Medtronic Pain Pump Failure Cases
Our Lawyers Handle Medtronic Pain Pump Failure Cases
At Devereaux, Stokes, Nolan, Fernandez & Leonard, we handle cases of Medtronic pain pump failure on behalf of people throughout Missouri, southern Illinois, and Colorado.
If you have had a Medtronic Synchromed, Synchromed II, Isomed or intrathecal implantable infusion pain pump implanted into your body call us immediately and speak to one of our lawyers to determine if your pain pump was the subject of a recall and what your options may be.
Our local St. Louis area number is 314.450.7874. You can also reach us toll free at 866.634.5292.
Who is Medtronic and what is a Pain Pump?
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Medtronic is a medical device manufacturer that has a large percentage of the pain pump market share in the United States. Infusion pumps are devices that are surgically implanted into the patient's abdomen. Inside the pain pump is a reservoir your doctor can fill with medication, as well as a programmable motor that can deliver medication from the reservoir into a long tube or catheter which runs from the pump to the intrathecal space surrounding the patient's spinal cord. The pump works by delivering medication from the pump directly to the nerve receptors in the spinal cord on a set schedule thereby helping control pain and spacisity.
There are 3 general classes of patients that use infusion pumps. The most common are those suffering from chronic pain. Infusion pumps are also used by patients receiving baclofen therapy. Baclofen is a muscle relaxant used to help control spacistisity related to multiple sclerosis, spinal cord injuries and other neurological disorders. Infusion pumps are also used by cancer patients to help administer chemotherapy medication.
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Is there a Problem with the Medtronic Infusion Pain Pumps?
Certain doctors have recently been seeing particular pain pumps manufactured by Medtronic fail at an alarming rate. This is not the first time Medtronic has had a problem with their infusion pain pumps. There is a history of problems and recalls related to these infusion pumps.
In August of 2007 a recall was initiated by the FDA on Medtronic Inc. Synchromed EL implantable infusion pumps. The reason given for the recall was that there was a danger of the pump motors stalling on pumps that were manufactured prior to 1999. Five months later in January of 2008 another recall was issued on Medtronic Neuromodulation SynchroMed EL, SynchroMed 2 and IsoMed implantable infusion pumps. This time the reason for the recall was that there was a problem with some patients forming inflammatory masses or granulomas at the tip of the catheters.
Now the public and doctors are being told of yet another problem with Medtronic pain pumps. Medtronic has advised doctors using their products that certain Medtronic Synchromed II pumps were manufactured without propellant. This defect in the manufacturing process can lead to unknown drug concentrations, inconsistent or variable therapy results, withdrawal symptoms, lack of therapeutic effect and clinically significant drug overdose.
Medtronic is recalling all of the affected pumps that have not yet been implanted. They are also recommending that patients who have a defective pump already implanted undergo surgery to have the pump replaced.
What does an FDA recall mean?
Medical device manufacturers such as Medtronic are required to report "adverse events" of which they become aware to the FDA. If the FDA believes a product is defective or poses an unreasonable risk to patients they may negotiate with the manufacturer to pull the product from the market, a voluntary recall, or they can order the manufacturer to immediately notify doctors of a problem with the device and order that the product be recalled. Because these pain pumps are actually implanted into the human body they are considered to be a Class I medical device by the FDA and should be subject to stricter safety standards.
For detailed information about the FDA recall of Medtronic infusion pain pumps visit the official FDA website.
What is the danger to me?
If you have a Medtronic infusion pain pump implanted in you that is defective it could stop working without warning. It could also dilute the medication in your reservoir leading to an underdose or overdose of medication. Medtronic has warned that this can result in withdrawal symptoms, inconsistent or variable therapy results and even death in the case of intrathecal baclofen therapy patients. Call our firm in St. Louis, Missouri, to speak to an attorney about your options.
What do I need to do?
If you have a Medtronic infusion pain pump the first thing you should do is contact your doctor to verify whether your pump is defective or the subject of any of the Medtronic recalls. Your doctor is the best person to discuss your treatment options with you.
In the event you do have a defective pump we can help evaluate whether you may be entitled to compensation from Medtronic. Call our offices to speak to an attorney or fill out the Pain Pump failure evaluation form below and one of our products liability attorneys will contact you.
If you know of someone with a Medtronic implantable infusion pain pump have them log onto our site at painpumpfailure.com and they can submit their questions to us.
