Medtronic Recalls Intrathecal Infusion Pumps
Tuesday, March 25, 2008
On March 21, 2008, the FDA issued a class 1 recall for Medtronic Neuromodulation's implantable infusion pumps. Affected devices include SynchroMed EL (models 8626-10, 8626-18, 8626L-10, 8626L-18, 8627-10, 8627-18, 8627L-10, and 8627L-18), SynchroMed II (models 8637-20 and 8637-40), and IsoMed (models 8472-20, 8472-35, and 8472-60).The action was based on reports of inflammatory mass (granuloma) formations at or near the distal tip of intrathecal catheters used to infuse opioids, baclofen, or chemotherapy drugs, according to an alert issued by MedWatch, the FDA's safety information and adverse event reporting program.
In a letter to healthcare professionals, the company noted that the reported incidence of inflammatory mass with intrathecal drug delivery has increased 5-fold from 2001 to 2007 (0.49% vs 0.1%) and is expected to continue increasing. Symptoms most commonly include decreased therapeutic response/inadequate pain relief (33.5% of cases), pain (32.6%), and neurologic deficit/dysfunction (17.4%).
Because the risk for inflammatory mass appears to be cumulative over time and increases with higher doses and/or concentrations of opioids, the lowest effective dose and concentration should be used.
Patients receiving intrathecal baclofen therapy for spasticity should be closely monitored for prodromal clinical signs and symptoms of inflammatory mass, especially when using pharmacy-compounded medications or baclofen admixtures that contain opioids.
For new neurologic symptoms, a neurologic consult and imaging procedures should be considered to confirm or rule out an inflammatory mass.
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. They are indicated for the treatment of chronic, intractable pain and for the management of severe spasticity of cerebral or spinal origin.
Additional information regarding the use of implantable intrathecal infusion pumps may be obtained by calling 1-800-707-0933 from Monday to Friday, 7:00 am to 6:00 pm (Central Standard Time) or by contacting the company online at http://www.medtronic.com/corporate/contact.jsp.
Pump-related adverse events should be reported to the company by telephone at 1-800-328-0810 and to the FDA's MedWatch reporting program by telephone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online at http://www.fda.gov/medwatch, or by mail to 5600 Fishers Lane, Rockville, MD 20852-9787.