Medtronic is updating the software for its SynchroMed implantable infusion pumps due to a software issue that could cause the devices to deliver too much or too little of a drug. The action is deemed a class 1 recall by the FDA.
The recall, or corrective action, affects the SynchroMed EL and SynchroMed II pumps, which are programmed by a clinician to deliver prescribed drugs to specific parts of the body. A recall refers to a company's corrective action or removal of a marketed product—it does not require market withdrawal. The SynchroMed pumps remain on the market.
"Intrathecal drug delivery is an important treatment option for patients with chronic, intractable pain or severe spasticity who have not had success with other treatment options or who experience intolerable side effects with oral medications," said a Medtronic spokesman. "The SynchroMed II Implantable Infusion System continues to demonstrate strong overall reliability, and Medtronic is confident in its ability to deliver safe and effective therapy."
Part of the SynchroMed II system, the pump stores and delivers pain medication via a catheter implanted under the skin. The software problem could cause an unintentional dose of drugs during a priminig bolus procedure, which is used to quickly send a large dose to the patient’s spine, according to the FDA.
An over- or underdose of medication could lead to respiratory depression—a dangerously slow breathing rate—coma, or death, the FDA said.
Medtronic issued an Urgent Medical Device Correction notice back in September. It described a software update and changes in labeling and made new priming bolus recommendations. Medtronic representatives started visiting customers to replace software cards with updated cards, which "mitigates the potential for clinically relevant effects of over-delivery of unintended drug during the full system priming bolus procedure," a Medtronic spokeman said.
A patient sued Medtronic in 2012, charging that a defective SynchroMed pump left him paralyzed. The plaintiff claimed that if the devicemaker had immediately reported manufacturing issues to the FDA, doctors and patients could have avoided the device and his injury wouldn’t have happened.
In 2013, Medtronic issued three separate notifications recalling the SynchroMed pumps. The reasons for recall were unintended delivery of drugs during the priming bolus procedure, potential electrical shorting in the pump that could interrupt therapy, and the replacement of the catheter connector, which could interrupt treatment by blocking drug flow.
"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. "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. "
And in 2015, the FDA filed a consent decree against Medtronic for “repeatedly failing to correct violations” related to the SynchroMed II system. The decree ordered the company to stop manufacturing and distributing the devices, except in cases where a doctor deemed the device medically necessary in a patient’s treatment.
The consent decree did not affect patients already using the device and did not require the company to retrieve distributed pumps, Medtronic said at the time.
Editor's note: This story has been updated to include comments from Medtronic, as well as to clarify the nature of the recall (Medtronic's 2016 notification announces a software update).