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ISSUE: Medtronic is recalling the SynchroMed Implantable Infusion Pumps 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 this 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.
BACKGROUND: 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.
RECOMMENDATION: In September 2016, Medtronic sent an Urgent Medical Device Correction notice to affected customers. The notice provided a description of the software change, description of labeling changes, 8870 software c...