Medtronic SynchroMed Infusion Pump: a History of Problems

Harrisburg, PAThe dog-eared adage suggesting ‘there is a place for everything, and everything in its place’ certainly applies to marketing undertaken by the pharmaceutical and medical device communities: witness television commercials expounding upon the virtues of a drug, only to have a litany of potentially serious side effects narrated by a nonetheless welcoming voice amidst pleasant music and comforting scenes. Similarly, medical device manufacturers duly note the shortcomings of their devices on their websites, but only after you land on the home page that boasts the virtues of their product. Meanwhile, the plaintiff filing the Medtronic SynchroMed lawsuit, for example, shakes his head as he recalls the time the life-saving device allegedly landed him in the hospital.

One of the more recent lawsuits was filed a year ago August in US District Court for the Middle District of Pennsylvania. Plaintiff Jason Silver alleges that his Medtronic SynchroMed II was defectively designed and prone to malfunctions that may cause serious medication problems.

According to Silver’s Medtronic SynchroMed lawsuit, the plaintiff received a Medtronic SynchroMed II pump, implanted in his abdomen in December 2012 for treatment of chronic pain linked to cervical radiculopathy and cervicalgia. The pump was employed to deliver controlled levels of pain medication into the intrathecal space of his spine. However, in the summer of 2014 the SynchroMed pump malfunctioned and delivered too much medication causing severe pain, nausea and a lack of mobility that required hospitalization.

The Medtronic SynchroMed II is highlighted on the Medtronic home page as a “programmable infusion system that stores and delivers pain medication into the intrathecal space, according to instructions programmed by the clinician. The pump and catheter are implanted under the skin,” according to the manufacturer’s web site.

Medtronic also boasts documented performance: “Infusion dosing must be precise, consistent, reliable – day to day and over the life of the drug delivery system. The SynchroMed II infusion system delivers documented precision and trusted performance. Annual product performance reports share data from a prospective, long-term multi-center registry.”

To the manufacturer’s credit there is a thorough cache of documents associated with Medtronic SynchroMed recall and other issues encountered over the years on a separate page linked to the main page. It’s all there and easily found by way of a link entitled ‘Indications, Safety and Warnings.’

What the user will find is information that suggests a fair number of problems that date back to November, 2006 following reports of patient deaths occurring soon after “the implant or revision of a SynchroMed system.” A subsequent investigation concluded, according to Medtronic, that “available evidence indicates that the infusion systems operated normally, and that device malfunction was not the cause of these adverse events.”

However, that exoneration was only the beginning of a long series of problems associated with the device – duly documented, of course – that have continued up through the years to pretty much present day.

The latest advisory by Medtronic to the medical and regulatory communities is notification of a design change dated August of this year affecting model numbers 8637-20, and 8637-40 of the manufacturer’s SynchroMed II Implantable Drug Infusion Pump. The change, according to the alert, “reduces the likelihood for non?recoverable motor stall, which can cause loss of therapy,” the manufacturer says.

But there have been other, more compelling issues. A Medtronic SynchroMed recall from May 2013 and updated October 3 of last year by the US Food and Drug Administration (FDA) related to priming bolus failure associated with pumps manufactured and distributed from September, 2013 through October, 2016.

Then there has been the battery issue, recently updated in April of this year by the manufacturer related to battery performance of Model 8637 SynchroMed II Implantable Drug Infusion Pump. The original notification was from 2011 for pumps manufactured through June, 2011. The Medical Device Correction Update, available as a link from the Medtronic website, is marked ‘Urgent.’

The battery recall only related to pumps manufactured prior to June, 2011. For those Medtronic patients implanted with a SynchroMed infusion pump prior to June, 2011 there was significant risk of the batteries – normally having a 4 to 5-year lifespan, failing early. The batteries in some pumps were becoming impacted by the development of a thin film, promoting early failure. The FDA, in September 2011, classed the Medtronic SynchroMed recall as a Class 1 recall, which is the most serious recall the FDA can issue, as there was a reasonable likelihood of severe injury causing death.

Early in 2011, the FDA had issued a Class 1 Medtronic SynchroMed Implantable Infusion Pump recall following reports that doctors were accidentally injecting drugs directly into patients’ subcutaneous tissues while attempting to refill the devices. Such “pocket fills” resulted in at least eight deaths, and 270 injuries.

The year prior the FDA, in 2010 indicated it was lowering the boom on infusion pumps – Medtronic included – by stepping up oversight, an initiative duly reflected in a report carried by The New York Times on April 23, that year.

In Pennsylvania, the Medtronic lawsuit is Jason Silver v. Medtronic Inc. et al, Case No. 1:16-cv-01682-JEJ, filed August 12, 2016 in US District Court for the Middle District of Pennsylvania.