DEPARTMENT OF JUSTICE AND FDA TAKE ACTION AGAINST MEDTRONIC:
In 2006, 2007, 2011, 2012 and 2013 the FDA inspected Medtronic SynchroMed manufacturing facilities each time finding numerous violations of FDA regulations. Warning letters were issued after each inspection. Based upon Medtronic’s failure to appropriately address these violations, the FDA deemed the devices to be ‘adulterated’ because they were not manufactured according to the standards required by law.
On April 27, 2015:
The U.S. Department of Justice filed an injunction against Medtronic in U.S. District Court demanding that Medtronic stop all manufacturing and distribution of the SynchroMed II Infusion System. This injunction followed years of failed attempts by the FDA to force Medtronic to follow those FDA regulations that govern how medical devices are manufactured, packaged and distributed. A copy of the Injunction can be found by clicking here.
Medtronic entered into a Consent Decree with the DOJ and FDA in which Medtronic agreed to not manufacture or distribute any new SynchroMed II devices except under extraordinary circumstances, including where a treating physician certifies that a SynchroMed pump is medically necessary and that the benefits of having this particular pump outweigh the risks. A copy of the Consent Decree can be found by clicking here. The Consent Decree received judicial approval on April 29, 2015. The Consent Decree requires Medtronic to undertake extensive corrective measures to be reviewed and approved by the FDA before normal operations can recommence.
PERSONAL INJURY AND PRODUCT LIABILITY ALLEGATIONS AGAINST MEDTRONIC:
IS THIS DEVICE AND WHY IS IT USED?
The Medtronic Synchromed II is a programmable infusion system implanted in the abdomen to deliver medications to treat chronic pain, severe spasticity, and cancer. The system consists of a battery-powered pump and catheter. The medication reservoir is filled by a clinician on average 3 to 4 times a year. The device is manufactured by Medtronic Neuromodulation and has been available since 2004.
The Medtronic Synchromed II System has been approved by the FDA to deliver the following medications:
WHAT HAPPENS WHEN THE DEVICE FAILS?
SYMPTOMS OF THESE INJURIES:
Symptoms that the device is not working properly include:
Appearance of an overdose of the medication.
Sudden worsening symptoms of the condition which the medication delivered by the pump was intended to treat.
Some of the symptoms seen include:
Loss of consciousness
Baclofen withdrawal syndrome is potentially life-threatening. Symptoms include: fever, hallucinations, rebound spasticity, autonomic instability, mental status changes, seizure, and rhabdomyolysis.
WHAT TO DO IF YOU HAVE BEEN AFFECTED BY A FAULTY MEDTRONIC SYNCROMED II INFUSION PUMP:
If you or a loved one received a Medtronic SynchroMed II Infusion Pump implant, and suffered one of the injuries listed above, contact us immediately to receive a free confidential consultation to discuss your legal rights. You may be entitled to compensation. Contact us today!
Accepting Cases Nationwide
Receive a free confidential consultation
* Indicates a required field
Complete and submit this form and an attorney will contact you.
Toll Free: 800-672-6508
Accepting Medtronic SynchroMed Pain Pump injury cases nationwide. Call today to speak with an attorney about your legal rights.
CYNTHIA K. GARRETT
Attorney at Law
CONTACT US TODAY
406 S. Boulder Avenue, Suite 400
Tulsa, OK 74103-3800
P.O. Box 1550
Jenks, OK 74037-1550
Toll Free: 866-584-0070