Medtronic SynchroMed Implantable Pump Recall
Medtronic’s Implantable SynchroMed Infusion Pump Includes Critical Side Effects
Medtronic SynchroMed Implantable Infusion Pump Recall | Lawsuits, Lawyers | Side Effects: Serious Injury, Death | Gear Shaft Wear, Defective Medical Devices
The Medtronic SynchroMed EL infusion system is an implantable, programmable drug delivery system, according to the company. The SynchroMed EL programmable infusion system uses a catheter to deliver precise amounts of pain medication or intrathecal baclofen (a muscle relaxant and antispasticity agent) directly to the spinal cord’s cerebrospinal fluid.
In mid-2013, the Wall Street Journal ran an article about the device, noting that 14 deaths have been associated with the SynchroMed infusion system. The majority of the deaths occurred when patients implanted with the device had either gone into withdrawal or overdosed, said a Medtronic spokeswoman.
The company does not recommend patients have the devices removed; patients should, however, contact their physicians immediately if they notice: a change or return of symptoms, or hear an alarm – which is designed to sound the alert that the device's motor has stalled.
The company identified four issues with the device, which it communicated to physicians earlier in June 2013, and two that had been previously reported. The U.S. Food and Drug Administration has classified all four as Class 1 recalls, meaning the device has the potential to cause serious injury or death.
Overdoses, Withdrawal Among the Critical Issues of Medtronic’s SynchroMed
Of the deaths due to the infusion pump, 11 occurred between 1996 and April of 2013; all were attributed to patients being accidentally injected with drugs as part of a medication-refill procedure, according to the Wall Street Journal. A blockage that stopped the drug’s flow led to two deaths, which occurred around between 2007 and February of this year, while one death, in March of this year, was caused by an electrical shorting.
More than 200,000 SynchroMed devices have been implanted worldwide, the company said.
The company has responded by sending health-care professionals recommendations regarding the device's pump-priming mechanism, which can contribute to the risk of improper dosing, while the company continues to investigate the issue and determines appropriate product updates.
Another notice, focused on the potential for electrical shorts, was sent to patients, urging them to contact their physicians in the event of an alarm.
The company isn't recommending removal of the device unless it shows signs of malfunctioning. Medtronic estimates the failure rate at less than 1% seven years after the implant.
Medtronic SynchroMed Implantable Infusion Pump Recall
In August 2007, Medtronic Inc. SynchroMed El Implantable Infusion Pumps were the subject of a Class I Food & Drug Administration (FDA) recall. According to the FDA recall notice posted on the agency’s website in February 2008, the Medtronic SynchroMed El Implantable Infusion Pumps stall at an unusually high rate, putting patients at risk of serious injury or even death. The FDA only issues Class I recalls when there is a reasonable probability that use of a defective medical device will cause serious injury or death.
The implantable Medtronic SynchroMed EL Programmable Pump is part of the SynchroMed EL Infusion System. The Medtronic SynchroMed El Implantable Infusion Pump recall involved models 8626-10, 8626L-10, 8626-18, 8626L-18, 8627-10, 8627L-10, 8627-18, and 8627L-18. Only those models with motors manufactured before September 1999 are affected by the recall.
According to the FDA recall notice, Medtronic notified its customers of the SynchroMed El Implantable Infusion Pump via a letter dated August 3, 2007.
Legal Help For Victims Affected by the Medtronic SynchroMed Implantable Infusion Pump
If you or a loved one where injured as a result of a defective Medtronic SynchroMed El Implantable Infusion Pump, you have valuable legal rights. Please fill out our online form or call 1-800-LAW-INFO (1-800-529-4636) for a free case evaluation by a qualified medical device attorney.