Medtronic is recalling the SynchroMed II and SynchroMed EL Implantable Infusion Pumps due to a software problem that may cause unintended delivery of drugs during a certain medical procedure.
These devices are programmed to deliver prescribed drugs to a specific site inside the patient’s body, primarily to treat cancer, chronic pain, or severe spasticity. However, during a priming bolus procedure (where a large dose of medication is administered from the device to the patient’s spine), these devices can deliver too much of a drug, followed by too little of the drug.
This can result in overdose or under-dose, either of which can lead to serious adverse health consequences.
For more information, read the FDA alert.