“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.
Endotracheal Tube of EMG Reinforced NIM Standard and Contact, models 8229306, 8229307, 8229308, || 8229506, 8229507 and 8229508, specific lots.
Product Description
This device is intended for the supervision of surgical procedures for patients who require intraoperative monitoring of nerves, whose nature is non-invasive, assisting the surgeon in the location and mapping of the motor nerves through the use of EMG signals and electrical nerve stimulation. This equipment is accompanied by a series of accessories that connect to the patient in order to carry out the follow-up through the different measurements that the device performs.