Medtronic...Beleaguered Consumers and Yet Another Recall
Brenda FulmerSeptember 29, 2009 3:31 PM
(866) 735-1102 Ext 703
On August 27, 2009, the Food & Drug Administration issued yet another recall for a device manufactured by Minnesota-based Medtronic (who also has experienced recalls of its pain medication infusion pumps, defibrillators, defibrillator leads, and insulin pumps recently). This Class I recall, the most serious level of recall of an FDA-approved medical device, involved the Medtronic Neuromodulation, INDURA 1P Intrathecal Catheter, Sutureless Pump Connector Revision Kit, and Intrathecal Catheter Pump Segment Revision Kit. These devices are used in connection with the popular Medtronic SynchroMed II and SynchroMed EL infusion pumps; these pumps deliver pain medications such as baclofen and other drugs directly into the spine. Chronic pain patients have been led to believe that implanted pain pumps such as the Medtronic devices would provide a panacea and avoid all of the pitfalls of chronic use of narcotic pain medication, including the stigma and potential addiction associated with such drugs, their side effects, and recent safety concerns (including manufacturing defects in Fentanyl pain patches that leach toxic levels of the drug due to improper sealing techniques and Ethex morphine pills manufactured at double strength).
The latest recall for Medtronic and its pain pump line stems from design defects that prevent the catheter from properly connecting to the infusion pump, which could lead to disconnection of the pump or a blockage. The inability of the device to properly administer a steady stream of pain medications to a patient creates the potential for an inadvertent overdose or unnecessary suffering for the patient who receives an inadequate level of pain medication. The SynchroMed II line of infusion pumps has been in the news a great deal over the past couple of years with numerous advisories of potential safety problems. These are located on the Medtronic site and can be accessed by clicking on "Medical Device Safety Alerts". They include:
- July 2009 -- Premature Battery Removal
- August 2008 -- Potential Effects of MRI Imaging on Pump Performance
- June 2008 -- Potential Disconnection of Sutureless Connector Catheters
- May 2008 -- Pump Malfunction Due to Missing Propellant
- January 2008 -- Formation of Inflammatory Mass at Catheter Tip Leading to Serious Injuries
- August 2007 --Notification of Malfunction of Synchromed El Pump with Stalling Due to Gear Shaft Wear
- November 2006 -- Educational Brief to Physicians on proper monitoring of patients to reduce risk of death or serious injury during initiation of intrathecal opioid therapy for pain
- July 2006 -- Voluntary Worldwide Medical Device Recall for Model 8731 Intrathecal Catheter and Model 8958 Intrathecal Catheter Distal Revision Kit (due to platinum-iridium tip becoming dislodged by guide wire during implantation)
- May 2006 -- Medical Device Recall of Model 8627 SynchroMed EL Due to Pump Reliability Concerns
- January 2006 -- Education Brief for Patients regarding drug formulations using preservatives that may be neurotoxic or compromise the safe use of the Medtronic infusion pumps
Patients who have received these devices should contact their physician for more information regarding the impact of these various recalls on the functioning and safety of their implanted infusion pumps. Medtronic has a sales force that regularly calls upon physicians and should be able to provide current safety data to healthcare providers and their patients. There are also tools available on Medtronic’s web site that enable physicians and patients to input the serial number for a particular infusion pump device to determine whether it is impacted by the various safety alerts and recalls.
It appears from the documents published on Medtronic’s web site that it has also enhanced its warranty coverage to include some of the out of pocket expenses incurred by patients. A review of these warranty supplements, however, indicates that patients are only being reimbursed up to $1,000 for out of pocket expenses associated with surgery and medical care necessitated by the defective product and that health insurers are left without recourse for the tens of thousands of dollars that they might be required to pay for medical care necessitated by the litany of defects associated with these pain pumps. This is an excellent example as to why federal preemption for FDA-approved medical devices (as outlined in the Medtronic v. Riegel decision) is a travesty for patients, physicians, and health insurers, all of whom are shouldering the burdens created by poorly designed and manufactured medical devices. It is for this reason that the Medical Device Safety Act, which would once again hold device manufacturers such as Medtronic responsible for their defective products, is gaining significant, bi-partisan support in Congress. More information about federal preemption and how it unfairly shields manufacturers of defective products can be found on our firm’s web site. We urge you to contact members of Congress to voice your support for this very important safety legislation.