“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.
RestoreUltra model - 97712 and RestoreSensor - 97714, used with "8870" application card and with programmer || medical "8840"
Description du dispositif
The MEDTRONIC ITREL® NEUROSTIMULATOR is part of a neurostimulation system for therapy against pain. It is indicated for spinal cord stimulation (SCS) therapy against chronic intractable pain, trunk and / or extremities, peripheral vascular disease, or intractable angina pectoris. It is also indicated for the stimulation of the peripheral nerve (PNS) as an aid in the management of chronic pain, difficult to treat the posterior trunk and / or extremities.