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

Model Number	POLESTAR
Medical Device Problem Code	Failure to Fire (2610)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/30/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information was unavailable from the site.A medtronic representative went to the site to test the equipment.Testing revealed that the system was functioning as intended.The system passed the system checkout and was found to be fully functional.
Event or Problem Description
Medtronic received information regarding an imaging device being used for a cranial resection procedure.It was reported that the software displays an error relating to temperature, not allowing the system to perform a scan.There was no impact to patient.There was a reported delay to the procedure of less than 1 hour due to this issue.

• Brand Name: POLESTAR N30 SURGICAL MRI SYSTEM
• Common Device Name: SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• MDR Report Key: 7806598
• Report Number: 1723170-2018-04174
• Device Sequence Number: 13836965
• Product Code: LNH
• UDI-Device Identifier: 00613994719225
• UDI-Public: 00613994719225
• Combination Product (Y/N): N
• Initial Reporter Country: ES
• PMA/510(K) Number: K092308
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/22/2018

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: Health Professional
• Device Model Number: POLESTAR
• Device Catalogue Number: 9734070
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/31/2018
• Initial Report FDA Received Date: 08/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1