The Medtronic SynchroMed II drug infusion pump has been linked to reports of accidental overdose, underdose, life-threatening withdrawals and death.
Free Confidential Lawsuit Evaluation: If you or a loved one was injured by a Medtronic pain pump, you should contact our law firm immediately. You may be entitled to compensation by filing a suit against the manufacturer and our lawyers can help.
What is the Medtronic Pain Pump?
Medtronic Inc. has developed 2 implantable infusion pumps, the SynchroMed II and SynchroMed EL, which was discontinued. The pumps are implanted in patients’ lower abdomens underneath the skin, with one end of a catheter inserted into the intrathecal space in the spine and the other end connected to the device.
The pumps inject pain medication into recipients’ spines at a preprogrammed rate or time. Both the SynchroMed II and SynchroMed EL were approved by the U.S. Food & Drug Administration (FDA) for injecting morphine, ziconotide, Lioresal (baclofen), floxuridine and methotrexate. Over 200,000 SynchroMed pumps have been implanted worldwide, according to Medtronic.
Infusion Pump Recalls
Medtronic has issued numerous recalls for its SynchroMed Pain Pumps. Among them:
- August 2007 – FDA issues Class I Recall for the Medtronic SynchroMed El Implantable Infusion Pump. The devices were found to stall at an unacceptably high rate, putting recipients at risk of serious injury or even death.
- February 2011 – Recall issued for the Medtronic SynchroMed II Infusion Pump due to a design flaw that could potentially lead to “pocket fills” during device refills.
- July 2011 – FDA issues a Class I Recall for SynchroMed II Infusion Pumps due to battery problems that may cause the device to fail.
- June 2013 – Third recall issued for the SynchroMed II after the device was linked to at least 14 patient deaths and numerous design flaws.
The most commonly reported complication associated with the infusion pump was accidental injection of the pain medication directly into the patient’s tissue instead of the pump. That complication was attributed to 11 deaths. Two patients died due to pump blockage and another died from an electrical short, according to Medtronic.
Patients can visit the Medtronic device identification webpage and enter their pump’s serial number to see if it has been affected by any of these recalls.
Pain Pump Complications
- Lack of therapeutic effectiveness
- Device malfunction
- Pump blockage
- Electrical short
- Respiratory depression
If you have been implanted with a Medtronic Pain Pump, FDA recommends that you carry your patient identification card with you at all times and contact your doctor immediately if the device’s alarm goes off or if you begin to suffer a return of symptoms that the pump is supposed to treat. The pumps are designed to have an 84 month lifespan, but the premature failures have been reported to occur as early as 48 months, Medtronic has warned.
Do I Have a Medtronic SynchroMed Infusion Pump Lawsuit?
The Medical Device Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Medtronic Infusion Pump lawsuits. We are handling individual litigation nationwide and currently accepting new injury and death cases in all 50 states.
Free Confidential Case Evaluation: Again, if you or a loved one was injured by the Medtronic SynchroMed II Infusion Pump, you should contact our law firm immediately. You may be entitled to a settlement by filing a suit and our lawyers can help.