Problems with the SynchroMed II have been linked to at least 16 patient deaths (including the recent cases) since 1996, according to Bloomberg. The most common complication was the accidental injection of pain medication into the patient’s subcutaneous tissue, which caused 11 deaths. Two patients died from a blockage and another from an electrical short.
On Tuesday, the U.K.’s Medicines and Healthcare Products Regulatory Agency (MHRA) published an update from Medtronic regarding the problem of “overinfusion,” which occurs when the pump releases more pain medication than intended. The agency said that two patients died and 103 SynchroMed II infusion pumps were affected by problems that led to overinfusion through July 5, 2016.
“Medtronic has been unable to establish a definitive causal relationship between the adverse events and overinfusion, due to potential contributing factors,” MHRA said. “However, it is reasonable to conclude that overinfusion was a contributing factor.”
Other contributing factors may include dosage of the infused medication, patients’ medical history, and simultaneous use of other drugs, according to Medtronic. Of the 103 pain pumps linked to adverse events, 99 of the devices contained “non-indicated” drug formulations the last time they were filled.
Medtronic recommends using only approved medications in the infusion pumps, and to monitor patients for symptoms of overdose or withdrawal during appointments. Drug withdrawal can be a problem because overinfusion can empty the pump’s reservoir without setting off the device alarm, causing the medication to unexpectedly stop being released.
Last year, FDA filed a consent decree against Medtronic for repeated failures to correct manufacturing problems with the SynchroMed II. The company has repeatedly counseled doctors on the best ways to use the pumps and avoid problems.
Source: Minneapolis Star Tribune