Medtronic Inc. manufactures the SynchroMed EL and Synchromed II infusion pumps for continuous delivery of painkillers and other medications. Unfortunately, these devices have been recalled several times after they were linked to hundreds of injuries and over a dozen deaths.
UPDATE: Medtronic Synchromed II Pain Pump Lawsuit Moves Forward in West Virginia
In March 2021, a federal judge allowed a Synchromed pain pump lawsuit to move forward against Medtronic. The lawsuit was filed by a 70-year-old man who was injured when his Synchromed II pump suddenly stopped delivering pain medicine.
Medtronic Sets Up $35 Million Settlement Fund for Pain Pump Injuries
In 2009, after numerous reports of problems with Synchromed pain pumps, Medtronic agreed to set up a $35 million settlement fund to pay financial compensation to people who were harmed.
What is the Problem?
In July 2009, Medtronic discovered that many Synchromed pumps were failing because a filmy substance was commonly forming in the pump battery. The problem can cause the pump to suddenly stop delivering pain medicine.
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. The company is also facing a lawsuit from a paralyzed man after the company’s appeal was denied.
What is the SynchroMed Pain Pump?
The SynchroMed EL and SynchroMed II are implanted medical devices known as pain pumps, which are used to infuse medications at a continuous rate into a patient’s body.
14 Deaths Linked to SynchroMed Infusion Pump
In June 2013, the Wall Street Journal reports that 14 deaths were linked to problems with the SynchroMed infusion pumps. Most of the deaths were caused by drug overdoses or under-doses. In response, Medtronic issued four recalls, all of which were classified as Class I by the FDA.
FDA Warning Letter
In August 2012, Medtronic received a Warning Letter after the FDA received reports of 270 serious injuries and 8 deaths linked to the SynchroMed infusion pumps. The agency was concerned that Medtronic failed to address safety problems that were discovered in October 2007. Click here to read more.
Risk-Factors for Over Infusion
The risk of over-infusion is low, with health officials estimating an occurrence rate of less than 0.14% (approximately 1 in 700). The following risk-factors may 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 Pain Pumps and Baclofen Withdrawal
Medtronic SynchroMed is sometimes used to deliver a powerful muscle-relaxing drug called Lioresal (baclofen) into patients who have severe muscle spasticity. This complication is common among people with cerebral palsy, multiple sclerosis, stroke, brain injury, or spinal cord injury. If the infusion pump breaks and drug-therapy is interrupted, the patients can rapidly develop baclofen withdrawal syndrome. Symptoms include high fever, changes in mental status, muscle stiffness, organ failure, and even death.
- January 2011 — The SynchroMed EL and II were recalled because doctors could accidentally administer overdoes of painkillers when trying to refill the pump. This problem was linked to 270 injuries and eight deaths.
- July 2009 and 2011 — SynchroMed II recalled twice for battery problems that could interrupt infusion of medications.
- June 2013 — SynchroMed EL and II recalled for three issues, including electrical short-circuiting, unintended delivery of drugs, and catheter occlusion.