Drug delivery problems with Medtronic SynchroMed infusion pumps could cause severe injury or death, federal regulators warn.
On Tuesday, the FDA announced that it was giving a Class I designation to a warning issued by the manufacturer last year, over a software problem that may cause unintended drug delivery during a priming bolus procedure.
“During this procedure, patients may receive the drug unintentionally at a high rate of infusion in the cerebrospinal fluid followed by a period of reduced drug delivery after the priming bolus,” the FDA warns. “This can result in a drug overdose or under dose which can lead to serious adverse health consequences such as respiratory depression, coma or death.”
The FDA determined that the prior action taken by the manufacturer constitutes a SynchroMed II and SynchroMed EL recall, giving it the most serious classification for a medical device recall.
Medtronic originally issued an Urgent Medical Device Communication in September 2016, which notified affected customers of a software change, labeling changes on Model 8870 software card recommendations, and new recommendations for priming bolus procedures.
A month later, Medtronic updated a recall issued in May 2013, announcing a software change for the Synchromed II application on the Model 8870 software application card, as well as additional label changes.
In November, Medtronic announced that SynchroMed II problems had led to at least two deaths, and more than 100 adverse events from over delivery of medications, known as overinfusions. Medtronic refused to issue a SynchroMed recall at that time.
The recall affects about 14,499 SynchroMed II Implantable Drug Infusion Pumps and SynchroMed EL Implantable Drug Infusion Pumps with product code LKK, and model numbers 8637-20, 8637-40, 8626-10, 8626L-10, 8626-18, 8626L-18, 8627-10, 8627L-10, 8627-18, and 8627L-18. The units were manufactured and distributed from September 2013 to October 2016.
A History of Medtronic SynchroMed II Problems
The Medtronic SynchroMed II Infusion Pump line has been plagued with problems over the last several of years, which have caused many users to suffer severe and often life-threatening health issues.
In February 2011, the FDA declared a Class I Medtronic Synchromed pump recall following reports that doctors were accidentally injecting drugs directly into patients’ subcutaneous tissues while attempting to refill the devices. These “pocket fills” resulted in at least eight deaths and 270 injuries requiring medical intervention.
In September 2011, a Synchromed II battery recall was announced after the company received reports of batteries becoming covered with a thin film and failing. The FDA classified that as a Class I recall as well. Class I medical device recall classifications mean that the FDA believes the device has a reasonable likelihood of causing severe injury or death.
In July 2012, the FDA sent a warning letter to Medtronic over the infusion pumps, ordering the company to put in place a plan to deal with reported failure problems. The FDA had received 567 complaints about motor corrosion in the SynchroMed II pump between then and October 2007. The corrosion caused gears to lose teeth, which lead to the motor seizing up.
The FDA finally entered into a consent decree with Medtronic over the repeated errors and manufacturing problems in April 2015, which required the company to cease manufacturing, designing and distribution of new Medtronic Syncromed II infusion pumps, except in cases where a doctor determined it was medically necessary for a patient’s treatment.
In September 2016, a Pennsylvania man filed a Medtronic Synchromed II lawsuit over an overinfusion incident that left him hospitalized after the device allegedly overdosed him on pain medications delivered to his spine.