Medtronic Synchromed Pain Pump Failure Lawsuits. According to Medtronic’s news report in late 2016, their SynchroMed II implantable drug pump was linked to more than 100 adverse events including 2 previously unreported deaths.
In an October 2016 letter to doctors by the U.K.’s Medicines & Healthcare Products Regulatory Agency, Medtronic said the SynchroMed II pump can deliver too much medicine but that the exact cause of the over infusions isn’t clear.
Medtronic Synchromed Pain Pump beset by failures
In 2015 Medtronic signed a consent decree with the FDA after years of problems with the device, agreeing to stop the manufacture of SynchroMed II after repeatedly failing to correct violations found by the FDA over a 7-year period.
In the October letter, Medtronic said a post-market registry trial showed 5 incidents of over infusions among 7,505 implanted SynchroMed II pumps. Medtronic admitted that “All 5 occurrences of over infusions noted in the Registry were associated with pumps used to infuse drug formulations that are not indicated for use with the SynchroMed II pump.”
But as of July 2016, there were 103 cases of over infusions among the more than 238,000 SynchroMed II pumps implanted since the device hit the market, linked to life-threatening overdose and/or withdrawal, and the 2 deaths, according to the letter.
Medtronic Synchromed Pain Pump failure concerns
Last year’s consent decree with the FDA came after regulators in jurisdictions including the U.S., the U.K. and Hong Kong issued a series of warnings about the SynchroMed device. Some 14 deaths were linked to the device at that time.
Recently Medtronic sent out a “Dear Healthcare professional” letter, updating a SynchroMed II infusion pump recall originally issued in 2011. Medtronic has a product lookup site to check if the battery pack is at risk of failure.
Back in 2011, the Medtronic Synchromed II pumps were recalled because a film could develop on the batteries, causing the pump device to fail. There were over 55 battery failure problems at the time of the recall, and the defect caused at least one patient death.
Medtronic found that the highest risk of failure was in their Model 8637 pumps made in January 2011 through June 2011. Because of battery failure, the Model 8637 pumps devices have been linked to a 3.17% cumulative probability of pump failure at 72 months after implant.
What is the SynchroMed II Pump?
The Medtronic SynchroMed II infusion pump, known as a pain pump, is a medical device that is implanted surgically. The Medtronic SynchroMed II infusion pump uses a plastic tube or catheter to deliver pain medication near the patient’s spinal cord.
The battery powered Medtronic SynchroMed II infusion pump is implanted under the skin. The pump is used to treat patients with primary or metastatic cancer, severe muscle spasms, chronic pain, and other severe painful 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.
In September 2016, Jason Silver from Pennsylvania filed a Medtronic Synchromed II lawsuit over an over-infusion incident that left him injured after the pump device allegedly overdosed him on pain medications delivered to his spine.
Free Confidential Lawsuit Evaluation: If you or a loved one was injured or died as result of a Medtronic pain pump malfunction, you should contact Dr. Shezad Malik law firm immediately at 214-390-3189. You may be entitled to compensation by filing a suit against the Medtronic and our lawyers can help.