Medtronic SynchroMed Implantable Infusion Pump Corrective Action Labeled as Class I. Medtronic’s SynchroMed Implantable Infusion Pumps are subject to corrective action due to a software issue that can cause drugs to be delivered to patients unintentionally. The action affects the SynchroMed II and SynchroMed EL Implantable Drug Infusion Pumps, devices that deliver drugs such as pain medications to a specific area in the patient’s body. In response to the issue, Medtronic is updating its software. The U.S. Food and Drug Administration (FDA) has labeled the action as a Class I recall.
Parker Waichman LLP has decades of experience representing clients in medical device injury lawsuits and other product liability lawsuits. The firm continues to offer free legal consultations to individuals with questions about filing a Medtronic SynchroMed II Infusion Pump lawsuit.
Fierce Biotech reports that a “recall” may not necessarily mean that a product is being pulled from the market; it can also indicate a corrective action. The latter applies in this situation. Class I recalls are the highest-priority actions, the FDA uses a Class I label to indicate that the affected device could lead to serious injury or death.
According to a Mar. 14, 2017 safety alert posted on the FDA website, the infusion pumps are subject to corrective action “because a software problem may cause unintended delivery of drugs during a priming bolus procedure, used to quickly deliver large dose of medication from the device to the patient’s spine.”
“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. 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.”
Medtronic notified customers of the software issue in September 2016. The company issued an Urgent Medical Device Correction notice describing the software update, labeling changes, software recommendations, and new priming bolus recommendations.
SynchroMed Infusion Pump Background and Dosing Errors
Parker Waichman notes a history of safety concerns associated with the SynchroMed Infusion Pump, which is used to treat patients with metastatic cancer, chronic pain, and severe spasticity. The FDA approved the SynchroMed II Implantable Infusion Pump systems in 2004.
Regulators identified potential problems with the infusion pumps starting in 2006. Between 2006 and 2013, the agency inspected Medtronic Neuromodulation five times and issued three warning letters. The FDA said, “violations included inadequate processes for identifying, investigating, and correcting quality problems with the SynchroMed II Implantable Infusion Pump Systems; failure to document design changes; and failure to ensure that finished products meet design specifications.”
In 2012, a lawsuit was filed against Medtronic over the SynchroMed infusion pump. The plaintiff is a man who became paralyzed, allegedly due to the pump’s manufacturing defects. He alleges that his injuries occurred because Medtronic failed to notify the FDA about manufacturing defects in a timely manner.
Medtronic issued three separate recalls for the SynchroMed in 2013. The infusion pump was recalled due to unintended drug delivery during the priming bolus procedure, electrical issues that could interfere with therapy, and replacement of the catheter connector.
“In 2013, Medtronic notified customers that the unintended delivery of drug during the priming bolus can contribute to patient overdose or underdose symptoms which may be clinically relevant,” Medtronic said, according to Fierce Biotech. “The 2016 notification was intended to inform physicians that Medtronic is updating the Model 8870 software application card, as well as the SynchroMed® Infusion System labeling to address the issue.”
Due to repeated violations, the FDA filed a consent decree against Medtronic in 2015. The agency ordered Medtronic to stop manufacturing and distributing the products. Regulators made an exception for cases where physicians believe the device was medically necessary.
The consent decree was filed against two Medtronic officers who repeatedly failed to address violations, according to the FDA. A total of 14 deaths were linked to the series of SynchroMed Infusion Pump recalls. Among those fatalities, 11 were associated with pain drugs being injected into the tissue near the pump as oppose to the pump itself. Two deaths were linked to misalignment of the drug-delivery tube and the pump’s connection site. One fatality may have been caused by an electrical short; that patient died due to loss of therapy.
UK Regulators Warn of 2 More Patient Deaths Associated with Medtronic Infusion Pumps
SynchroMed Infusion Pump issues have not been limited to the United States. In October 2016, the U.K’s Medicines & Healthcare Products Regulatory Agency published a letter from Medtronic to healthcare professionals notifying them of overinfusion. The company had previously communicated on the issue in March 2014; this letter was an update.
Medtronic said it knew of five reports of overinfusion as of January 2016. These reports are based on data from the company’s long-term multi-center registry study. Medtronic said these cases all involved situations where the pumps were being used in an “off-label” or unapproved, manner.
“Medtronic has been unable to establish a definitive causal relationship between the adverse events and overinfusion, due to potential contributing factors. However, it is reasonable to conclude that overinfusion was a contributing factor,” the company said in its letter to health care professionals.
The company said 103 pumps were associated with adverse event reports as of Jul. 5, 2016. The severity of injuries varied between patients, with some reporting temporary discomfort and others reporting life-threatening dosing errors. The devices were linked to two additional deaths since the last update, Medtronic said. Out of the 103 pumps implicated, 99 were reportedly used with unapproved drugs at the time of last refill.