Medtronic drug delivery warning gets class I stamp

Medtronic's warning to physicians that its implantable intrathecal drug delivery systems could present a potential risk to patients has been labelled as a class I recall by the US FDA. The Minneapolis, Minnesota-based company received the highest possible recall caution after it informed professionals via a letter in January 2008 that patients receiving therapy through its SynchroMed and IsoMed infusion systems had seen an increase in the rate of reported inflammatory mass cases. The letter, which was an update on communications the company had made in 2001 and 2003, stated that the reported cases of inflammatory mass in intrathecal drug delivery patients had risen from 0.1% in 2001 to 0.5% in 2007. Medtronic said that true incidence rate, which is currently unknown, could be even higher than 0.5% due to under-reporting.

Medtronic's warning to physicians that its implantable intrathecal drug delivery systems could present a potential risk to patients has been labelled as a class I recall by the US FDA. The Minneapolis, Minnesota-based company received the highest possible recall caution after it informed professionals via a letter in January 2008 that patients receiving therapy through its SynchroMed and IsoMed infusion systems had seen an increase in the rate of reported inflammatory mass cases. The letter, which was an update on communications the company had made in 2001 and 2003, stated that the reported cases of inflammatory mass in intrathecal drug delivery patients had risen from 0.1% in 2001 to 0.5% in 2007. Medtronic said that true incidence rate, which is currently unknown, could be even higher than 0.5% due to under-reporting.

The company said that no deaths connected with this issue had been reported, although it did state that frequent symptoms...

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