A software analysis was initiated. Analysis found that the reported behavior was the intended functionality of the software. The software functioned as designed. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
Medtronic received information that, while outside of a procedure, the site was having issues with seeing surgeon profiles and procedures in the spine application software. It was reported that the site checked administrative settings and an error message was received. There was no patient present when this issue was identified. It was late reported that the imaging system tool card had been removed from the navigation system, which subsequently removed all procedures and profiles. To restore functionality, the tool card was re-added and tools were re-installed. Medtronic received information that the issue occurred during testing.
Patient Sequence No: 1, Text Type: D, B5