Medtronic SynchroMed II Pain Pumps
The Medtronic SynchroMed II is a drug infusion pump, commonly known as a pain pump, which delivers pain medication directly into the spinal fluid to relieve chronic pain and spasticity. Since 2009, design defects in the SynchroMed II have led to accidental overdose, underdose, life-threatening withdrawals, and patient deaths.
SYNCHROMED II DESIGN DEFECTS
The SynchroMed II has been linked to two serious problems:
- Pocket Fills– A design defect which can cause the pain medication to be injected into the area under the patient’s skin during refills (instead of into the device itself). “Pocket fills” can lead to overdose and patient death.
- Battery Failures– In some implants, a film develops in the battery compartment that can reduce battery performance and lead to underdosing, resurgence of symptoms, and life-threatening drug withdrawal.
FDA WARNINGS AND RECALLS
- July 2009– Medtronic sends a letter to physicians warning about potential battery problems which could cause the SynchroMed II to fail.
- January 2011– Medtronic sends an urgent letter warning health care professionals about a defect which could lead to “pocket fills” during device refills.
- February 2011- The FDA issues a Class I recall on Medtronic SynchroMed II Infusion Pumps due to the design defect which causes “pocket fills.”
- July 2011– FDA issues a Class I Recall on SynchroMed II Infusion Pumps due to battery issues originally warned against in 2009.