The Medtronic SynchroMed II drug infusion pump has been linked to reports of accidental overdose, underdose, life-threatening withdrawals and at least 14 patient deaths.
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 SynchroMed II Pump?
The Medtronic SynchroMed II infusion pump, commonly known as a pain pump, is a surgically implanted device that uses a catheter to deliver pain medication directly into an area near the patient’s spinal cord. Inserted just under the skin, the pump is used to treat patients with primary or metastatic cancer, severe muscle spasms, chronic pain, and other serious health conditions. The SynchroMed II was approved by the U.S. Food & Drug Administration (FDA) in 2004, and there are currently about 270,000 of the pumps on the market.
Pump Pump Recall Timeline
Since the first Synchromed Implantable Infusion Pump System was approved in 2004, numerous problems have been attributed to the devices, and more than 30 Class I Recalls have been issued:
- 2006 – Problems linked to the manufacture of Medtronic Pain Pumps, resulting in over- or under-infusion, or a delay in therapy for patients.
- August 2007 – Class I Recall issued for the Medtronic SynchroMed El Implantable Infusion Pump. The devices, which are part of the SynchroMed EL Infusion System, were found to stall at an unusually high rate, putting patients at risk of serious injury or even death. The recall included models 8626-10, 8626L-10, 8626-18, 8626L-18, 8627-10, 8627L-10, 8627-18, and 8627L-18. Only these models with motors manufactured before September 1999 were affected by the recall.
- January 2009 – Medtronic sent a letter to physicians warning about potential battery problems with the SynchroMed II. Battery power problems may lead to device failure and the release of too much or too little pain medication.
- January 2011 – Medtronic sends a letter warning healthcare professionals regarding a design flaw that could potentially lead to “pocket fills” during device refills.
- February 2011 – Class I Recall issued for the Medtronic SynchroMed II Infusion Pump due to the “pocket fill” design flaw.
- July 2011 – FDA issues a Class I Recall for SynchroMed II Infusion Pumps due to battery issues originally warned against in 2009.
- July 17, 2012 – FDA sent a warning letter to Medtronic citing the company for failing to correct problems with the SynchroMed Pain Pump, including reports of the devices stalling due to motor corrosion and failing to deliver medication. According to the FDA, “corrosion[ … ] can result in partial or complete removal of gear teeth.” This can ‘seize’ the motor altogether or gear wheel [ … ]will continue to rotate, but there may be no drug delivery in the region of missing teeth.”
- 2013 – Medtronic notified physicians of 4 potential flaws with the SynchroMed Infusion Pump. All 4 defects were classified by the FDA as Class 1 recalls, meaning they can lead to serious injury or death.
At least 14 deaths have been linked to Medtronic Infusion Pumps. Most took place when patients were either deprived of pain medication and entered withdrawal, or after drug overdoses. A blockage that stopped the drug’s flow led to 2 deaths, and an electrical short caused one death, according to WSJ. Medtronic said 11 of the deaths occurred between 1996 and April 2013.
Despite these problems, the company does not recommend that patients already implanted with the infusion pumps have them removed. They should, however, contact a doctor right away if they notice a change or return of symptoms, or hear an alarm which signals that the pump motor has stalled.
Click here for a complete list of Medtronic SynchroMed Infusion Pump recalls.
Pain Pump Complications
- Lack of therapeutic effectiveness
- Device malfunction
- Pump blockage
- Electrical short
- Respiratory depression
FDA Announces Consent Decree with Medtronic Over Problems with SynchroMed Pump
On April 27, 2015, federal authorities reached a proposed consent agreement with Medtronic for failing to correct violations with its SynchroMed Pump, according to the Wall Street Journal. The U.S. Justice Department, working with the FDA, filed the decree along with a complaint alleging that Medtronic and 2 of its executives — Chairman and Chief Executive S. Omar Ishrak and Senior Vice President Thomas M. Tefft — distributed ‘adulterated’ medical devices.
According to the complaint, the infusion pumps weren’t produced in accordance with current manufacturing standards. As part of the proposed decree, Medtronic has agreed to stop manufacturing and distributing the SynchroMed II pump except in rare cases, such as when a doctor certifies that the device is medically necessary. The company won’t be allowed to resume openly distributing the SynchroMed II until it gets permission from the FDA.
Authorities contend that Medtronic repeatedly failed to correct violations of FDA quality standards. Between 2006 and 2013, FDA investigators conducted 5 inspections of Medtronic’s Neuromodulation facilities in Columbia Heights, Minnesota. The inspections uncovered ‘significant violations,’ including those related to complaint handling, corrective and preventive actions. Such measures are intended to ensure that a pump malfunction leading to significant injury or death gets investigated, and that changes are made as a result.
FDA inspectors “repeatedly observed and documented violations” of federal quality regulations, according to the decree. “Defendants promised corrections at the conclusion of each inspection.” However, “none of these responses contained adequate evidence that Defendants [Medtronic and its officials] have corrected their deviations.”
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.