Concomitant medical products: section d information references the main component of the system.Other relevant device(s) are: product id: 9735825r, ubd: unknown, udi#: unknown h3, h6: no products have been returned to medtronic for analysis.Codes b17, c20, and d15 are applicable.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
|
Medtronic received information regarding a navigation system being used outside of a procedure.It was reported that while on site t roubleshooting a separate issue, the system had displayed a localizer faulted message while utilizing the em function on the system.Troubleshooting was performed.Technical services (ts) had the local representative (csm) connect the break out box (bob) to the system along with the side electromagnetic (em) emitter.The localizer was functioning as intended, however, the em instrument box displayed a yellow light on port 3.Ts had the csm plug the instrument into port 3, but was unable to track the instrument.It was noted that the probable cause of the issue was the bob.There was no patient involvement.
|