| Medtronic Implantable Fusion Pump Recall |
Nationwide Recall of Medtronic Neuromodulation Implantable Infusion PumpsOn March 21, 2008, the U.S. Food and Drug Administration (FDA) announced a nationwide Class 1 recall for implantable fusion pumps manufactured by Medtronic Neuromodulation, a subsidiary of Minneapolis, Minn.-based Medtronic Inc. The implantable pumps deliver drugs directly into the intrathecal space in the spine, and are used for treatment of patients suffering from chronic pain, and for the management of severe spasticity of cerebral or spinal origin.Medtronic Implantable Infusion Pumps Recall DetailsThe Medtronic Implantable Infusion Pump recall has been classified by the FDA as a Class 1 recall, the most serious type of recall handled by the FDA. Class 1 recalls are based on the reasonable probability that use of the product will cause serious injury or death.The 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). Adverse Reactions Among Users of Medtronic Implantable Infusion PumpsThe Medtronic Implantable Infusion Pump recall is based on reports of inflammatory mass (granuloma) formations at or near the distal tip of intrathecal catheters. These inflammatory masses cause decreased therapeutic response, pain, and neurological deficit/dysfunction. Patients have reported serious symptoms that include paralysis as well as other neurological impairments.If you or a loved one has suffered any adverse side effects due to use of a Medtronic Infusion Pump, please contact our office for a free evaluation. Visit the FDA website for more details on the Medtronic Neuromodulation Implantable Infusion Pumps recall. |
