MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (ISRAEL) POLESTAR N30 SURGICAL MRI SYSTEM; SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING

Model Number	POLESTAR
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	02/22/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No patient information provided as no patient was involved in this concern.During the onsite inspection, the medtronic representative reported that the emergency button on the left side of the scanner had been switched on.The medtronic representative unlocked the system which resolved the issue.After the system started up, it was re-homed.The system was found to be fully functional after this.
Event or Problem Description
A site representative reported that the tool had been blocked by the scanner.The site used the manual open procedure to open it and then attempted to restart the system, but it would not startup.No patient was present during the time of the reported incident.

• Brand Name: POLESTAR N30 SURGICAL MRI SYSTEM
• Common Device Name: SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC. (ISRAEL); p.o. box 548; kochav yokneam bldg.; yokneam elit 20692 ; IS 20692
• MDR Report Key: 6432046
• Report Number: 1723170-2017-01323
• Device Sequence Number: 13578323
• Product Code: LNH
• UDI-Device Identifier: 00613994719225
• UDI-Public: 00613994719225
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K092308
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 03/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Model Number: POLESTAR
• Device Catalogue Number: 9734070
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/24/2017
• Initial Report FDA Received Date: 03/24/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1