The FDA today updated Medtronic’s Class I recall for the company’s SynchroMed II and SynchroMed EL implantable drug pumps, which were designed to locally treat primary or metastatic cancer, chronic pain, and severe spasticity.
The pumps were recalled in 2013 because they unintentionally delivered drugs during the priming bolus procedure and patients were at risk for overinfusion in the cerebrospinal fluid followed by a period of reduced drug delivery.
In October last year, Medtronic said that the SynchroMed II implantable drug pump was linked to more than 100 adverse events including 2 previously unreported deaths. The Fridley, Minn.-based company eventually agreed to halt the manufacture of the SynchroMed II pump after years of problems with the device.
As of July 5, 2016, there were 103 incidents of overinfusion among the more than 238,000 SynchroMed II pumps implanted since the device came to market.
“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 in these cases,” the company said in a letter. “While the full drug history of these pumps is unknown, 99 of the 103 pumps were associated with non-indicated drug formulations in use at the time of the pump’s last refill.”
The updated Class I recall affects SynchroMed II and SynchroMed EL implantable drug infusion pumps manufactured from Sept. 2013 to Oct. 2016 and includes 14,499 Model 8870 software application cards.
The company’s updated communications said that Medtronic made a software change to the SychroMed II application on the Model 8870 software application card.
“The change will correct the priming volume associated with the priming bolus function,” the update said.
Representatives from Medtronic began visiting customers in October last year to replace software application cards with the updated version, according to the updated communication.