Pain Pumps

Pain Pumps

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:

  • Unintended delivery of drugs from system delivery error which can result in drug under- and overdose, leading to respiratory depression, coma or death
  • Battery failure and electrical shorting, internal to the infusion pump, resulting in serious adverse health consequences including death.
  • Intrathecal pain medication withdrawal: Abrupt discontinuation of pain meds can result in high fevers, altered mental status, exaggerated rebound spasticity, and muscle rigidity.

Links

FDA Class I Recall Medtronic SynchroMed II & SynchroMed EL

The Wall Street Journal: Medtronic in FDA Consent Decree Over Its SynchroMed Infusion Pump, Wall Street Journal, April 27, 2015