides that the company has addressed the problems, first documented in 2006.
The agreement, which still requires court approval, allows the company to sell a device “in very limited cases,” including situations where a doctor determines the device is medically necessary for a patient’s treatment.
Medtronic spokeswoman Cindy Resman said that for patients who need a replacement pump, the company will have to get physician certification showing the patient has been informed about the FDA consent decree. For new patients, the certification must show that the patient knows of the agreement and the doctor still believes the benefits of the therapy outweigh the risks.
An announcement from the FDA said between 2006 and 2013, five inspections at the company’s neuromodulation plant resulted in three warning letters disclosing major violations involving the Synchromed II pumps, which were first approved for sale in 2004.
The violations included problems with how the company identified, investigated and corrected quality problems with the device, and its failure to document design changes. The company also failed to ensure the finished products met design specifications, the FDA said.
The failure to implement more rigorous manufacturing controls violated the rules in the federal Food, Drug and Cosmetic Act, turning the pumps into adulterated medical devices, the complaint for permanent injunction accompanying the consent decree says.
“Defendants are well aware that their practices violate the Act,” the complaint says. “FDA has repeatedly warned defendants, both orally and in writing, about their violative conduct, and has emphasized the importance the defendants’ compliance with the act.”
In June 2013, Medtronic acknowledged that 14 deaths had been associated with SynchroMed pumps since 1996. They included two people whose devices had blocks in the tube that delivers pain medication, and 11 cases in which the drugs were inadvertently injected into tissue around the pump rather than into its reservoir. One death was connected to a short-circuit in the device.
Word of the deaths came after the company told doctors about potential problems with the pump and issued special instructions for its use. The FDA later classified that communication as a Class I recall, which is the most critical type.
A Medtronic statement said the agreement, which is still subject to court approval, does not require the retrieval of any device, and patients with the pumps do not need to change their course of therapy. “We are committed to the highest level of quality, and have pursued significant efforts in recent years to enhance the performance of the pump and to address the FDA’s expectations,” Tefft said in a statement. “We are confident that our efforts to date will contribute to the timely and thorough completion of these activities.”
Physicians have long known about issues with the device, but they say there are few alternatives on the market. The FDA said Monday that problems with how the device is made can cause it to deliver too much or too little medication, or to delay therapy.
Monday’s FDA announcement said that between 2006 and 2013, five inspections at the company’s neuromodulation plant in Columbia Heights turned up violations of quality-control rules, resulting in three warning letters disclosing major violations in how the pumps are designed and made. “Defendants promised corrections at the conclusion of each inspection,” the FDA complaint says.
Medtronic, which moved its headquarters from Fridley to Ireland in January, has sold more than 230,000 of the devices worldwide since the first version was brought to market more than 25 years ago.
Star Tribune (Minneapolis, MN)
April 27, 2015
Star Tribune (Minneapolis, MN)
April 28, 2015
Many thanks for this article as I am booked into hospital next week to have the trial pump examination and if successful, I am booked in the following week to have the pump inserted. I will discuss urgently with my medical practitioners.
I have had the baclofen pump since around 1999 – I am not sure, but I was the second patient to receive a pump by Dr. McKenna in Las Vegas NV. A few years later, I had a pump refill at Christmas time by a Dr. Chin, the next day, I became violently ill and ended up in a hospital. Because of the holiday, Dr. Chin was unavailable and in desperation my husband called Dr. McKenna who came to the hospital immediately. He said it was a “medical emergency” and told us that some of the baclofen was injected into my -body-, not my pump. Whatever Dr. McKenna did, I recovered and never saw Dr. Chin again. In October 2015 I had the pump removed (the new surgeon left most of the delivery tube in my body because it was ‘rotten’ and broke!) – the reason I had it removed is because it was getting hard to get to Dr. McKenna’s office and also because it was time for the insertion of my SIXTH replacement pump. Well, I have been one and a half years without the pump and this is what has changed for me: 1. I have aged really fast, my skin has lost it’s firmness all over my body, 2. I am stiffer on my right side and sometimes I tremble for no reason. 3. I move much slower and I’m not steady. 4. I am almost 80 and for the first time in my life, I look it and feel it! Looking back and speaking as a vane woman, I wish I never made the decision to have the pump removed! I would be interested to having another one installed but it may be too late. I didn’t realize the side benefits of the pump. I miss it.
Can you tell me if there is any further update on this please. I had a pump replaced in Feb and it may be faulty by infusing too little baclofen.
Can you refer me to any reliable sources for this please.
Editor’s Note: The body charged with regulatory oversight of drugs, medicines and medical devices in Australia is the Therapeutic Goods Administration (TGA) and sister organisation in the USA where Medtronic is headquartered, the Federal Drug Administration (FDA).
Here is a link to the most recent update from the TGA, issued in December 2016: https://www.tga.gov.au/alert/medtronic-synchromed-ii-implantable-infusion-pump
And a link also to the most recent update from the FDA, issued in March 2017: https://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm546558.htm
Both these updates reference problems with over-infusion, which is the opposite of what you are experiencing. I also found this article which references the potential for both over and under-infusion due to software problems: http://www.fiercebiotech.com/medical-devices/medtronic-recalls-troubled-synchromed-infusion-pump
Your medical professionals should be fully aware of these updates from the regulatory authorities. You could ask them if they intend to report your issue to the TGA. If they do not intend to do so, and you are not satisfied with their rationale for that, you are able to report directly to the TGA yourself – the details for which are at the bottom of their advisory update.
Please come back and let us know what the root cause is, once identified, and what was done to correct the problem you are experiencing.
I have had a pump for baclofen since 2002. In 2008 my pump failed. I was on vacation in CA. My doctor in Oregon gave instructions to the doctors at Stanford on how to treat the withdrawl symptoms. I was a horrible experience. A new pump was placed. The pump helped me in that it greatly reduced my spasticity. But I did have a lot of back pain where the catheter was placed. This past year I have had so much improvement that I began decreasing my baclofen amounts gradually. Last week I had the final step of removing the remaining baclofen and replacing it with saline. As I walked out the door the nurse asked if I had any valium on hand incase of muscle cramping but I was given no other information on what I might expect after the baclfen left my body. By Monday night I was having excruciating, painful itching. When I checked in with the pain specialist nurse she said they had never heard of this being a withdrawl symptom and yet I had it the first time my pump failed. It is also the first thing mentioned on the card I received from Medtronics regarding “underdose” warnings. I also had a medtronics rep mention it last fall. I’m wondering if anyone has experienced this. I am going to try to call a medtronics nurse tomorrow. I’m using Atarax for itching or benaydrl and neither are working very well. I am concerned about having the pump removed because I always get spinal headaches. I have a very positive attitude but this needle sharp itching is very bad.
I also wonder why I have never heard of this withdrawl of these pumps. My last one was changed in 2012.