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You should Contact a Qualified Pain Pump Lawyer

The FDA has issued another recall for a device manufactured by Medtronic on August 27, 2009.  Medtronic has already experienced recalls of its pain medication infusion pumps, defibrillators, defibrillator leads and insulin pumps recently.  This newest recall is a Class 1 Recall which is the most serious level of recall of an FDA approved medical device.  This recall includes the Medtronic Neuromodulation, INDURA 1P Intrathecal Catheter, Sutureless Pump Connector Revision Kit and the Intrathecal Catheter Pump Segment Revision Kit.  These devices are used in connection with the Medtronic SynchroMed II and SynchroMed EL infusion pumps.  These pumps deliver pain meds such as baclofen and other drugs directly into the spine.  If you have the above Medtronic components, you should contact a Pain Pump Lawyer to become informed about your legal rights and see if you qualify for a pain pump lawsuit.  A Pain Pump Lawyer can best evaluate your particular situation.

This latest recall for Medtronic stems from design flaws that prevent the catheter from properly connecting to the infusion pump.  This can lead to disconnection of the pump or blockage.  The inability of the pump to administer a steady stream of pain medication to a patient creates the potential for an under or overdose of medication.

FDA Issisues Pain Pump Warning

 A Medtronic Pain Pump Warning for its SynchroMed II line of infusion pumps has been in the news over the past few years.  If you need legal assistance, it is best to contact a Pain Pump lawyer.  A Pain Pump Lawyer is well informed on various warnings and recalls.  The Medtronic Pain Pump Warning can be seen on the FDA website under Medical Device Safety Alerts.  These safety alerts 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 injury
  • 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 any of these implants should contact their healthcare provider for more information about the impact of these recalls in terms of functionality and safety of their pain pumps.  You can also contact a Pain Pump Lawyer to find out what your legal rights are.  The Medtronic website provides support for doctors and patients allowing you to input the serial number for a particular pump to determine whether it is affected by the various safety alerts and recalls.  The Medtronic website has also enhanced its warranty coverage to include some of the out of pocket expenses incurred by patients up to $1000.  Unfortunately, health insurers and consumers are left without recourse for the tens of thousands of dollars that they might be required to pay for medical care necessitated by the long list of defects associated with these pain pumps.

If you have a Medtronic SynchroMed, SynchroMed II, IsoMed or intrathecal implantable infusion pain pump implanted into your body, you need to speak with a Pain Pump Lawyer to determine if your pain pump was the subject of a recall and what your options may be.  A Pain Pump Lawyer can help evaluate whether you may be entitled to compensation from Medtronic.

You May be entitled to Compensation, so act now.

If you or a loved one has been injured as a result of a Medtronic Pain Pump, contact us now to speak with our qualified professionals about possible compensation.  Call us now at 877-222-7069 or use the contact form for a free case review.

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