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

Model Number	POLESTAR
Medical Device Problem Codes	Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138); Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/30/2018
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.The representative was unable to replicate the reported issue.The hardware, software, and instruments passed the system checkout.The system was found to be fully functional.
Event or Problem Description
A site representative reported that, while in a cranial resection, the magnetic resonance imaging (mri) image acquisition discontinued without prompt from the user.The surgeon opted to complete the procedure without the use of the navigation system.There was a reported delay to the procedure of less than 1 hour due to this issue.There was no impact on patient outcome.No additional information was provided.
Additional Manufacturer Narrative
A medtronic representative went to the site to test the equipment.The representative was unable to replicate the issue.System function as expected.
Additional Manufacturer Narrative
The manufacturer representative went to the site to test the navigation system.The reported issue was confirmed and the 'scan' indication lamp (outside of the room) was not working.Opening the operating room (or) door during the scan, due to lack of indication, might cause image artifacts.The site is responsible to fix the 'scan' indication lamp.The msc door mechanic lock was not working.The site is responsible to fixing the door lock.The magnet out indication lamp (outside of the room) was not working.The site is responsible for fixing the lamp.If information is provided in the future, a supplemental report will be issued.

• 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: 7296614
• Report Number: 1723170-2018-00849
• Device Sequence Number: 957776
• Product Code: LNH
• UDI-Device Identifier: 00613994719225
• UDI-Public: 00613994719225
• Combination Product (Y/N): N
• 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,Followup,Followup
• Report Date (Section B): 08/12/2019

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: 01/30/2018
• Supplement Date Received by Manufacturer: 05/15/2018; 07/21/2019
• Initial Report FDA Received Date: 02/26/2018
• Supplement Report FDA Received Date: 06/12/2018; 08/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1