Recall: Medtronic Reports Problems with IsoMed and Synchromed Intraspinal Pain Pumps
Posted by
Armand RossettiOctober 27, 2008 5:18 PMTags: Recall,
Medtronic,
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SynchroMed,
IsoMed,
drug,
overdose
Medtronic’s SynchroMed and IsoMed intraspinal pain pumps consist of an abdominally implanted drug fluid reservoir equipped with a catheter. The catheter ends with a tip, which the surgeon implants within the fluid-filled spinal column. Once implanted, doctors can program the SynchroMed and IsoMed pain pumps to deliver metered doses of opioids to control pain over long periods of time up to several years. The reservoirs are refillable and the catheters, replaceable.
On January 16, 2008, Medtronic sent an urgent medical device correction letter (also known as a dear doctor letter) to healthcare professionals containing a warning about an increased rate of inflammatory masses in patients using their Synchromed and IsoMed model spinal infusion pain pumps.
Shortly after reviewing a copy Medtronic’s January correction letter, the FDA reclassified the letter on March 19, 2008 as a Class I recall. An explanation of the severity of a Class I recall follows:
“Class I recalls are for dangerous or defective products that predictably could cause serious health problems or death. Examples of products that could fall into this category are a food found to contain botulinal toxin, food with undeclared allergens, a label mix-up on a life saving drug, or a defective artificial heart valve.”
According to the FDA, Medtronic’s original January letter was an update to two earlier communications: one entitled: Implanting physician advisory: Important message regarding the occurrence of inflammatory masses at the tip of intraspinal catheters, released on January 19, 2001, and the second communication was a July 3, 2003 Medtronic Educational Brief, entitled Tools for Safe Patient Management. The July 3, 2003 bref concluded with a statement requesting anyone detecting new and/or previously unreported intraspinal masses to report them to Medtronic Neurological Product Performance.
Notwithstanding the 2003 request for prompt reporting, Medtronic received a reporting related FDA communication on July 30, 2007, concerning problems at Medtronic's Minneapolis plant. “After becoming aware of information suggesting that its intraspinal device may have caused or contributed to death or serious injury," Medtronic had failed to submit 37 adverse event reports.
More recently in May 2008, Medtronic issued another detailed recall for its SynchroMed II model intraspinal pump warning about missing propellant in the pump’s reservoir. The “Drug Overdose” section on page 3 of that missing propellant letter explains how a physician who is unaware of the problem might actually cause a serial increase the concentration of drug in the reservoir and inadvertently cause an eventual patient drug overdose.
Interestingly enough, some investigators have suspected that the appearance of inflammatory masses at the tip of catheters implanted within the spinal column might be dose related, at least in part.