FDA Classifies Medtronic Letter as Class I Recall

Minneapolis, MN-based device maker Medtronic said the FDA has classified its recent communication to physicians related to inflammatory mass formation associated with intrathecal drug delivery as a Class I recall.

On Jan. 16, Medtronic sent a letter to inform clinicians worldwide of an increase in the rate of reported inflammatory mass cases in patients who have received intrathecal drug delivery through its implantable infusion systems. This letter was an update to two previous communications on this topic that Medtronic issued in 2001 and 2003. The classification from the FDA does not change the recommendations made to physicians in the January’s letter and there is no new action required of physicians or patients, according to Medtronic.

Inflammatory masses have been reported in patients who receive intrathecal therapy through the SynchroMed and IsoMed infusion systems. Inflammatory mass is a chronic inflammatory or granulomatous mass at or near the tip of intrathecal catheters and has been reported with the infusion of morphine, baclofen and other physician-prescribed drugs and/or mixtures, including pharmacy-compounded drugs. Medtronic has noted an increase in reported cases of inflammatory mass associated with intrathecal drug delivery.

To date, there have been no reported deaths associated with this issue. The most frequently reported symptoms of inflammatory mass are decreased therapeutic response, pain, and neurological deficit/dysfunction. Serious reported symptoms include paralysis and other neurological impairments.

Medtronic’s intrathecal drug delivery systems consist of an implantable pump and catheter that deliver small quantities of drug directly into the intrathecal space in the spine. These devices are used to treat chronic, intractable pain and for the management of severe spasticity of cerebral or spinal origin.

Medtronic’s January 2008 physician letter provided specific patient management recommendations that include using the lowest effective dose and concentration of opioids and patient monitoring for early clinical symptoms of inflammatory mass. The letter also recommends diagnostic steps for physicians to consider for patients who have new neurological symptoms aimed at preventing more severe outcomes. This letter, which includes additional patient management information, is available through Medtronic’s Web site at www.medtronic.com/im.

“Patient safety is our highest priority. Our communication to physicians reflects the importance we place on tracking product performance and reporting information that is useful to our customers in providing appropriate patient care,” said Richard E. Kuntz, MD, senior vice president and president of the Neuromodulation business at Medtronic.