On March 14, 2017, Medtronic recalled the SynchroMed Implantable Infusion Pump 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 a priming bolus 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.
The SynchroMed II and SynchroMed EL Implantable Drug Infusion Pumps (SynchroMed Implantable Infusion Pumps) are programed to deliver prescribed drugs to a specific site inside the patient’s body. The SynchroMed pumps are used to treat primary or metastatic cancer, chronic pain, and severe spasticity.
The FDA has classified this recall as a Class I recall, which is the most serious type of recall. Class I recalls involve situations in which there is a reasonable probability that use of the product will cause serious adverse health consequences or death.
See the FDA Safety Alert
See the Recall
See also Medical Law Perspectives, June 2014 Report: Physician and Manufacturer Risks for Pain Pump Injuries: Malpractice, Negligence, and Products Liability
See also Medical Law Perspectives, May 2015 Report: Chemotherapy: Risks and Liabilities When the Treatment Is Toxic
See also Medical Law Perspectives, January 2014 Report: Prescription Painkillers: Risks for Patients, Pharmacists, and Physicians
See the Medical Law Perspectives February 10, 2015, Blog: Infusion Pump Failures: Product Liability and Human Error