SynchroMed EL and SynchroMed II are infusion pumps manufactured by Medtronic. Unfortunately, they have been linked to hundreds of injuries and several deaths caused by drug overdoses or under-doses in critically ill patients.
FDA Bans Sales of SynchroMed Infusion Pumps
May 22, 2015 — After years of failing to fix safety problems linked to at least 14 deaths, the FDA has ordered Medtronic to stop selling SynchroMed infusion pumps. Click here to read more.
SynchroMed Pain Pumps
Medtronic Inc. manufactures the SynchroMed EL and SynchroMed II infusion pumps. The implantable, programmable medical devices are designed to provide patients with a controlled, continuous supply of medication directly into the spinal fluid for the treatment of chronic pain or muscle spasticity. Medications typically include painkillers and muscle relaxants.
What is the problem?
Medtronic SynchroMed II infusion pumps can deliver too much medicine, also known as over-infusion. Confirmed cases of over-infusion are rare, but if over-infusion occurs, there is a risk of the patient experiencing an overdose. Patients could also go into withdrawal or experience symptoms of their underlying condition if the pump runs out of medicine faster than normal.
What is the risk?
The risk of over-infusion is low. In Australia, the estimated occurrence rate is less than 0.14% (approximately 1 in 700). However, there are several risk-factors that can contribute to the problem:
- Using non-indicated drug formulations
- Over-filling the pump reservoir
- Operating the pump with no fluid in the reservoir
- Catheter blockage
- Pump stops/motor stalls lasting more than 48 hours
SynchroMed Linked to 14 Deaths
In June 2013, the Wall Street Journal has published a study linking the SynchroMed infusion system with 14 deaths. Medtronic has also notified physicians of four defects with the device. The FDA has classified all four issues as Class 1 recalls. According to Medtronic, most of the deaths occurred when patients were deprived of medicine and entered withdrawal or after overdoses.
Baclofen Withdrawal Syndrome
The Medtronic SynchroMed infusion pump is sometimes used to deliver intrathecal Lioresal (baclofen) for people with severe muscle spasticity, a complication of cerebral palsy, multiple sclerosis, stroke, brain injury, or spinal cord injury. If the infusion pump breaks, patients can suffer life-threatening baclofen withdrawal symptoms, such as high fever, changes in mental status, muscle stiffness, and in rare cases organ failure and death.
FDA Warning: Over 500 Complaints
In August 2012, the FDA issued a Warning Letter to Medtronic after receiving 567 complaints of corrosion on the SynchroMed II infusion pump. The FDA is concerned that Medtronic may have endangered patient safety by failing to address the problem, which was discovered in 2007. Click here to read more.
- January 2011 — Recall issued for SynchroMed EL and II because pocket fills (the unintended injection of drugs or fluids into the patient’s subcutaneous tissue at the pump pocket site instead of the pump) may result in patient harm, serious injury, and/or death due to drug overdose or underdose. At least 270 people were injured, including eight people who died of painkiller overdoses.
- July 2011 — Recall issued for SynchroMed II infusion pump due to a battery problem that can suddenly stop infusion. These infusion pumps were recalled for the same battery issue in July 2009.
- June 2013 — Three recalls issued for SynchroMed EL and II due to problems including electrical short-circuiting, occlusion of a catheter, and unintended delivery of drugs during the priming bolus procedure.