Medtronic Inc.’s Synchromed pump devices are surgically implantable devices meant to deliver medication to an area near a patient’s spinal cord. The SynchroMed II drug pump system is used to treat patients who have been diagnosed with cancer, severe muscle spasms, chronic pain, and other serious disorders and who do not respond to oral medications or who have suffered severe side effects associated with oral medications.
More than 200,000 Medtronic SynchroMed devices have been implanted worldwide, according to Medtronic.
As of April 2015, dozens of recalls have been issued over the Medtronic SynchroMed infusion pump system; more than 30 of these recalls have been deemed Class I recalls by the U.S. Food and Drug Administration (FDA). A Wall Street Journal report also found that at least 14 deaths were tied to the system and federal regulators sent a number of warning letters to Medtronic and made several investigative visits to Medtronic’s Minnesota manufacturing plant.
Medtronic continues to maintain that, as recently as April 2015, the defective SynchroMed implantable devices need not be removed from the hundreds of thousands of patients who have been implanted with the pain pumps.
Parker Waichman is horrified at the ongoing lack of action regarding the Medtronic SynchroMed implantable device system and is accepting Medtronic implantable drug pumps lawsuits complaints. Lawyers at our firm who specialize in Medtronic class action lawsuits are offering free legal consultations to individuals who have been implanted with a Medtronic SynchroMed infusion system and who are concerned about potential injuries associated with the device.
MEDTRONIC ISSUES GLOBAL RECALL OF MINIMED INFUSION SETS
Medtronic initiated a global recall of specific lots of its MiniMed infusion sets, which are used with all models of Medtronic insulin pumps. The company indicated that it has determined that the vent membrane in the recalled MiniMed infusion sets may be susceptible to being blocked by fluid during the process of priming/fill-tubing, according to a September 11, 2017 Medscape Medical News reported. Medtronic indicated in a news release that, “This situation can lead to potential over-delivery of insulin shortly after an infusion set change, which may cause hypoglycemia.”
Currently manufactured Medtronic MiniMed infusion sets that have been available since April 2017 include a design update of the defective component that Medtronic believes minimizes risks for insulin over-delivery following an infusion set change. Medtronic recommends customers—effective with their next set change—only use infusion sets manufactured with the new, enhanced component, which is known as the vent membrane. Medtronic suggests that customers check online to determine if they are in possession of the recalled infusion sets. The specific lots of infusion sets are used with all models of Medtronic insulin pumps and does not include insulin pumps or glucose sensors.
“Because this recall applies to all versions of infusion sets that are used with Medtronic insulin pumps, to publish a list of specific lot numbers would be unwieldy,” said Pamela Reese, Medtronic senior manager for communications. Ms. Reese also told Medscape Medical News that, “This is why we designed the [online] lot look-up tool. When using this lot look-up, customers will be able to automatically process the exchange for new sets as well.” She added, “It is difficult to predict how many unused, recalled infusion sets are in customer hands that will need an exchange. Most customers likely have a mixture of recalled and new infusion sets in their possession.” The online tool is available on the Medtronic website.
Medtronic also reminded customers that it is very important to carefully follow the Key Steps document included with the recall notification letter regarding the priming/fill-tubing process, especially if a patient only has recalled infusion sets in his/her possession.
Federal Regulators Issue Consent Decree Ordering Medtronic Inc. to Cease Producing, Distributing, Most Synchromed II
Implantable Pump Devices
According to the FDA, Medtronic Inc.’s Synchromed implantable pump devices have been the focus of a number of warning letters issued by the agency over a nine-year period. On April 27, 2015, the FDA announced that, following years of problems that were not corrected by the device maker, Medtronic has been advised that it must stop selling and distributing most of its implantable Synchromed II drug pumps devices. Quality control and manufacturing problems at Medtronic’s Minnesota drug pump facility between 2006 and 2013 were cited. The letter noted that the FDA conducted five visits at the site. The proposed consent agreement was reached in collaboration with the U.S. Department of Justice (DOJ) and involved defects in the Synchromed drug infusion pump that had been tied to serious injuries and deaths; allegations that Medtronic’s CEO, Omar Ishrak, and its neuromodulation business chief, Thomas Tefft, sold medical devices that did not comply with federal manufacturing standards under the Food, Drug and Cosmetic Act; and claims that Medtronic routinely neglected to correct FDA quality regulation violations. Inspections conducted in 2006 and in 2013 revealed what the government described as “significant violations” of quality regulations, including those concerning complaint handling and corrective and preventive action, which are meant to ensure a malfunction that may potentially lead to injury or death is investigated and that appropriate changes are made, noted The Wall Street Journal.
Under the proposed decree, Medtronic must cease manufacturing and distributing new versions of the SynchroMed II implantable pump.
Reports of Deaths Associated with the Medtronic SynchroMed EL Infusion System
Medtronic Inc. indicates that the SynchroMed EL infusion system, also known as a Medtronic intrathecal pain pump, is an implantable, programmable drug delivery system that 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 Medtronic’s pain pump, noting that 14 deaths had been associated with the SynchroMed infusion system. The majority of the deaths occurred when patients who had been implanted with the device had either gone into withdrawal or overdosed, according to a Medtronic spokeswoman.
Medtronic indicated that it 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 an alert that the Medtronic SynchroMed implantable infusion pump motor has stalled.
Medtronic also 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 (FDA) classified all four Medtronic pain pump recalls as Class 1 recalls, meaning that the SynchroMed device has the potential to cause serious injury or death.
Medtronic SynchroMed Implantable Infusion Pump Recalls
In August 2007, Medtronic Inc.’s SynchroMed El Implantable Infusion Pumps were the subject of a Class I FDA Medtronic pump recall. According to the FDA recall notice posted on the agency’s website in February 2008, one of the pain pump side effects involved the Medtronic SynchroMed El Implantable Infusion Pumps stalling 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.
Among other issues, some Synchromed devices have been recalled due to loss of battery power. Battery power issues may lead to device failure and, in some cases, the release of too much or too little medication.
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 pump recall by letter dated August 3, 2007.
The FDA issued a warning letter in 2012 to Medtronic citing the device maker for not correcting problems with the devices, such as the SynchroMed’s potential to stall due to motor corrosion and its failure to deliver medication.
As of April 8, 2015, the FDA identified more than 30 Class I recalls associated with the Medtronic SynchroMed infusion pump system, the complete, updated Synchromed pumps recall list is accessible here.
Overdoses, Withdrawal Among the Critical Issues Associated with Medtronic’s SynchroMed Pump
Of the reported deaths associated with the Medtronic pain 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 between 2007 and February of 2013. An electrical short caused one death, which occurred in March 2013. One of the alleged defects associated with the device is that the SynchroMed pumps lose battery power.
Medtronic responded to the report by sending healthcare professionals recommendations regarding the Synchromed pump-priming mechanism, which may contribute to the risk of improper dosing, while the company indicated that it continues to investigate the issue and determines appropriate product updates.Another notice, focused on Synchromed pump fails includes the potential for electrical shorts. The notice was sent to patients, urging them to contact their physicians in the event an alarm when the Medtronic infusion pump is in use. At the time the notice was issued, Medtronic did not recommend SynchroMed II pain pump removal unless the system showed signs of malfunctioning. Medtronic estimated that the failure rate was less than 1 percent seven years following implant.
Legal Help For Victims Affected by the Medtronic SynchroMed Implantable Infusion Pump
If you or a loved one were injured as a result of a defective Medtronic SynchroMed Implantable Infusion Pump, you have valuable legal rights. Please fill out our online form or call 1-800-YOURLAWYER (1-800-968-7529) for a free case evaluation by a qualified medical device attorney.