“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.
It is indicated for use when the patient's therapy requires cornica medication infusion. The system is approved for use with: sterile solution of demorphine hydrochloride / morphine sulfate free of preservatives in the treatment of intractable chronic pain. Intrathecal injection debaclofen in the management of severe spasticity. Sterile solution of ziconotide free of condoms for severe chronic pain management. chronic intravascular infusion defloxuridine and methotrexate for the treatment of primary or metastatic cancer (not for use with the intrathecal catheter ascends)