Medtronic, Model 8870, Application Software Card is part of the SynchroMed¿ II Drug Infusion System. The System includes the SynchroMed¿ II implantable drug infusion pump 8637-20, 8637-40, N'Vision clinical programmer 8840 and the Software application card 8870. || The SynchroMed II Infusion system contains and administers prescribed drugs to a specific site inside patient body. The SynchroMed II Pump is supplied in 20 ml and 40 ml reservoir sizes. In the United States, the SynchroMed II Pump is specifically approved for (indicated): ¿ The chronic epidural/intrathecal infusion of Infumorph (preservative-free morphine sulfate sterile solution) in the treatment of chronic intractable pain. ¿ The chronic intrathecal infusion of Lioresal Intrathecal (baclofen injection) in the management of severe spasticity. ¿ The chronic intrathecal infusion of Prialt (preservative-free ziconotide sterile solution) for the management of severe chronic pain. ¿ The chronic intravascular infusion of floxuridine (FUDR) for the treatment of primary or metastatic cancer. ¿ The chronic intravascular infusion of methotrexate for the treatment of primary or metastatic cancer. Outside of the United States, the SynchroMed II Pump is indicated for the chronic infusion of drugs or fluids tested as compatible and listed in the product labeling for the specific geographies.
“If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.