A potentially dangerous software problem has forced Medtronic, Inc. to announce a recall for certain SynchroMed II and SynchroMed EL Implantable Infusion Pain Pumps. The U.S. Food & Drug Administration (FDA) has designated the action a Class I recall, which indicates that use of the affected infusion pumps may result in serious injury or death.
SynchroMed implantable infusion pumps are indicated to treat primary or metastatic cancer, chronic pain and severe spasticity. They are programed to deliver medications to a specific site inside a patient’s body.
According to an FDA alert dated March 14th, the software issue the recalled infusion pumps could cause unintended delivery of drugs during a procedure called priming bolus, which is used to deliver a large dose of medication to a patient’s spine. The problem may result in an overdose or underdose of the drug, leading to serious adverse events such as respiratory depression, coma or death.
Medtronic informed its customers of the software problem via an Urgent Medical Device Correction notice issued in September 2016.
“On October 7, 2016 Medtronic initiated an update recall to communications issued on May 14, 2013,” the FDA recall notice stated. “Medtronic made a software change to the Synchromed II application contained on the Model 8870 software application card. This change will correct the priming volume associated with the priming bolus function. They also updated the labeling related to the software change and priming bolus function.”
The recall includes 14,499 Model 8870 software application cards distributed in the U.S. from September, 2013 until October 3, 2016. SynchroMed II and SynchroMed EL devices affected by this action include those bearing Product Code LKK and Model Numbers: 8637-20, 8637-40, 8626-10, 8626L-10, 8626-18, 8626L-18, 8627-10, 8627L-10, 8627-18, 8627L-18.
Medtronic representatives began visiting affected customers on October 3, 2016, to replace software application cards with the updated version. The company has advised its customers to continue using the current software card and its displayed tubing volume until a representative is able to make the exchange.
Adverse events or side effects related to the use of the SynchroMed implantable infusion pumps should be reported to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program at www.fda.gov/MedWatch/report.