The Food and Drug Administration (FDA) has recently classified a “warning” sent out by Medtronic, Inc. to health professionals as a Class 1 recall. A Class 1 recall is the most serious type of recall order issued and involves situations in which there is a reasonable probability that use of the product will cause serious injury or death. The device being recalled is an implantable pump that delivers drugs into the body. The product technical name is: Medtronic Neuromodulation INDURA One-Piece (IP) Intrathecal Catheters, Sutureless Pump Connector Revision Kit, and Intrathecal Catheter Pump Segment Revision Kit. This is an illustration of a typical intrathecal medicine delivery system.
Patients receive infused drugs (typically for pain management) through the pump, and it was recently reported in the Minneapolis Star-Tribune that 83 patients have been identified as having pumps with improper connections, and one patient has died.
Patients are urged to immediately contact their physicians regarding these devices. The connections, if improper, can cause leaking of pain medication into the body, with the potential for fatal overdose.
Earlier this year, Medtronic the FDA considered a warning issued by Medtronic regarding another of its infusion devices, and also determined that the issue warranted a Class 1 recall. The Medtronic Neuromodulation SynchroMed EL, SynchroMed II and IsoMed Implantable Infusion Pumps were recalled after a letter was sent reporting inflammatory masses at the site of these pumps – also used for pain management, as well as cancer treatment infusion.
If you have any questions or concerns regarding medical devices and cannot find answers through the FDA website, contact an experienced attorney and seek advice.