NIM 4.0 CONSOLE

Description of Event or Problem

It was reported that sometimes, a message suddenly appears on the screen indicating that one of the cables is not detected, as if it were not connected. This has not been an isolated incident, as several surgeons have observed it on different days. We then have to unplug and reconnect it; the message disappears but may reappear a few minutes later. There was no patient impact related to the event.

Additional Manufacturer Narrative

Continuation of D10: Section D information references the main component of the system. Other relevant device(s) are: Product Id: NIM4CPB1, Serial/Lot #: (b)(6); UDI#: (b)(4); Product Id: NIM4CPB1, Serial/Lot #: (b)(6), UBD: , UDI#: (b)(4). 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.