Medtronic SynchroMed infusion pumps are associated with at least 14 deaths and hundreds of serious injuries. The pumps have been recalled numerous times and they are no longer available for sale.
UPDATE: Judge Allows Synchromed II Pump Lawsuit to Proceed
In March 2021, a judge in West Virginia allowed a pain pump lawsuit to proceed from a 70-year-old man who was injured by a Medtronic Syndromed II Infusion Pump. The lawsuit was filed by John David B., a man who claims that his pump’s motor stalled and stopped delivering pain medicine.
Medtronic Sets Up $35 Million Compensation Fund for Defective Pumps
Medtronic has been plagued by so many problems with the SynchroMed II pump that the company set up a $35 million settlement in 2019 to compensate people who were injured by it.
What is the Problem?
Medtronic Syndromed pain pumps are medical implants that treat severe chronic pain. Unfortunately, in July 2009, Medtronic reported that many pumps were failing due to the formation of a filmy substance in the pump battery that can cause the pump to suddenly shut down and stop delivering pain medicine.
What is the Syncromed Pump?
Medtronic manufactures the SynchroMed EL and SynchroMed II infusion pumps for pain management. The devices are implanted in the body to deliver a continuous flow of medications. They have been implanted in over 230,000 patients in the last 25 years.
SynchroMed Pumps Linked to 14 Deaths
In 2013, Medtronic issued 4 separate Class I recalls for safety defects and said 14 deaths were associated with the SynchroMed pump. In most cases, patients died from overdoses or went into withdrawal after not receiving enough medication.
Medtronic Agrees to Stop Selling SynchroMed Pumps
In April 2015, Medtronic entered into a consent decree with the FDA and the Justice Department. Medtronic agreed to stop manufacturing and selling the SynchroMed II pump except in extraordinary cases.
SynchroMed Overdose Injuries and Deaths
In January 2011, SynchroMed pumps were recalled because doctors could accidentally inject overdoses of painkillers when trying to refill the pump. In July 2012, FDA issued a warning after receiving 270 reports of serious injuries and 8 deaths associated with accidental overdoses. Medtronic was accused of failing to fix the problem after receiving complaints in 2007.
Battery Issues and Electrical Short-Circuiting
The SynchroMed II was recalled in 2009 and again in 2011 for battery problems that could interrupt infusion of medicines. In June 2013, the SynchroMed EL and II were recalled for electrical short-circuiting and other safety issues.
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