Medtronic SynchroMed Pain Pump Linked to Dosing Errors, Deaths. Medtronic PLC is facing scrutiny over its SynchroMed II infusion pump, a pain pump that slowly delivers pain medication through a patient’s spinal canal. The SynchroMed II infusion pump is used for conditions such as advanced metastatic cancer, chronic pain and severe spasticity. Over 238,000 Medtronic Infusion pumps have been implanted. The SynchroMed has raised safety concerns due to dosing errors. This potentially fatal issue, referred to as “overinfusion”, occurs when the SynchroMed II administers more pain medication than intended. Over the years, the pain pump has been linked with over a dozen deaths. The device has also been subject to several recalls for various reasons.
Overinfusion with the SynchroMed was first identified in March 2014. Regulators in the United Kingdom released an update in October 2016, citing additional SynchroMed deaths. Medtronic has also faced backlash from the U.S. Food and Drug Administration (FDA) regarding infusion pain pumps. In April 2015, the FDA announced the filing of a consent decree against two Medtronic officers for repeatedly failing to address violations involving the SynchroMed II Implantable Infusion Pump Systems. The FDA issued the consent decree following a series of SynchroMed recalls, which were linked to 14 deaths.
2 More Patients Deaths Linked Medtronic SynchroMed II Infusion Pump
In October 2016, the U.K’s Medicines & Healthcare Products Regulatory Agency published a letter from Medtronic to healthcare professionals regarding SynchroMed II pump overinfusion. The letter was an update to a March 2014 communication. Based on data from Medtronic’s prospective, long-term multi-center registry study, the company says there were five reports of overinfusion as of January 2016. Medtronic says all cases of overinfusion in the Registry involved situations where the pumps were being used to infuse drugs not approved for the SynchroMed II pump. Using a drug in a manner not approved by regulators is referred to as “off-label” use.
The letter updated doctors and other healthcare professionals regarding adverse events reported with the infusion pain pump. As of July 5, 2016, 103 pumps were implicated in adverse event reports. The letter stated, “Medtronic has been unable to establish a definitive causal relationship between the adverse events and overinfusion due to potential contributing factors. However, it is reasonable to conclude that overinfusion was a contributing factor in these cases. Adverse events reported with the Medtronic infusion device varied. Some reported temporary discomfort while others reported life-threatening overdose and/or withdrawal. The letter states that the Medtronic SynchroMed II infusion pump is linked to two additional deaths since the last update was released. According to the letter, 99 out of 103 pumps were associated with the use of non-indicated drug formulations at the time of the last refill. The pain pumps were implanted for an estimated 3.7 years, the letter states.
The letter explains that overinfusion is when the pump delivers more drug volume than programmed. If overdosing occurs with the infusion pump, patients may exhibit overdose symptoms. Additionally, the pump reservoir will deplete faster than expected, the letter notes. If the reservoir depletes before the scheduled refill date, the patient could experience underdose or withdrawal symptoms.
Medtronic Scrutinized for Infusion Pain Pump Violations, Recalls
Parker Waichman injury lawyers note that Medtronic has faced regulatory backlash regarding the SynchroMed II Infusion Pumps in the past. Following a series of recall notices, the FDA announced a consent decree in April 2015. The decree, which resembles a legal settlement but instead mandated strict regulations of manufacturing and distribution, was filed against Medtronic executives Omar Ishrak and Thomas Tefft. The agency said the consent decree was filed “for repeatedly failing to correct violations, related to the manufacture of” infusion pain pumps.
The letter cited violations at Medtronic facilities in Columbia Heights, Minnesota where the SynchroMed is manufactured. The agreement required Medtronic to stop manufacturing, designing and distributing new pain pumps except in limited situations, such as when a physician determines that it is appropriate. The FDA also ordered Medtronic to recruit a third-party expert to help address infusion pump violations. The letter was issued following a series of recalls.
The SynchroMed II Implantable Infusion Pump Systems were approved in 2004. The FDA says it first discovered problems with the manufacture of the pain pumps in 2006, which could result in overinfusion or underinfusion. The FDA inspected Medtronic Neuromodulation five times between 2006 and 2013, and issued three warning letters. The agency said “violations included inadequate processes for identifying, investigating, and correcting quality problems with the SynchroMed II Implantable Infusion Pump Systems; failure to document design changes; and failure to ensure that finished products meet design specifications.”
The infusion pump was associated with 14 deaths at the time. Among those, 11 deaths were linked to the pain drugs being injected into the tissue near the pump, as opposed to the pump itself, during refills. Another issue was the misalignment of the drug-delivery tube and the pump’s connection site, which was linked to two deaths. One patient died due to loss of infusion therapy, possibly related to an electrical short.
Medtronic’s infusion pump has been the subject of several recalls. In 2012, a Class I recall was issued for the SynchroMed II pumps because they failed at a higher rate than expected. A Class I recall indicates a reasonable risk of serious injury or deaths. A Class I recall was also issued in 2011 over a battery defect that can lead to device failure. By the time the battery defect issue was made public, the infusion pump had already been tied to over 50 reports of battery failure.
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