Implantable Infusion Pump Recall Issued Over Possible Foreign Particles and Risk of Pump Stalling
USA- Fda.gov writes that certain models of the SynchroMed II Pump are now subject to a recall. The Medtronic SynchoMed II is an implantable device inserted into a person’s body that delivers a controlled amount of a prescription drug to the patient with a pump and a catheter.
The manufacturer, Medtronic, stated that patients reported instances where the motor would permanently stall because of a flaw with the device. The pump motor assembly may contain foreign particles that can damage the device, causing it to stop functioning.
For patients using the defective pumps, there is a risk of the patient going through withdrawal when they stop receiving the prescribed amount of their medication. The faulty pump will also mean that patients will no longer be treating their condition, and symptoms will likely return. In some instances, the cessation of medication can be lethal. Since the device is implanted, patients will require surgery to replace the defective pump.
The Food and Drug Administration (FDA) is warning healthcare providers and patients about the potential risks of defective drug infusion pumps.
In October, Medtronic informed distributors and hospitals of the issue and instructed them to discard unused products that are part of the recall. The manufacturer does not recommend that medical providers replace pumps that are in use unless they show signs of not working correctly. The replacement surgery contains risks, and the pumps have alarms to indicate when they fail to work. As such, Medtronic recommends that doctors speak with their patients about the risks and the signs of a pump malfunction. Patients should pay attention to alerts on their Personal Therapy Manager Application.
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