The SynchroMed II is a pain pump manufactured by Medtronic. It is a programmable infusion pump which is implanted in the body for continuous drug delivery to a specific site to treat chronic pain.
In April, 2015, the FDA filed a consent decree of permanent injunction, against Medtronic for violating Current Good Manufacturing Practices. Medtronic was required to suspend manufacturing and distribution of the SynchroMed implantable pumps.
Problems with the pumps include:
The Wall Street Journal: Medtronic in FDA Consent Decree Over Its SynchroMed Infusion Pump, Wall Street Journal, April 27, 2015