Inflammatory mass leads Medtronic to recall implantable pumps

March 26, 2008

Medtronic recalls SynchroMed EL, SynchroMed II, and IsoMed implantable pumps

Formation of inflammatory masses at or near the distal tip of intrathecal catheters has led Minneapolis-based Medtronic Neuromodulation to issue a Class I recall of three of its implantable pumps: SynchroMed EL, SynchroMed II, and IsoMed. Labeling for the devices has been updated to include current patient management and treatment recommendations. The devices are used to administer drugs to a specific site in the body to treat pain, spasticity, and cancer. Masses occurred with intrathecal infusions of opioids, baclofen, pharmacy-compounded drugs, and other admixtures. The highest reported rate was associated with the use of opioids. The most common symptoms include decreased therapeutic response and pain. In the case of intrathecal baclofen, a common symptom is return of spasticity. Practitioners are encouraged to administer the lowest effective dose and concentration of drug possible. Patients receiving baclofen should be monitored for signs and symptoms especially if using pharmacy-compounded drugs or baclofen admixtures that include opioids. Neurosurgical consultation should be considered to confirm or rule out diagnosis of an inflammatory mass.