The SynchroMed II and SynchroMed Implantable Drug Infusion Pumps, made by Medtronic, are programed to deliver prescribed drugs to a specific site inside the patient’s body, typically the spine. The FDA issued a Class 2 recall nine years ago, in May of 2008, in response to reports of shaft wear and potential misconnections of the Medtronic sutureless connector (“SC”) catheters from the catheter port on the pump. The Medtronic Neuromodulation INDURA IP recall was prompted by the potential for life-threatening blockages.
The following year, in 2009 Medtronic was faced with two recalls: pacemakers marketed under the Kappa and Sigma brand, followed by a Medtronic insulin pump recall involving its MiniMed Paradigm insulin pumps. That same year, in June the FDA took Medtronic to task for taking too long to recall the defective SynchroMed II pumps recalled 13 months prior. The FDA also reminded Medtronic the device maker knew about deficiencies at a manufacturing facility in Puerto Rico nearly two years before triggering the recall in May, 2008.
In 2012 Medtronic issued a safety communication to its customers over the potentiality for double the rate of device failure should unapproved drugs be used in concert with their SynchroMed pumps.
By 2015 it appeared as if the FDA had reached the end of its rope – after issuing dozens of letters to Medtronic over various issues with its SynchroMed pumps – and the regulator initiated what was characterized as a manufacturing ban on the Medtronic SynchroMed II Implantable Infusion Pump Systems.
How all this impacts the individual is best illustrated by drilling down into the Medtronic lawsuit filed by Richard and Mary Lou Stengel in Arizona, in 2010.
According to the Medtronic SynchroMed lawsuit, the Medtronic SynchroMed Pump & Infusion System received premarket approval (PMA) from the FDA in 1988, and its SynchroMed EL Pump and Catheter received approval through a ‘supplemental’ PMA in 1999. “The device is a system for infusing pain medication into the spine,” Court documents said.
“Over the next few years, Medtronic became aware that a granuloma (a nodule of inflammatory cells) could form at the tip of the catheter, which had the potential to paralyze the patient.
“Medtronic did not report this problem to the FDA,” the lawsuit says. “Meanwhile, in October 2000, in Tucson, Arizona, Richard Stengel had the Medtronic infusion pump and catheter system surgically implanted. The catheter was implanted inside the membrane surrounding his spinal cord. The pump delivered pain medication through the catheter tip directly to his spinal cord.”
Court heard that Stengel suffered a fall in 2005 after experiencing decreased sensation in his right leg, and difficulty with urination. An initial consultation with a neurosurgeon failed to diagnose the problem, as the doctor was unaware, according to court records, that the “Medtronic infusion pump could cause a granuloma to form at the catheter tip.”
Stengel was seen by a second physician a few days later, who noted in a subsequent evaluation that Stengel was continuing to experience “ascending paralysis in both legs.” The second consulting physician suspected a granuloma based on prior experience with a previous patient, and ordered tests which confirmed a granuloma caused by the Medtronic pump catheter tip had caused a complete blockage of the spinal fluid, “and compressed the spinal cord at the T12 level in his spine,” the lawsuit said.
Surgery to remove the catheter and most of the granuloma in the plaintiff’s spine was only partly successful, and “as a result of the granuloma caused by Medtronic’s device, [the plaintiff] is permanently paralyzed below the T12 level, in both legs.
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The lawsuit went on to allege that Medtronic knew as early as 2001 with regard to the possibility of an inflammatory mass developing at the catheter tip.
“Mr. Stengel and his wife filed suit against Medtronic in an Arizona state trial court,” stated documents issued by the plaintiffs in the Medtronic lawsuit. “The complaint alleged state-law claims of strict liability, breach of warranty, and negligence, including negligent design and negligent failure to provide adequate warnings. Medtronic removed the case to federal court on diversity grounds and moved to dismiss based on preemption.”